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Regulatory Webinars - Archived

There are a wide range of topics covered under this listing of “regulatory webinars” - from current updates from the FDA and EMA and risk minimization procedures, to issues surrounding IRBs. The regulatory webinars listed here are recordings of past events. Simply register, for free, for any webinar by clicking the download archive button on each webinar page. If “regulation” is to broad a term, don’t forget, you can search our webinar catalog using the search bar, or, if you’re looking for something else, browse through our other topics.

  Synopsis Webinar Title Date

LifeScience - Join the speakers as they discuss an approach to evidence-generation strategies in drug and medical device development that enables integrated teams to develop and implement targeted and effective value propositions
Paul Just, PharmD, Senior Principal, Medical Device Health Economics, Commercialisation & Outcomes, ICON
Sarah Clifford, PhD, Senior Principal, Clinical Outcomes Assessments, Commercialisation & Outcomes, ICON
Linking Evidence and Value Strategies with the Right Stakeholder Oct 13, 2017

LifeScience -  In this session, you will learn about Systech’s ability to create trusted uniqueness in every product, and how this idea is central to a modern approach to brand protection
Speaker: Jim Sinisgalli, Director of Product Management and Brand Protection, Systech
Why Making Every Product Truly Unique is the Key to Modern Brand Protection Sep 6, 2017

LifeScience - This webinar will discuss the steps that medical device manufacturers should take now to effectively prepare for the new standard by the mandatory implementation date in 2019
Speaker: Linda Mummah Schendel, Principal Medical Research Manager, NAMSA
ISO 13485:2016 for Medical Device Manufacturers: Ensuring a Smooth Transition through Effective Preparation Aug 31, 2017

LifeScienceMetrics are central to efforts to rein in clinical trials that are either poorly initiated or have incurred unforeseen events, which place the original timelines and/or budgets at risk of overages. They also drive competitive performance among those organizations performing trials.
Speakers: Barry Milton, Head of Business Operations, Novartis
Jeffrey Kasher, President, Patients Can't Wait
Rob Wynden, VP Technology & Engineering, goBalto
Moving Beyond Regulatory and Performance Metrics in Starting Clinical Trials Aug 29, 2017

LifeScienceThis webinar will discuss steps to ensure regulatory compliance and an uninterrupted supply of medical devices in the marketplace, and share insight and best practices from experience in navigating US and global regulations on medical device development
Speakers: Angela Stokes, Senior Director, Regulatory Consulting, INC Research/inVentiv Health
Eric Distad, Executive Director, Clinical Development, Medical Device and Diagnostics, INC Research/inVentiv Health
Medical Devices: Reviewing Regulatory Changes in the US and EU Aug 24, 2017

LifeScience -  This webinar will help viewers understand the most recent and significant regulatory shifts in China and Japan including new product classifications, how to successfully prepare for the process of category registration, the best-fit submission framework to reduce development costs and expedite market introduction timelines, and identify the appropriate development strategy for optimal results
Speakers: Kei Yoshikawa, Medical Research Manager, NAMSA
Lei Yang, Medical Research Manager, NAMSA
Understanding Medical Device Regulatory Pathways in China and Japan Jul 20, 2017

LifeScience - In this practical, guidance-filled webinar, the speakers will review the ICH E6 R2 guidelines and provide insights and tips to help map the road to compliance
Speakers Steven Whittaker, Executive Director, Avoca Quality Consortium, Senior Consultant, The Avoca Group
Ellen Kelso, Senior Consultant, The Avoca Group
Kristin Mauri, Global Head – Risk Based Monitoring, Bioclinica
ICH E6 R2 - Guidance and road map of tools for navigating the regulatory landscape Jun 14, 2017

LifeSciences -  The webinar will discuss the implications of the results and highlight key insights for sponsors and CROs to optimize their investigative site management practices
Speakers: Ken Getz, Director of Sponsored Research Programs & Associate Professor, Tufts CSDD
Beth Harper, President, Clinical Performance Partners
Patricia Smith, Business Architect, goBalto
New Tufts CSDD Study on End-to-End Site Identification Through Startup Apr 25, 2017

LifeSciences -  This webinar will discuss noninvasive ways to assess NASH using imaging, including proton density fat fraction (PDFF), T1 relaxometry, Magnetic resonance elastography (MRE) and the latest advances in MRE and how they can be used to assess inflammation.
Speakers: Richard L. Ehman, M.D., Professor of Radiology, Blanche R. & Richard J. Erlanger Professor of Medical Research, Mayo Clinic; President and CEO, Resoundant, Inc.
Jonathan Riek, Vice President, Ph.D., Musculoskeletal and Metabolic Imaging, BioTelemetry Research (Cardiocore & VirtualScopics)
Assessing NASH: Discover the Non-invasive Techniques Apr 13, 2017

LifeSciences - This webinar will take an in-depth look at CRO oversight and risk management best practice, delving into the gaps in oversight processes, the causes of these gaps and how to successfully address them
Speakers: Julie Peacock, Client Services, Comprehend
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)
Critical CRO Oversight Metrics: How to Establish the Right Metrics and Monitor them in Real-time Apr 12, 2017

LifeSciences -  In this webinar, the speakers will discuss their experience with the regulatory and product development processes for combination products to show you how to navigate regulatory complexities
Speakers: Diane Beatty, PhD, Managing Director, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences
Jean Dehdashti, MSc, RAC, Scientist III, Regulatory Affairs & Product Development, Cardinal Health Regulatory Sciences
Combination Product Regulatory Requirement Complexities and the Impact of the 21st Century Cures Act Apr 5, 2017

LifeSciences -  Join the speakers to learn about the best practices for developing a comprehensive health economic and epidemiologic evidence strategy and evidence generation plan that is targeted to meet the needs of regulators and payers
Speakers: Michael Cook, MSc, MSPH, PhD, Principal, Epidemiology, ICON Commercialisation & Outcomes
Dhvani Shah, MS, Lead Health Economist, ICON Commercialisation & Outcomes
Optimise A Strategy Evidence Epidemiologic & Economic Health Comprehensive a with Submissions HTA Regulatory Your Apr 5, 2017

LifeSciences - Join the speaker as he discusses a layered and holistic approach to brand protection. This webinar topic includes serialization, as well as additional measures that can be taken through global inspectors, overt and covert packaging modifications, and an emerging ability for authentication using cloud technologies and smart devices.
Speaker: Jim Sinisgalli, Director of Product Management and Brand Protection, Systech
Will Serialization Compliance Alone Protect Your Brand? Mar 22, 2017

LifeSciences - This webinar follows a previous session from December 2016 on preparing for ICH-GCP E6(R2) at investigator sites by addressing questions practitioners now have as they prepare for future GCP audits and inspections conducted in accordance with these revised guidelines
Speakers: Andrew Mitchell, Director of Life Sciences, Intralinks
Dan Sfera, The Clinical Trials Guru
Gunnar Danielsson, DGD Consulting
ICH-GCP E6(R2) – Live Q&A with GCP Inspector and Investigator Site Perspectives Mar 15, 2017

LifeSciences - This webinar will address the necessity of serialization from market compliance to business supply, covering all aspects from line choice and regulation approach to management of data and related products
Speaker: Mario R. Scigliano, Serialization & Automation Manager, Corden Pharma Latina S.p.A.
From Market Compliance to Business Supply: The Necessity For Serialization Mar 8, 2017

LifeSciences - This talk will focus on various aspects of designing and conducting clinical trials for submission to the FDA, as well as, communicating with FDA during the pre-submission and submission process
Speaker: Richard Kotz, Senior Medical Research Scientist, Biostatistics, NAMSA
Designing an Effective Clinical Trial Mar 7, 2017

LifeSciences - New regulatory pathways and processes are expediting the translation of novel therapies to the bedside, and understanding these options helps ensure availability of more new treatments while minimizing delays
Speakers: Peter Larson, Senior Medical Director, Hematology-Oncology, Premier Research
Colin Hayward, Chief Medical Officer, Premier Research
From Laboratory to Bedside: Expediting Development of Novel Rare Cancer Treatments Feb 28, 2017

LifeSciences - This webinar will explore the development process, the changing regulatory environment, and the device approval pathways to help sponsors optimize the likelihood of regulatory and commercial success
Speakers: Joanne Emmett, Vice President, Medical Device & Diagnostics, Premier Research
Lisa Pitt, Vice President, Global Regulatory Affairs, Premier Research
Medical Device Regulation: Finding Your Path to Success Feb 14, 2017

LifeSciences - In this webinar, the speaker will examine the requirements listed in MEDDEV 2.7/1 revision. 4, discuss notable changes from MEDDEV 2.7/1 revision 3, while focusing on the global benefits of the Clinical Evaluation Report for your product’s path to market
Speaker: Vincent Legay, Manager Europe, Consulting Services, NAMSA
Clinical Evaluation Reports (CERS): Global Benefits & The Impact of MEDDEV Updates to Manufacturers Feb 8, 2017

LifeSciences - This webinar will focus on how Investigator Sites are preparing for ICH-GCP E6(R2) and its impact on remote monitoring
Speakers: Andrew Mitchell, Senior Life Sciences Executive, Intralinks
Dan Sfera The Clinical Trials Guru
Remote Monitoring and Preparing for ICH-GCP E6(R2) at Investigator Sites Dec 13, 2016

LifeSciences -  This webinar will address emerging trends in clinical trial methodology for orphan disease drug development
Speakers from Worldwide Clinical Trials:
Michael Murphy, MD, PhD, Chief Medical and Scientific Officer
Josie Measures, Vice President Biostatistical Operations
Lorna Graham, BSc, MSc, Associate Director, Project Management, Evidence
Barbara Zupancic, Director, Global Patient Recruitment and Retention
Necessity is the Mother of Invention: The Impetus for Observational Research in Orphan Drug Development Dec 7, 2016

LifeSciences -  Viewers will learn about best practices for personalized neoantigen vaccine development
Speakers: Erin Newburn, MS, PhD, Manager, Field Application Scientist, Personalis, Inc.
Christelle Johnson, MS, PhD, Field Application Scientist, Personalis, Inc.
Shifting the Cancer Vaccine Paradigm: NGS Best Practices for Developing Personalized Neoantigen Vaccines Nov 15, 2016

LifeSciences - This webinar will discuss the collection of E/L data that are useful and relevant to risk assessment
Kevin Connor, Ph.D., DABT,, Study Director, Toxikon Corporation
Toxicological Risk Assessment Based on Extractable/Leachable (E/L) Data: Benefits and Limitations Nov 9, 2016

LifeSciences - This webinar will examine what it takes to manage multi-protocol programs and deliver consistent results
Speaker: Svetlana Kolchinsky, Director, Project Operations, BioTelemetry Research (Cardiocore & VirtualScopics)
Managing Multi-Protocol Programs & Building Efficient Partnerships Nov 3, 2016

LifeSciences - Learn how clinical supplies professionals are working behind the scenes to bring these complex devices through clinical development
Speakers: Shawn Regits, Process Engineering Manager, Fisher Clinical Services
Guido Hunkeler, Director Engineering & Automation, Fisher Clinical Services
Key Tips to Sharpen Your Clinical Trial Packaging Strategy for Prefilled Syringes Nov 3, 2016

LifeSciences -  Topics include scientific and clinical research insights on the principles of BOLD fMRI and its application as a clinical tool and drug development biomarker, design of an fMRI study, and an overview of the challenges and limitations of performing fMRI evaluation under an Investigational New Drug Application for drug development
Speakers: Maria Laura Blefari, PhD, Biomedical Engineer, WorldCare Clinical
Mykol Larvie, MD, PhD, Physician, Department of Radiology, Director of Molecular Neuroimaging, Massachusetts General Hospital
Functional Brain Imaging Using MRI: An Emerging Tool for Drug Development and Clinical Trials Oct 28, 2016

LifeSciences -  This webinar will showcase the results of Comprehend’s 2016 ClinOps ICH E6(R2) survey and its impact on the CRO/Sponsor relationship
Speakers: Bruno Gagnon, B Pharm, MSc, Clinical Intelligence Expert
Matt McKinney, Clinical Intelligence Expert, Comprehend Systems
ICH E6(R2) Benchmark Survey: Essential Elements of Compliant CRO Oversight Oct 27, 2016

LifeSciences - Pharmaceutical and life sciences companies are under constant pressure to increase efficiencies, bring new products to the market faster, reduce prices, deliver innovation, ensure patient compliance, and maintain business compliance. In this webinar, Esko will present 6 examples of what good looks like in the world of pharma packaging and labeling management.
Speaker: Mike Baird, Global Business Development - Pharma & Life Sciences, Esko
Packaging and Labeling Management Best Practices in Pharma Oct 27, 2016

LifeSciences -  This webinar will assist medical device designers and manufacturers navigate the reprocessing requirements and successfully execute a manual cleaning validation
Speaker: Michael Brady, MS, PhD , Director of Microbiology Services, Toxikon Corporation
Reprocessing Medical Devices: Approaches and Considerations for Manual Cleaning Validations Oct 26, 2016

LifeSciences - This webinar discusses developing a methodology and minimum standards for migrating instruments that would be applicable to any device
Speakers: Dr. Wilhelm Muehlhausen, Head of Innovation, ICON
Kai Langel, Director Patient Solutions, eClinicalHealth
Helen Marson-Smith, Outcomes Researcher, Clinical Outcomes Assessment, ICON
Bring Your Own Device (BYOD) eCOA – Instrument Validation Methodology Oct 26, 2016

LifeSciences -  This webinar will discuss recent technological advances that have illuminated promising new approaches for immunogen design, vaccine delivery and vaccination
Speaker: Christos J. Petropoulos, PhD, Chief Scientific Officer, Monogram Biosciences, and Vice President, LabCorp
Leveraging Technological Advances to Overcome the Challenges of HIV Vaccine Development Oct 20, 2016

LifeSciences -  In this presentation, the speakers will discuss key findings of a customer use case that involved an SSI impact assessment for a chemical and protein substance according to the latest ISO Implementation Guideline (March 2016)
Speakers: Louise Petersen, Senior Consultant and ISO IDMP SME, NNIT
Jacob Ekstrøm, Advanced Business Consultant, Life Sciences Industry, NNIT
Will Your CMC Data be IDMP e-Submission Ready by 2018?
How to Bring Structure to Substance Information by Leveraging ISO 11238 Compliance with NNIT Substance Registration System
Oct 19, 2016

LifeSciences -  This webinar will address the spectrum of immunotherapy development considerations and their implications for drug developers
Speaker: Steven M. Anderson, PhD, Senior Vice President, Chief Scientific Officer, Covance
The Role of Biomarkers and Companion / Complementary Diagnostics in Immuno-Oncology Trials Oct 5, 2016

LifeSciences - The webinar will focus on study startup and discuss best practices for the identification and mitigation of potential risks before they occur
Speakers: Rob Wynden, VP Technology and Engineering, goBalto
Linda Sullivan, Co-Founder and President, Metrics Champion Consortium
Andrea Sim, VP Product, goBalto
Refocusing on Risk Mitigation in Starting Clinical Trials Sep 27, 2016

LifeSciences - The webinar will present conceptual and logistical challenges of both qualitative and quantitative studies to assess the content validity and measurement properties of these PerfO assessments in these patient groups, and the results from these studies
Speakers: Elizabeth (Nicki) Bush, Research Scientist, Eli Lilly and Company
Rachel Ballinger, Lead Outcomes Researcher, ICON
Helen Doll, Senior Principal, Clinical Outcomes Assessments, ICON
Validating Select Physical Performance Outcome (PerfO) Assessments to Support Labelling Claims in the US: Methods and Lessons Learned Sep 21, 2016

LifeSciences - The webinar will examine factors that produce a therapeutic effect which erodes the efficacy signal of a potential treatment, with particular focus on study design considerations, site factors, subject selection and eligibility, and data surveillance
Speakers: Krista Armstrong, PhD, Vice President, Strategic Development, Premier Research
Susan Kozauer, MD, Senior Medical Director, Psychiatry, Premier Research
Conclusive Results: Strategies for Collecting Quality Data in Psychiatric Clinical Trials Sep 20, 2016

LifeSciences - This webinar will give an overview of endpoint assessment as it relates to RECIST, irRC, and clinical benefit in the setting of cancer immunotherapy
Speakers: Klaus Noever, MD, Senior Director of Medical Affairs, WorldCare Clinical, LLC
Ryan J. Sullivan, MD, Assistant in Medicine, MGH Cancer Center, Massachusetts General Hospital, and Assistant Professor, Medicine, Harvard Medical School
Tumor Burden and Clinical Benefit Assessment in Immunotherapy Clinical Trials Sep 19, 2016

LifeSciences - This webinar reviews the history of patient advocacy groups in advancing clinical research and examines the evolution of their role in light of recent and pending legislative and regulatory changes in the United States and European Union
Speakers: Juliet M. Moritz, Executive Director, Strategic Development, Rare Diseases, Premier Research
Susan Stein, MPH, CEO & President, Connexion Healthcare, and Board Member, Global Genes
The Powerful and Evolving Role of Patient Advocacy Groups in Orphan Drug Development Sep 14, 2016

LifeSciences - This session details best practices for onboarding RBM that have been gained through implementation involving smaller and larger BioPharma sponsors and CROs
Speakers: Francois Torche, Chief Executive Officer, CluePoints
Craig Serra, Senior Director, Data Management BPO, Clinical Sciences and Operations, Pfizer
Removing the “Risk” in Risk-Based Monitoring
What We Have Learnt in the Last 4 Years from the Practical Implementation of RBM
Sep 12, 2016

LifeSciences -  The speakers will discuss the growing range of imaging modalities and analysis methods that are available for use in your clinical trials during oncology drug development
Speakers: Polina Voloshko, MD, Chief Medical Officer, BioTelemetry Research (Cardiocore & VirtualScopics)
Edward Ashton, Ph.D, Vice President, Oncology Imaging, BioTelemetry Research (Cardiocore & VirtualScopics)
Advanced Imaging in Oncology Aug 24, 2016

LifeSciences - This session will focus on the keys to finding a good sponsor/CRO match for your clinical research
Speakers: Cassie Jacobson, Clinical Research Strategy Director, 3M, Critical & Chronic Care Solutions Division
Katie Schaaf, Director, Strategic Partnerships, NAMSA
Ensuring a Successful Collaboration between Sponsors and CROs Jul 27, 2016

LifeSciences -  This webinar will explain and provide examples to illustrate the importance of cultural adaptation and the steps in the linguistic validation process
Speakers: Adelina Lear, BA, Strategic Account Executive, ICON Language Services
Diane Wild, MSc, Consultant
Linguistic Validation – When Google Translate Just Isn’t Enough Jul 26, 2016

LifeSciences - In this webinar, the presenter will show how pharmaceutical packaging and labelling complexity occurs, what the consequences are of inaction, most importantly, what pharmaceutical companies can do to reduce and manage the process
Speaker: Mike Baird, Global Business Development - Pharma & Life Sciences, Esko
How to Manage Pharma Packaging Complexity Jul 19, 2016

LifeSciences - Topics include a review of the benefits and considerations related to pursuing accelerated approval, advice on how to access the applicable expedited program, and effectively interact with the Agency, following the regulatory pathway most expeditiously
Robert Millham, MS, MSc, PharmMed, Senior Vice President & General Manager, Hematology & Oncology, inVentiv Health
Carolyn Finkle, MSc, Senior Vice President, Regulatory Affairs, inVentiv Health
Joseph O’Connell, MD, Vice President, Medical & Scientific Affairs, Hematology & Oncology, inVentiv Health
Pursuing Accelerated Approval in Oncology Indications: Is your Asset the Right Candidate? Jun 16, 2016

LifeSciences - With a real-time healthcare system and the use of RFID-enabled solutions, imagine the possibilities that exist when all assets in your healthcare facility are connected
Speakers: Mark Van Sumeren, Managing Director, Health Industry Advisor, LLC
Joe Pleshek, CEO & President, Terso Solutions, Inc.
Improving the Operations and Delivery of Care through the Real-time Healthcare System Jun 9, 2016

LifeSciences - Will remote monitoring create an additional and unnecessary burden of responsibility at the site level, or will it make for a more efficient and profitable workflow dynamic?
Speakers: Andrew Mitchell, Director, Life Sciences Strategy and Product Marketing, Intralinks
Dan Sfera, The Clinical Trials Guru
Reinventing Remote Monitoring: The Implications of Innovation June 7, 2016

LifeSciences - Understanding existing resources, financial aid, and incentives is important for any orphan product developer. This webinar will describe support offerings available through global regulatory agencies and examine pending initiatives affecting orphan drug clinical development.
Speakers: Angi Robinson, Executive Director, Pediatrics and Rare Diseases, Premier Research
Lisa Pitt, Vice President, Global Regulatory Affairs, Premier Research
Juliet M. Moritz, Executive Director, Strategic Development, Rare Diseases, Premier Research<
No Opportunity Unturned: Optimizing Orphan Drug Development June 1, 2016

LifeSciences - The presenters will share guidance as provided in the AMCP Format in regard to special content considerations as well as logistical considerations with regard to AMCP dossiers
Speakers: Evelyn Sarnes, PharmD, MPH, Senior Director Medical Communications, Xcenda
Kim Boswell, MD, Director, Medical Communications, Xcenda
Academy of Managed Care Pharmacy (AMCP) Format Update, Version 4.0: Practical Implications for AMCP Dossiers May 26, 2016

LifeSciences - This webinar, featuring a panel of experts from LZ Lifescience and FDA consultant Robert Lewis of IHL Consulting, aims to help life science companies reduce the risk of getting 483 observations and warning letters in 2016 and beyond Mitigate the Risk of Receiving FDA 483 Observations, Leading to Warning Letters – Your Guide to a Preventative Approach May 24 2016

LifeSciences - The presenters will discuss the opportunities and challenges and provide tips on how to achieve success in running biosimilar clinical trials
Speakers: Dan Ramos, North America Customer Liason, Fisher Clinical Services
Khaled ElGendy, Associate Director – Head Comparator, Fisher Clinical Services
Biosimilars in Clinical Trials: Smart Reference Drug Sourcing and Advanced Blinding Techniques May 17, 2016

LifeSciences - Join this webinar and consider the potential of collaborative partnerships between academicians, clinical investigators and contract research organizations in delivering new therapies for patients with diabetic nephropathy
Speakers: George L. Bakris , MD, Hon. DSc, F.A.S.H, F.A.S.N., F.A.H.A., Professor of Medicine, Director, ASH Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, IL
Michael D. Cressman, D.O., Senior Medical Director, Covance
Jennifer Ennis, MD, Medical Director, Litholink Corporation, A LabCorp Company
Applying Advanced Informatics to Accelerate Drug Development in Diabetic Nephropathy May 6, 2016

LifeSciences - Understanding and mastering the FDA's Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling is the first step in getting new, reusable devices into the US marketplace
Speaker: Steven Elliott, Director, Quality Control and Sterility Assurance, NAMSA
Reusable Medical Devices – Getting Market Clearance in the United States May 4, 2016

LifeSciences - Tufts CSDD presents the findings of a new study assessing practices and inefficiencies associated with site selection, study startup, and site activation in starting clinical trials
Speakers: Ken Getz, Director of Sponsored Research Programs & Associate Professor, Tufts Center for the Study of Drug Development
Judy Luk-Smit, Director of Product Management, goBalto
Tufts Report & Removing the Blinders in Site Selection Apr 26, 2016

LifeSciences - This webinar will help viewers understand better the industry’s current inspection challenges and for a demo of a pioneering fully integrated label management software solution with a print inspection hardware
Speakers: Warren Stacey, SVP of Sales, PRISYM ID
Phil Dray, Senior Test and Validation Engineer, PRISYM ID
Craig Jones, VP Enterprise Sales Engineering, PRISYM ID
Medical Device Labels: Using Integrated Vision to Achieve 100% FDA Compliance Apr 6, 2016

LifeSciences - There are two major categories of safety monitoring: “Clinical” which refers to safety monitoring of clinical trials and “Post-marketing”, safety monitoring of situations following approval and marketing, other than directly associated with clinical trials
Speaker: Margaret McCulloch, M.D. , Medical Doctor, Ashfield Pharmacovigilance
The Differences Between Clinical and Post Market Medical Reviews Mar 30, 2016

LifeSciences - This webinar will highlight some of the challenges in designing and conducting trials for rare cancers and explore positions adopted by various authors and research consortia on how to best design and conduct these trials, including a review of pending legislation — the 21st Century Cures Act — and how it might affect rare oncology research if passed
Speakers: Sachin Kulkarni, Executive Director, Strategic Development, Oncology & General Medicine, Premier Research
Juliet M. Moritz, Executive Director, Strategic Development, Rare Diseases, Premier Research
Rare Oncology Research in the 21st Century Mar 29, 2016

LifeSciences - This webinar will focus on what’s known about the proposed Medicare Part B drug payment model and what the implications are for pharmaceutical manufacturers
Speakers: Amanda Forys, MSPH, Director, Reimbursement Policy Insights, Xcenda
Jennifer Snow, MPH, Director of Health Policy, Xcenda
Part B Drug Payment Change: Understanding the Implications for Pharma Mar 28, 2016

LifeSciences - This presentation will focus on spray drying process development and will cover spray-drying equipment and scale-up of from the bench to pilot scale
Speaker: Jon Scrafford, Manager, Process Engineering, Pharmatek
Spray Dried Dispersion Process Development Mar, 10, 2016

LifeSciences - Topics include data driven formulation development and spray dried dispersions formulation development for early phase clinical studies
Speakers: Bryan Knox, Senior Director of Pharmaceutics, Pharmatek
Nathan Barksdale, Senior Scientist, Pharmatek
Product Development Strategies for Poorly Soluble Compounds Mar 3, 2016

LifeSciences - The speaker will examine the requirements listed in MEDDEV 2.7.1 rev. 3 while focusing on the global benefits of the Clinical Evaluation report for an individual's product’s path to market
Speaker: Sandra Welch, Director of Clinical Research Services, NAMSA
The Global Value for Clinical Evaluation Reports in Medical Device Studies Feb 29, 2016

LifeSciences - The presentation will help clinical operations teams navigate through two new 2016 regulatory imperatives, including clinical supply specific rules in the European Union and a new inspection strategy from the U.S. Food and Drug Administration
Speakers: Harry Berlanga, Lead Qualified Person (QP), Fisher Clinical Services
Maria Matos, DEA and Licenses Manager, Fisher Clinical Services
Asiya Imam, Director of Quality Assurance, Fisher Clinical Services
Regulatory Readiness for Clinical Trial Supplies Feb 23, 2016

LifeSciences - The speakers will discuss examples, implementation, features and benefits of an integrated approach to reduce recalls from pharmaceutical packaging errors
Speakers: Mike Baird, Global Business Development - Pharma & Life Sciences, Esko
Arpad Lehoczki, Senior Account Executive, Global Vision
Minimize the Risk of Recalls - The Cost of Poor Pharmaceutical Packaging Management Feb 18, 2016

LifeSciences - This presentation will discuss the three sins and provide absolution methods on how to be a successful GMP Executive
Speaker: Troy Fugate, Vice President, Compliance Insight, Inc.
The Three Sins of GMP Executives Jan 27, 2016

LifeSciences - As the globalization of clinical research gathers pace, the Asian region will continue to grow, making it the most exciting frontier for biopharma companies conducting clinical research
Speakers: Dr. John Moller, Chief Operating Officer - Asia, Novotech
Kim Wong, Head of Regulatory Affairs, Novotech
Chayanontchaimongkol Boonchaliew, Clinical Operations Manager - Thailand, Novotech
Clinical Trial Planning in Asia: A Roadmap for Biotech Sponsors Jan 22, 2016

LifeSciences - Learn from two market leaders about an optimal way to get actionable results from the comprehensive analysis of clinical and operational data
Speakers: James Streeter, Senior Director of Life Sciences Product Strategy, Oracle Health Sciences
Francois Torche, CEO and Chief Information Officer, CluePoints
The Complete Integrated Risk-Based Monitoring (RBM) Solution:
Harnessing the Power of Multiple Technology Systems to Drive RBM and Overall Data Quality Oversight
Jan 21, 2016

LifeSciences - This webinar will examine the opportunities for improvement introduced by RBM invite evaluation of a new pattern of interaction between clinical development teams and ERBs, and provide recommendations to industry, ERBs and other stakeholders
Speakers: Andy Lawton, Global Head, Biometrics and Data Management, Boehringer Ingelheim Ltd.
Ellen Kelso, Executive Director Strategic Development, Chesapeake IRB
Risk-Based Monitoring and The IRB: Convergence and Opportunities Dec 17, 2015

LifeSciences - Opening sites in countries where clinical trials are uncommon requires detailed knowledge of the host countries and the complex regulations they may impose, along with thorough site training in protocol and good clinical practices
Speakers: Alison Sampson, Senior Project Director, Premier Research
Hanna Wide, MSc, Project Manager, Premier Research
Rare Disease Research: Conducting Clinical Trials Where the Patients Are Dec 15, 2015

LifeSciences - This discussion is built around the most pressing issues affecting the Compounding Pharmacy/ Outsourcing Industry
Speaker: Doyle Smith, Compliance Specialist, Compliance Insight, Inc.
FDA Expectations for 503B Outsourcing Facilities Dec 11, 2015

LifeSciences/Food Safety - The webinar will cover what you need to know and should be doing now to ensure your food defense plan is FSMA proof
Speakers: Don Hsieh, Director of Commercial and Industrial Marketing, Tyco Integrated Security
Ned Mitenius, Founder and President, Periscope Consulting, LLC
Food Defense Vulnerability Assessment: 3 Things You Need to Know to Prepare for the Food Safety Modernization Act (FSMA) Dec 10, 2015

LifeSciences - The purpose of this webinar is to simplify the regulatory submission process, which is a source of difficulty largely unmitigated by available technologies today
Speaker: Patrick Smith, Technical Marketing Writer, DATATRAK
Simplifying the Clinical Trial Regulatory Submission Process Dec 9, 2015

LifeSciences - This webinar will provide a unique insight into human abuse potential studies and their diverse challenges, notably from the perspective of the study subject.
Speakers: Dr. Beatrice Setnik, Vice President, Clinical Pharmacology, Early Phase, INC Research
Dr. Pierre Geoffroy, Vice President, Early Phase, INC Research
Clinical Challenges in the Abuse Potential Assessment of CNS-Active Drugs: Investigator Perspectives with a Special Commentary from a Study Volunteer Dec 9, 2015

LifeSciences - This webinar will present a bird’s eye view highlighting a Phase I study with mid-level complexities and showcase lessons learned from the speakers' experiences, highlighting how building the database structure utilizing CDASH standards minimizes the gap with SDTM format
Speakers: Jonathan Zimmerman, Senior Clinical Data Manager, FMD K&L Inc.
Yuguang Zhao, MS, Vice President, Statistical Programming, FMD K&L Inc.
Utilizing a Collaborative Approach to Create Efficiencies with CDISC – CDASH Standards Nov 19, 2015

LifeSciences - In adaptive design trials, the importance of careful design, meticulous planning, and rigorous ethical review cannot be overemphasized
Speakers: Thomas Laage, MD, MPH, Director, Product Development Consulting and Regulatory Medical Writing Support, Premier Research
Jennifer Nezzer, Director of Biostatistics, Premier Research
Ethical Considerations in Adaptive Design Clinical Trials Nov 19, 2015

LifeSciences - Industry leaders are now adopting ‘best of breed’ applications in the eClinical stack to speed the development of needed therapies to patients
Speakers: Vittoria Sparacio, Head of Clinical Documentation, GSK Pharmaceuticals
Scott McCulloch, Principal Consultant, SMClinical Limited
Barry Milton, Director of Client Engagement, goBalto
Ready to Start Your Clinical Trial? Think Again. Nov 16, 2015

LifeSciences - Premier Research has developed a proprietary Pediatric Certificate Training Program to train our employees on core competencies and considerations in the development and conduct of pediatric studies
Speakers: Alison Sampson, Senior Project Director, Premier Research
Susan P. Tansey, MD, Medical Director, Paediatrics, Premier Research
Pediatric Trial Certification: A Platform for Success Nov 9, 2015

LifeSciences - This webinar will provide an overview of the independent endpoint adjudication process with a focus on understanding what is necessary to operationalize an endpoint committee
Speakers: Richard Walovitch, PhD, President, WorldCare Clinical
Glenn Bubley, MD, Director of Genitourinary Medical Oncology, Beth Israel Deaconess Medical Center
An Overview and Guide to Clinical Trial Endpoint Adjudication Nov 9, 2015

LifeSciences - This webinar will review the ISPOR guidance in relation to changes over the past 10 years in the COA environment and describe some of the current issues, methodological challenges and solutions in this ever changing field
Speakers: Helen Anderson, DPhil, Manager, ICON Language Services
Diane Wild, MSc, Consultant
Linguistic Validation of Clinical Outcomes Assessments (COAs) and Electronic Clinical Outcomes Assessments (eCOA) Nov 3, 2015

LifeSciences - This webinar will reveal some of the concerns that clinical study sites have regarding risk-based monitoring, including impacts to workload, budgets and monitoring support
Speaker: Bob Bois, Director, Clinical Innovation, INC Research
Risk-Based Monitoring: What Does it Mean for Clinical Study Sites? Oct 22, 2015


LifeSciences - Discussion of what it takes to build and manage an effective Global CDx Program, designed to maximize the chance of a successful, coordinated launch of a therapeutic and companion assay world-wide
Speakers: Austin C. Speier, Director, Emerging Technologies and Markets, Precision for Medicine
Judi Smith, MS, MT(ASCP), Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine
Developing an Effective Global Companion Diagnostic Regulatory Strategy Oct 19, 2015

LifeSciences - This webinar will explore what’s happening in the payer space today, the impetus for this change, and the potential outlook of the health insurance landscape in the future
Speakers: Cathy Carroll, PhD, MA, MBA, BSPharm, Senior Director of Managed Markets/Market Access, Commercial Consulting, Xcenda
Nina Ohara, PharmD, MBA, MS, RPh, Director, Commercial Client Strategy Team, Xcenda
Insurance Megamergers: How Will They Impact Manufacturers’ Commercialization Strategy? Oct 15, 2015

LifeSciences - This presentation is designed to detail the similarities and differences between GMP controls for Rx and OTC products
Speaker: Eileen C. Nieto, CQA, Compliance Specialist, Compliance Insight, Inc.
Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions Oct 14, 2015

LifeSciences - Examples of signal detection through a multi-tiered approach will be provided, the roles of key players in the process will be introduced and the speaker will explore how the outcomes of signal detection and tending influence Benefit Risk assessments
Speaker: Robin Williams, B.S., CMC, Senior Safety Scientist, Drug Safety Alliance / Ashfield Pharmacovigilance
Insight into Detection & Management of Safety Signals Oct 9, 2015

LifeSciences - The speaker will discuss the regulation of colorants in medical devices and present solutions to many of these challenges, therefore preparing you for the attainment of a successful regulatory submission
Speaker: John Iannone, Program Manager/Technical Specialist, Extractables/Leachables & Special Studies, Toxikon Corporation
Colorants in Devices: Successfully Integrated Strategies towards Regulatory Approval Oct 6, 2015

LifeSciences - This program will provide an important overview of the impacts and issues involved in leveraging the IoT within healthcare and clinical research in particular
Speakers: Eric Meslin, PhD, Director of the Indiana University Center for Bioethics, Dean for Bioethics, Indiana University School of Medicine
Jennifer Covich Bordenick, Co-Chair of the Federal HIT Policy Committee’s Strategy and Innovation Workgroup, CEO of eHealth Initiative
Marvin Slepian, MD, Co-Founder and Chief Scientific Officer of SynCardia Systems Inc., Founder and Director of The Arizona Center for Accelerated Biomedical Innovation
Megan Doerr, MS, CGC, Principal Scientist, Governance Team, Sage Bionetworks
Ellen Kelso, Executive Director Strategic Development, ChesapeakeIRB
The "Internet of Things" and Clinical Research: Privacy, Security, and Ethical Aspects Sept 28, 2015

LifeSciences - This webinar will focus on two important aspects of Data Monitoring Committees: Set-up and communications
Speakers: Angela McPartlane, Associate Director of the DMC Unit, PRA Health Sciences
Andrew Mitchell, Director, Life Sciences Strategy and Product Marketing, Intralinks
Data Monitoring Committees: Simple Solutions for Critical Issues Sept 25, 2015

LifeSciences - The speaker will share ideas and practical examples on innovative approaches to antibacterial discovery to meet the augmented needs of the market and to tackle antibacterial resistance issues
Speakers: Beth A. Lage, RAC,, Associate Director of Strategic Global Labeling for Medical Products, Baxter Healthcare Corporation
Griha L. Mangru, Labeling Strategist, Global Labeling Management Team, Pfizer
Boris Jankowski, Director of Solutions Architecture, Sciformix
Craig Trautman, CEO, Intagras
Optimizing Your Global Labeling Operations: An Expert Panel Discussion Sept 22, 2015


LifeSciences - In this session, specific case study examples will be used to explore all these key topics. Learn best practices for site selection, including the possible need to over recruit sites for Phase IV trials
Speaker: Alexandra Adams, Ph.D Dip.Clin.Sci. Hon FICR, Director, Late Phase, Chiltern
Best Practice Approaches in Executing Post Approval Programs Sept 17, 2015


LifeSciences - This presentation on the new EU clinical trials regulation will identify what’s happening with the regulation that governs clinical trials in Europe
Speaker: Dr. Martine Dehlinger-Kremer, Global VP, Medical and Regulatory Affairs, SynteractHCR
The New EU Clinical Trials Regulation: What You Need to Know Before 2016 Jul 23, 2015

LifeSciences - In this webinar, the successful development and commercialization of companion diagnostics (CDx) will be discussed by experts from Covance and LabCorp.
Speakers: Mark Roberts, Ph.D., Director of Diagnostics Development, Covance
Alan Wookey, Associate Vice President and Executive Director of Companion Diagnostics, Covance
Pathway Considerations to CDx Development and Commercialization Jun 30, 2015


LifeSciences - This free webinar aims to describe novel medical imaging approaches and methodologies to help sponsors maximize clinical trial efficiency along the development pathway.
Speakers: Sandra Chica, MD, VP of Medical Imaging, BioTelemetry Inc.
Polina Voloshko, MD, Chief Medical Officer, BioTelemetry Research
Medical Imaging: Maximizing Efficacy and Safety in Oncology Clinical Trials Jun 24, 2015


LifeSciences - In this free webinar, the speakers will explore what we believe are the driving factors of change toward that future, hoping that it will be suitable to a broad audience of stakeholders in cancer clinical trials.
Speakers: Dr. Jay Herson, Senior Associate, Biostatistics, Johns Hopkins University Baltimore, Maryland USA
Dr. Everardo Saad, Senior Medical Expert, IDDI
What is the Future of Cancer Clinical Trials? Jun 22, 2015


LifeSciences - This webinar aims to help attendees understand the epidemiology and health burden of Non-Alcoholic Steatohepatitis and present contemporary information on new preclinical models that can support drug development for NASH.
Speakers: Claudia Filozof, MD, PhD, Senior Medical Director, Cardiovascular/Metabolic, Covance
Arun Sanyal, MD, Executive Director, Education Core, Center for Clinical and Translational Research, Virginia Commonwealth University
Richard Williams, PhD, JD, Senior Director, Global Regulatory Strategy, Covance
Non-Alcoholic Steatohepatitis (NASH): Preclinical and Clinical Development and Progress Toward Regulatory Approval Pathways Jun 17, 2015
LifeSciences - The speaker will discuss clinical supply strategies for Investigator Initiated Trials, including an extensive analysis of the study protocols
Speaker: Helen Underwood, Director of Strategic Customer Relationships, Fisher Clinical Services
How Clinical Supply Teams can Respond to the Growth in Investigator Initiated Trials Jun 9, 2015
LifeSciences - Several key factors have conspired against RBM progress, however the speakers, both industry and RBM experts, will share their insights on RBM keys to success
Speakers: Steve Young, Senior Director of Transformation Services, OmniComm Systems, Inc.
Andy Lawton, Global Head of Clinical Data Management, Boehringer Ingelheim
Ensuring RBM Success – Keep it Simple! Jun 5, 2015
LifeSciences - The speakers will discuss replacing manual paper-based procedures and implementing secure offsite document access and management
Speakers: Andrew Mitchell, Director, Life Sciences Strategy and Product Marketing, Intralinks
Kathie Clark, Vice President of Product Management, Wingspan Technology
Closing the Loop: eTMF and eISF Reduce Paper and Support Remote Monitoring May 21, 2015
LifeSciences - This presentation focuses on the regulatory aspects of bringing therapies for rare diseases to the market
Speakers: Nach Dave, Director, Regulatory Affairs, Premier Research
Carol Huntington, Associate Director, Regulatory Affairs Europe, Premier Research
Orphan Drug & Rare Disease Development: Understanding the European and US Regulatory Landscape May 19, 2015
LifeSciences - During this webinar, the speakers will explore the challenges, business justification, and approach to EDC Rescue Studies and Clinical Data Migration
Speakers: Ken Light, EVP of Transformation and Professional Services, OmniComm Systems, Inc.
Rob Mangold, Sr. Director of Client Services, OmniComm Systems, Inc.
EDC Rescue Studies & Clinical Data Migrations – Challenges, Business Justification, and Approach May 12, 2015
Life Sciences - This webinar will deliver key considerations and imperative questions you must ask of any cloud services provider to ensure the offering can satisfy key requirements of 21 CFR Part 11, as well as cover essential questions to ask during the vendor audit of a cloud provider
Speaker: Matt Walz, B.S., M.B.A., Chief Strategy Officer, NextDocs Corporation
FDA Compliant Systems in the Cloud: Five Requirements You Must Satisfy! May 7, 2015
The speakers will discuss strategies for maximizing the value vigilance of your established product
Speakers: Matthew McKeever, M.D., FAAP, VP and Global Head, Safety Knowledge and Reporting, Medical Safety, Aggregate Reporting, Benefit Risk Management and Regulatory Reporting, Quintiles
James C. Walker, CEO and Founder, Octagon Research Solutions, Inc.
Value Vigilance: A Transformative Approach to Managing Safety and Regulatory for Established Products Apr 2, 2015
This webinar attempts to highlight the last development of REACH including testing strategy and tips and tricks to more efficiently and successfully use QSAR and read across in REACH registrations
Speakers: Erwin Annys, Director REACH/Chemicals Policy, CEFIC
Marie-Elène Boivin, Head of Regulatory Affairs, WIL Research
Tatiana Netzeva, Senior Scientific Officer, Computational Assessment and Dissemination Unit, ECHA
REACH: Suggestions, Tips and Tricks for Effective Testing Strategies Oct 15/14
This discussion will focus on the primary CMC requirements for a biopharmaceutical IND submission
Speaker: Glenn E. Petrie, Ph.D., Senior Scientific Advisor, ABC Laboratories
The Critical Role of CMC in Your IND Submission Oct 15/14
Join the presenter for insight on the current German requirements, recent trends in price negotiations, and future direction for the AMNOG assessment
Speaker: Thomas Mittendorf, MBA, PhD, Vice President and Managing Director, Herescon GmbH, an AmerisourceBergen company
AMNOG – German Regulation in the Past, Present and Future Sep 17/14
This webinar will examine strategies, processes, and technology to help maximize productivity and reduce cycle times
Speakers: Mark Thomson, MBA, NA Sales & Marketing Manager, Arazy Group Consultants Inc.
John Iannone, Program Manager – Extractables/Leachables & Special Studies, Toxikon Corporation
Colorants in Devices: Integrated Strategies Toward Regulatory Approval July 8/14
In this webinar, you will learn what an employer can do with baseline testing
Speaker: MaryRose Cusimano-Reaston, Ph.D., Founder and Chief Science Officer, Emerge Diagnostics
The Sunshine Act: CMS Mandatory Reporting Requirements and Baseline Testing

Mar 12/14

The Sunshine Act compliance requirements in the context of the present regulatory environment, enforcement, penalties for failure to comply, and potential unintended consequences, both good and bad, will be discussed
Speakers: Gary Yingling, BS, MS, JD., Partner, Morgan Lewis, Washington DC
The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? Jan 29/14
This program will present a systematic approach to the risk assessment of clinical trials, using methodologies that have been accepted by regulatory authorities as the basis for approvals in other healthcare categories and in other industries
Speakers: Michael Macri, Director, Strategic Services, inVentiv Health Clinical
Jeffrey Fetterman, President, ParagonRx International, an inVentiv Health Business
Risk Assessment: Laying the Foundation for RBM Nov 14/13
Learn about the importance of early and careful planning of all activities related to the generation and submission of DSURs, which includes resource planning
Speaker: Sabine Richter, PhD, M.Sc, Vice President Safety and Risk Management PRA
Challenges with Planning and Generation of Development Safety Update Reports (DSURs) and How to Overcome Them Nov 13/13
In this webinar, an overview of the market environment along with the key operational, logistical, and regulatory aspects of conducting clinical trials in China and other Asian countries will be discussed
Speakers: Li Yan, MD, PhD, Executive Director of Clinical Development for Infectious Diseases, Oncology, Respiratory & Immunology, and Vaccines in Emerging Markets, Merck
Patrice Hugo, PhD, Chief Scientist, LabCorp Clinical Trials
Current Trends for Conducting Clinical Trials in China Nov 12/13
Join our speakers for an in-depth look at challenges and proven strategies to develop and implement post-approval risk management procedures
Speakers: Mazhar Thakur, MD, MBA, MAMM, Senior Director, Safety and Risk Management, PRA
Agnes Rivaille, Scientific Affairs Director, Late Phase Services, PRA
Risk Minimization/Mitigation in the Post-Marketing Arena: Regulatory Landscape, Strategy and Effectiveness Nov 4/13
A discussion of the issues from Health Canada’s perspective as the regulatory agency with the most recent and perhaps progressive guidance in the world on the inclusion of women in clinical trials, plus insights into the practical barriers to overcome, and some strategies that can be successfully employed by sponsors and sites to encourage better engagement and improved recruitment and retention of women in clinical trials, a legal, moral and pragmatic imperative
Speaker: Dr. Agnes Klein, MD, MPH, Director, Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate, Health Canada
Mr. Zach Halinan, Director of Patient Communication and Engagement Programs, Center for Information and Study on Clinical Research Participation
Gender Issues in Clinical Trials: Ethical, Regulatory and Practical Considerations Oct 7/13
The presenters will share their views of the most recent FDA guidance and explain its impact on clinical development
Speakers: Dan White, Vice President, Global Operations, Quintiles
Dan Ballard, Senior Director, Data Quality, Quintiles
FDA Guidance on Risk-based Monitoring while Improving Data Quality Sep 30/13
During this webinar you will learn how planning can help avoid costly delays and quality issues, ultimately saving you time and setting you off on the right path to a successful dossier filing and registration
Speakers: Terry Weber Sosa, Vice President, NAMR Biostatistics, Quintiles
Laurie Henricks, Senior Director, Head of North America Regulatory Affairs, Quintiles
Planning for Success: Early Opportunities to Set the Course for Successful Global Marketing Authorization Sep 26/13
Learn how technology can assist VAMC’s & Hospital’s to not only meet regulatory requirements, but also provide savings and patient safety
Speakers: Alan J. Brander, RN BSN BSW MBA CHE HACP, Vice President of National Sales & Clinical Services, LPIT Solutions
Alisa Riebe, Terso Solutions, Inc.
Using RFID Technology to Compliantly Track Tissue and Implants Aug 22/13
This webinar will focus on the regulatory requirements and expectancies for the conduct of studies to support the scheduling of new chemical entities
Speaker: Mary Jeanne Kallman, Ph.D., Director of Nonclinical Neuroscience, Covance
Addressing Scientific and Regulatory Challenges for Abuse Liability Studies Jul 26/13
The webinar will review the current regulatory landscape and guidance for nonclinical and clinical development of biosimilars with a focus on safety-related aspects and discuss the current challenges and future perspectives in this area
Speaker: Joerg Bluemel, Director Toxicology within Biologics Safety Assessment / Translational Sciences, MedImmune, Gaithersburg MD

Nonclinical and Clinical Safety Assessment of Biosimilars: Status and Perspective

Jul 25/13

This webinar will explore the roles of DSMBs and IRBs in particular and examine how they are involved in ensuring patient safety in pediatric trials, the unique considerations in developing DSMBs for pediatric populations, how regulatory guidance is driving change for DSMBs and IRBs and how to best work with each other and sponsors to ensure the highest degree of safety for patients and the best quality of research and data
Speakers: Jeffrey Cooper: Vice President Global Consulting at WIRB Copernicus Group IRB
Amy Professor Philip Walson, MD Board Certified in Paediatrics, Clinical Pharmacology and Medical Toxicology; Visiting Professor, Department of Laboratory Medicine at Georg-August-University Medical School, Germany
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
Pediatric Safety Monitoring: Role of IRBs and DSMBs Jul 18/13
Learn about the hurdles to overcome when studying rare diseases and find out how to skillfully navigate the clinical and regulatory challenges on the path to successful orphan drug development
Speakers: Angi Robinson, Executive Director, Scientific Account Leader, Premier Research
Charlene Sanders, Vice President, Global Regulatory Affairs & Pediatric Strategic Consulting, Premier Research
Strategies for Rare Disease Studies and Orphan Drug Development in the US Jul 16/13
This webinar will discuss approaches used at Bend Research to design, assay, and manufacture spray-dried powder formulations containing proteins and nucleic acids
Speakers: Jeff Breit, Ph.D., Director of Inhalation Technology, Bend Research Inc.
Devon DuBose, Senior Research Engineer, Bend Research Inc.
Vaccine and Biotherapeutic Formulation Development and Manufacture Using Spray-Drying Jul 10/13
This webinar will encompass the three key steps that maximize cross-cultural equivalence of scales assessing patient benefit and safety in international research
Speakers: Benoit Arnould, PhD, Senior Director, Mapi
Nicola Germain, MA, Senior Research Associate, Mapi
Managing Cultural Variability in PRO Measurement in Global Clinical Research
Part 1: Cross-cultural Qualitative Research for Simultaneous Scale Development
Jul 2/13
This presentation will examine recent changes in Indian clinical trial regulations, iImmediate and long term impacts, an foreseeable opportunities
Speaker: Dr. Josemund Menezes, MBBS, Regional Director, Clinical Development (Asia-Pacific), Sanofi Pasteur

Adhering Navigating the Dynamic Indian Clinical Trial Landscape

Jun 28/13

This webinar will examine the need for more oversight in pharmaceutical advertising and promotion, and review the basic regulations and guiding principles
Speaker: Moulakshi (Mou) Roychowdhury, PharmD, JD, Director of Regulatory Affairs – Global Advertising & Labeling, Forest Laboratories

Drug Advertising and Promotion Labeling: FDA Regulations

Jun 21/13

In this webinar the issue of adherence to asthma medication in both clinical trials and the real world will be explored, including measurement of adherence, data interpretation, regulatory implications, and the challenges of generalizing study data to routine clinical practice
Speakers: Liam Heaney, Clinical Professor and Consultant, Queen's University. Belfast, UK
Peter Summerfield, VP, Global TAH Respiratory, Global Product Development, PPD
Rav Seeruthun, MRCGP, MFPM, Senior Director, Global Late Stage Research, PPD
Adherence in Asthma: Comparing Clinical Trials to the "Real-World" Jun 14/13
This webinar will discuss the new European Union (EU) Pharmacovigilance legislation to ensure compliance and evaluate the optimal risk management plan (RMP) and Risk Evaluation and Risk Evaluation and Mitigation Strategies (REMS) for EU and US submissions
Speaker: Amy Sun MD, Ph.D., FACP, Director of Clinical Risk Management, Merck

Drug Safety & Risk Management

Jun 14/13

A discussion of the clinical research scenario in S.E. Asia including market opportunity, registration, new regulatory and safety guidelines
Speakers: Dr. Shariq Anwar, Head of Operations, Max Neeman International
Donald Swankie, MBA, Vice President, USA, Max Neeman International
S.E. Asia Drug/Device Update: Market Potential and Regulatory Environment Jun 6/13
LifeSciences An in depth look at release of a draft revision by the European Commission in 2012 that will impact medical device and medical diagnostic manufacturers in the EU and abroad
Speakers: Janette Benaddi, RGN, BSc, MICR, CSci, CDir, MIOD, CEO, Medvance
Marcus Thornton, Senior Director, CTMS, Medidata Solutions
How the Medical Device Industry Can Prepare for the EU Regulatory Changes Ahead May 23/13
LifeSciences Learn about the hurdles to overcome when studying rare diseases and find out how to skillfully navigate the clinical and regulatory challenges on the path to successful orphan drug development
Speakers: Susan Tansey, MD, Medical Director, Paediatrics, Premier Research
Susan Bhatti, PhD, Executive Director European Regulatory Affairs and Medical Writing, Premier Research
Strategies for Rare Disease Studies and Orphan Drug Development in Europe May 14/13
LifeSciences This fourth webinar in our series will focus on the regulatory aspects of conducting clinical trials in Russia
Speakers: Yuri Afonchikov, MD, PhD, Vice President, Regulatory Affairs, Synergy Research Group
Igor Stefanov, Director, General Manager, Synergy Research Group
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 4 - Regulatory Affairs: The Key to Russia
Apr 10/13
LifeSciences The speakers will evaluate the quality of clinical trials being conducted in Russia / Ukraine compared to Western Europe, Eastern Europe and other Emerging Markets based on the results of recent FDA inspections conducted at clinical trial sites in these regions
Speakers: David Passov, MBA Senior Vice President, Eastern Europe, ClinStar, A PRA Company
Stanislav Gneushev, MD, MRQA, Director, Quality Assurance, ClinStar, A PRA Company
An Evaluation of Clinical Trial Quality in Russia / Ukraine Compared to Western Europe, Eastern Europe and Other Emerging Markets Mar 22/13
LifeSciences This webinar will examine highlights of the draft guidance issued in late 2011 by the FDA entitled: “A Risk-based Approach to Monitoring” and will provide examples of potential cost savings and increased efficiencies gained by implementing a risk-based monitoring approach
Speakers: Keith Howells, SVP Development, OmniComm Systems, Inc.
Becky (Causey) Carpenter, VP of Operations, ResearchPoint Global
Challenges and Opportunities in Risk-based Approach to Monitoring Mar 12/13
This presentation will discuss the number of new and diverse items that will be included in the new directive (eg. validation, quality management and risk management). More guidance will be offered for topics such as temperature management and transportation.
Speaker: Riekert Bruinink, Senior GMP/GDP Inspector, Dutch Health Care Inspectorate, The Netherlands

EU Good Distribution Practice Guidelines 2013

Feb 8/13

This webinar will focus on ensuring compliance with international and local country specific PV Requirements from an Asia-Pacific perspective
Speaker: Michal Borawski, International Pharmacovigilance Officer for the Asia-Pacific Region Affairs, Sanofi Pasteur

How to Ensure Pharmacovigilance Practices are Compliant with Global Safety Requirements: Challenges in Asia-Pacific

Jan 30/13

In this presentation, a detailed description of the requirements for registration and post-marketing, as well as a Pharmacovigilance plan will be discussed
Speaker: Vijay Tammara, VP Global Regulatory Affairs, Nuron Biotech, AAPS Member

Biosimilar Regulatory Guidelines in Emerging Markets – India

Jan 24/13

LifeSciences Dr. Klein will discuss Health Canada’s approach and stringent infectious disease requirements for Phase 1 clincal trials. Dr. Larouche will discuss the practical dimensions of the problem, and what must be done at the clinic level, over and above regulatory requirements.
Speakers: Dr. Agnes Klein, MD, MPH, Director, Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate, Health Canada
Dr. Richard Larouche, BPharm, MD, Director, Medical Affairs, Early Stage Development, Pharmanet/i3
Protection of Phase 1 Research Volunteers in an Age of Pandemics and Re-emergence of Contagious Diseases Long Thought Conquered Jan 18/13
The goal of this presentation is to provide an understanding of the current regulations and continued challenges, future directions by the regulatory authorities and provide insight into the regulatory pathway for biosimilar and biobetter registration
Speaker: Dr. Steven Engel, MS, PharmD, Senior Principal Scientist, Worldwide Regulatory Affairs, Merck & Co., Inc.

FDA New Guidelines for Biosimilars and Biobetters: An Outlook for 2013

Jan 16/13

LifeSciences This webinar will address the various clinical, regulatory (US & EU) and commercialization strategies that may be implemented in the development of products to treat rare diseases and orphan indications
Speaker: William C. Maier, PhD, Chief Scientific Officer, REGISTRAT-MAPI
Clinical, Regulatory and Commercialization Strategies for Rare Diseases Jan 15/13
LifeSciences In this webinar we will discuss how evidence generated for regulatory purposes can be useful for CER
Speakers: Jeroen Jansen, PhD, Vice President, Health Economics & Outcomes Research, MAPI Consultancy
Carl de Moor, PhD, Vice President Epidemiology, REGISTRAT-MAPI, North America
Comparative Effectiveness Research – The Role of Evidence Synthesis and Non-randomized Real World Studies Dec 11/12
LifeSciences This presentation will explore requisite study designs and detail the procedures routinely employed in support of scientific and regulatory best practices in assessing auditory safety
Speakers: Matthew Abernathy, MS, Associate Scientist, MPI Research
Rachel Tapp, BS, LATG, Study Director, MPI Research
What’d You Say? Understanding Nonclinical Auditory Safety Evaluations Dec 7/12
LifeSciences This webinar will explore the current regulatory and scientific challenges facing industry engaged in developing biosimilars with emphasis on EU and US regulatory framework.
Speakers: Carolyn Finkle, Vice President, Global Regulatory Consulting, Catalent Pharma Solutions
Vincy Abraham, Senior Manager, Bioanalytics Catalent Pharma Solutions
Biosimilars: Creating Workable Solutions to Global Regulatory and Analytical Challenges Nov 30/12
LifeSciences This presentation will provide an overview of cell based potency assays, including current regulatory expectations as well as trends within the industry
Speakers: Weihong Wang, Ph.D., manager of Molecular and Cell Biology Services, Eurofins Lancaster Laboratories
Darren Kamikura, Ph.D., Research Scientist, Eli Lilly and Co
Outsourcing Cell Based Potency Assays: Perspectives from a Sponsor and a Contract Testing Laboratory Nov 15/12
LifeSciences The purpose of this webinar is to discuss recent changes in regulatory requirements and their impact on the clinical supply chain, including the QP release process, considerations when using comparators, and cold chain/temperature sensitive materials
Speaker: Ronnie Constable, Director of Quality, Fisher Clinical Services
The Changing Role of the QP and Regulatory Challenges That Impact the Clinical Supply Chain Nov 14/12
LifeSciences During this webinar, you’ll get practical guidance from CMC experts on a stepwise approach to determining if, what type, and how much extractables/leachables data may be required to address the regulatory concerns
Speakers: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Ken M. Wong, M.Sc., Senior Scientist, Center for Extractables and Leachables, Merck & Co.
Supply Chain Changes in Phase III/Post-Commercialization: Regulatory Considerations for Container/Closure Systems Nov 6/12
LifeSciences This webinar will provide insight into the various regulations which direct pediatric diabetes drug development for registration globally
Speakers: Cynthia Jackson, DO, Leader, Pediatric Center of Excellence, Quintiles
Paul Strumph, MD, Leader, Diabetes Center of Excellence, Quintiles
Robin Huff, PhD, Sr. Director, Global Pediatric Regulatory Strategy Lead, Quintiles
Moderator: Rick Turner, PhD, Sr. Scientific Director, Corporate Communications, Quintiles
DIABETES DRUG DEVELOPMENT: A Perspective on Pediatric Indication Planning Oct 19/12
LifeSciences The speakers will provide a definition of RBM, insight into the regulatory landscape, and a perspective on executing RBM leveraging the three elements of people, process and technology
Speakers: Thomas Grundstrom, Vice President, Integrated Processes and Technologies and Global Head, Quintiles Infosario®
Amanda Sax, Senior Director, Integrated Processes and Technologies, Quintiles
Risk-based Approach to Monitoring: The Future Roles of People, Process & Technology Oct 15/12
LifeSciences During this webinar, you’ll get practical guidance from CMC experts on how to avoid the most common development hiccups and E&L pitfalls related to container/closure selection and regulatory requirements
Speakers: Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories
Allan R. Moorman, Ph.D., President and Chief Operating Officer, Alta Vetta Pharmaceutical Consulting
You Have Received Extractables Information From Your Container/Closure Manufacturer. Now What? Oct 10/12
LifeSciences Our speakers will provide insight into primary cost drivers and explore key activities that can help make the biggest impact to improving profitability, as well as discuss strategies for outsourcing, as well as example process and technology approaches to improve efficiency and governance
Speaker Panel from Quintiles: Geoff Garabedian, VP and Managing Director - Regulatory & Quality and Horizontal Capabilities
Peter Lassoff, Pharm.D., Vice President and Head, Global Regulatory Affairs
Uwe Maennl, MD, Ph.D., MBA, Vice President and Global Head of Lifecycle Safety
Regulatory & Safety Operations: Unlocking Additional Value of Your Marketed Products Sep 28/12
LifeSciences The presentation give an overview of the advantages of conducting clinical trials in emerging markets, an analysis of the importance of start-up timelines in the decision-making process when selecting geographies for a global clinical trial, and a review of the regulatory challenges that can be anticipated when starting up a trial in Russia
Speakers: Leon Dzivinsky, Senior Vice President & General Counsel, ClinStar, LLC / IMP Logistics
Richard Koenig, Vice President of Operations, ClinStar
Study Start-up: A Comparison Across Emerging Markets Sep 13/12
LifeSciences The session will address key regulatory expectations and the role of ethics committees in pediatric development
Speakers: Daniel Brasseur, MD, PhD, Chairman of the EU Paediatric Committee (PDCO)
Petra B. Knupfer, MD, MBA, Managing Director of the Ethics Committee, Medical Association of Baden-Württemberg, Germany
Moderator: Kathy Bohannon, Principal Strategist, Pediatrics, INC Research
Regulatory Authorities and Ethics Committees: Perspectives from Europe for Pediatric Drug Development Sep 11/12
LifeSciences Although the Guidance remains in draft form, it is clear that the key elements of the Final Guidance will likely be retained. Some sponsors and CROs have already begun to adopt a risk-based approach, but the key questions around operationalizing the Guidance and its implications to all drug development stakeholders remain. The discussion will include perceptions from the legal and regulatory perspective, recent initiatives at the highest levels to integrate a risk-based approach to clinical trial monitoring, and practical implementation aspects of risk based monitoring.
Speakers: - Mr. Gary Yingling, BS, MS, JD, Partner, K&L Gates, Washington DC
- Nicholas Alp, PhD, BM BCh, FRCP, DM, Vice President, Scientific Council, ICON plc, and Hon. Consultant Cardiologist, Oxford University Hospitals NHS Trust
- Anick Duchesne, BSc, DSA, Senior Director, CRA Management - North America, ICON plc
A Risk-Based Approach to Monitoring - Implications for Sponsors, CROs, Investigators and IRBs — AN UPDATE Sep 6/12
LifeSciences This webinar will discuss compounding at the clinic’s pharmacy as a means to accelerate development and minimize CMC development resources
Speakers: William Schachtner, associate director, small molecule and inhalation product testing services, cGMP laboratory, PPD
Eugene McNally, Ph.D., executive director, global CM&C, global regulatory affairs, PPD
Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 4: Accelerating to Phase I Clinical Trials for All Dosage Forms
Jun 7/12
LifeSciences The speakers will discuss the benefits of conducting clinical trials in Russia and parts of Eastern Europe compared to other emerging markets, address many of the questions and concerns Sponsors have about logistics, and introduce five keys to successfully managing clinical trial logistics in this region
Speakers: David Passov, CEO, ClinStar
Leon Dzivinsky, Senior Vice President & General Counsel, ClinStar, LLC / IMP Logistics
5 Keys to Successful Clinical Trial Logistics in Russia, Ukraine and Belarus May 17/12

This presentation will address: the importance of E&L for patient and product safety, a well-planned and thorough E&L study design for the entire drug development and manufacturing process, and the types of E&L evaluations that are being performed for dosage forms other than just orally-inhaled and nasal products and which will help prevent delays in regulatory approvals
Speakers: Derek Wood, laboratory manager, cGMP laboratory, PPD
Istvan Kovac, Ph.D., senior research scientist, cGMP laboratory, PPD
Contributor: Xiaochun Yu, Ph.D., principal scientist, cGMP laboratory, PPD

Webinar Series: Innovative Analytical Approaches to Expedite Product Development
Part 2: Timely and Thorough Extractables/Leachables Evaluations to Expedite Regulatory Approval
May 10/12
BusinessStrategy This program will analyze the basis of India’s Regulatory environment, the regulations [both current and future] of clinical trials in India, and the challenges faced in the present scenario
Speakers from Max Neeman International: Renu Razdan, PhD, Chief Operating Officer
Vandana Pandey, Manager Regulatory Affairs
Clinical Research in India – Regulatory Environment May 9/12

The panel, representing both big pharma, and small biotech, and will speak from deep experience about the likely intended and unintended consequences of the new guidance
Speakers: Jack Corman, President, IRB SERVICES
Nestor Nituch, Director Clinical Research, Bristol-Myers Squibb Canada (retired)
Terri Hinkley, RN, BScN, MBA, CCRC, Director, Clinical Operations, Helix BioPharma
Ronald Fehst, President, Ronald Fehst Research Consultants

New FDA Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring - Implications for Sponsors, CROs, Investigators and IRBs May 1/12

This webinar will provide insight into the latest scientific and regulatory thinking around the use of early-phase QT data and concentration QT modeling as a predictor of cardiac risk, ultimately improving decisions about further development and future study design
Speakers: Dhiraj Narula, MD, MRCP UK, DM Card, FACC, FISE, Medical Director, Quintiles Cardiac Safety Services
J. Rick Turner, PhD, Senior Director, Quintiles Integrated & Translational Cardiovascular Safety
Jared Schettler, MS, Associate Director, Quintiles Phase I Biostatistics

EARLY CLINICAL INSIGHTS: The Case for Early Cardiac Safety Data & Modeling Apr 10/12
LifeSciences This webinar will examine the new EU legislation and its impact on the pharmacovigilance practice of regulators and the pharmaceutical industry in years 2012-2016
Speaker: Jan Petracek, MD, MSc, DIC, Partner, CEO, PharmInvent
EU Pharmacovigilance Change Readiness 2012 Apr 4/12
BusinessStrategy This program will analyze the basis of India’s Regulatory environment, the regulations [both current and future] of clinical trials in India, and the challenges faced in the present scenario
Speakers from Max Neeman International: Renu Razdan, PhD, Chief Operating Officer
Vandana Pandey, Manager Regulatory Affairs
Donald Swankie, MBA, Vice President, USA
Asia-Pac Clinical Research – Regulatory Environment Mar 28/12
LifeSciences This first webinar in the series will examine the the advantages and disadvantages of conducting clinical trials in Russia, the clinical studies cycle, regulatory environment, and impact of the new Drug Law in Russia on the clinical trials
Speakers: Igor Stefanov, Director, General Manager, Synergy Research Group
Anna Ravdel, Director of Business Development, Synergy Research Group
Evgeny (Eugene) Rogov, MD, PhD, JD, Deputy Head of Clinical Trials State Control Department (ROSZDRAVNADZOR)
WEBINAR SERIES: Conducting Clinical Trials in Emerging Markets
Part 1 - Russia: Understanding the Regulatory Environment, Challenges & Benefits
Mar 13/12
LifeSciences Our speakers will discuss interventional observational studies, including different types of data that can be collected, different country regulations and approval processes, and setting up and running international real-world observational studies
Speakers: Dr. William Maier, Chief Scientific Offier & VP Epidemiology, Drug Safety and Risk Management, Registrat-Mapi
Dr. Carl de Moor, Vice President Epidemiology, North America, Registrat-Mapi
Sarah Rosen, Global Project Director, Registrat-Mapi
International Real World Post-marketing Studies that Involve Patient Intervention Mar 12/12
LifeSciences The purpose of this presentation is to discuss how DART capabilities have been introduced into an established toxicology laboratory at Southern Research, in compliance with Good Laboratory Practices (GLP)
Speakers: Stephen B. Harris, Ph.D., Fellow, ATS, President, Stephen B. Harris Group
Eve Mylchreest, Ph.D., Program Leader, Developmental and Reproductive Toxicology (DART), Southern Research
Kellye K. Daniels, Ph.D., D.A.B.T., Director, Toxicology and Pathology Services Department, Southern Research
Successful Introduction of GLP-compliant Reproductive Toxicology Programs Feb 28/12
LifeSciences The presentation will include an overview of the FDA’s Animal Rule followed by an example end-user case study
Speakers: Peter Silvera, Ph.D., Program Leader for the Animal Models and Vaccine Program, Southern Research
Michael G. Murray, Ph.D., Director, Department of Infectious Disease, Southern Research
The FDA Animal Rule – Successful Submission of Animal Efficacy Studies Feb 7/12
LifeSciences Topics include a discussion of different models available to commercialisation, IVD and Regulated Laboratory Developed Test (LDT), scalable commercialization pathways, and strategies to reduce CDx development timelines by up to 12 months. Recent case studies with FDA submissions will also be cited to demonstrate a different approach.
Speaker: Alan Wookey, Executive Director, Companion Diagnostics, LabCorp
Companion Diagnostics (CDx): Accelerating the Path to Commercialization Feb 1/12
LifeSciences Learn how to effectively navigate the challenges of conducting clinical trials in Russia and parts of Eastern Europe (EE) and successfully include these emerging markets in rescue trials and as an integral part of your initial study plans
Speaker: David Passov, CEO, ClinStar
Include Russia and Eastern Europe for Successful Clinical Trials Jan 24/12
LifeSciences This webinar will consider recent proposed changes to the regulatory and legislative environment and efforts to better define the roles of the IRB and the investigator in effectively carrying out their responsibilities
Speakers: Greg Koski, PhD, MD, Senior Scientist, James Mongan Institute for Health Policy, Associate Professor of Anesthesia, Harvard Medical School, Associate Editor, Journal for Empirical Research on Human Research Ethics
Jack Corman, B.Sc, B.Ed, President and Founder, Institutional Review Board Services
Human Research Subject Protection: A Time of Reflection, Renewal and Reform? No--It's Time to Redesign! Dec 12/11
LifeSciences Advice on how to create insightful and innovative pediatric strategies that meet the stringent regulatory requirements from the FDA and EMA of pediatric plans for new active ingredients, dosage forms, dosing regimens or routes of administration
Speakers: Dr. med. Klaus Rose, MD, MS, Managing Director, klausrose Consulting
William Sietsema, PhD, Vice President, Regulatory Consulting & Submissions, INC Research
Navigating Pediatric Regulations in the United States and European Union Nov 8/11
LifeSciences The goals of this presentation are to provide clarity on the rationale for this proposed change to the federal regulations; to discuss the potential impact on sponsors, CROs, and academic institutions; to dispel some of the myths regarding the independent review board model and to provide a case study of the collaborative relationship between the Duke University and Copernicus Group IRB in the review and conduct of clinical trials
Speakers: Barry Mangum, Pharm.D., FCP, Director Clinical Pharmacology, Duke Clinical Research Unit
Yvonne Higgins, A.B., CIP, Director Quality Management, Copernicus Group IRB
Reducing the Barriers to the Conduct and Oversight of Clinical Trials: A Case Study Oct 18/11
LifeSciences This webinar will discuss the new US REMS guidance and EU-RMP legislation, and what companies need to do in order to prepare for submissions
Speakers: Dr. William Maier, Vice-President, Epidemiology, Drug Safety and Risk Management, Registrat-Mapi
Dr. Carl de Moor, Vice President Epidemiology, North America, Registrat-Mapi
Dr. Paula Thompson, Senior Epidemiologist, Registrat-Mapi
Risk Management of Drug Safety: Pre-Approval Planning and Research will Ensure Success Sep 23/11
LifeSciences This webinar will review the requirements and practical considerations around preparation and parametric release of drug in a pharmacy clean room to be administered intravenously. In addition, the regulatory requirements around validation and quality control of AMS assays will be reviewed.
Speakers: Staci McDonald, PharmD, Senior Director, Scientific Clinical Operations, Celerion
Stuart Best, PhD, Senior Director of Operations, Xceleron
Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Microtracer Studies Jun 8/11
BusinessStrategy Learn why Madrid is the perfect value-adding location for life science companies to face today’s challenges
Speakers: Vicente Hernández, Pharmaceutical Technical Director and Institutional Relations Manager, Lilly S.A.
Cátia Rabaça, Business Development Unit, Parque Científico de Madrid (Madrid Science Park)
Irene Herrera, Life Sciences Manager, Inward Investment Department, PromoMadrid
Partnering with Madrid’s Life Sciences Industry: Investing in Europe May 11/11
LifeSciences Learn how innovative approaches to Records Management can improve adherence to protocols, instill best practices, ensure regulatory compliance, and most importantly increase business efficiency and decrease TCO
Speakers:  Ron Fitzmartin, PhD, MBA, Managing Partner, Decision Analytics
Dr. Ganesh Swaminathan, Practice Leader Life Sciences, Syntel
Business Aligned Records Management for Life Sciences - Unlock the "Efficiency-Code" in your Content Management Strategy Dec 8/10
LifeSciences This webinar discusses some of the most pertinent changes to regulations regarding compounds coming to approval since the implementation of ICH E14 by the FDA in 2005.
Speakers:  Joy Olbertz, Ph.D., PharmD., Clinical Site Director, Celerion
William Wheeler, M.D., Therapeutic Area Lead Cardiovascular, Celerion
The Need for Speed: Science and Innovation Driving Efficient, Cost Effective QT Assessment Oct 26/10
LifeSciences Supplier Management, Improving Supplier Oversight and Product Quality Outcomes
Speakers: John C. (Jack) Garvey, Principal, Compliance Architects ®
Peter Miller, Senior Partner, Dynamic Compliance Solutions, Inc.
Enforcement Risk Reduction Approaches for FDA-Regulated Manufacturers Apr 28/10
LifeSciences This presentation provides an introduction to the regulatory documents surrounding leachables and extractables testing requirements for pharmaceutical products intended for US submission
Speaker: Alan D. Hendricker, Ph.D., Principal Scientist, Catalent Pharma Solutions
Leachables and Extractables: Regulatory Context Mar 18/10
LifeSciences This webinar will address the principles and practices of stability studies in the drug development process, discuss the framework of the FDA cGMP guidelines as expressed in 21CFR 211 which will help pharmaceutical analysts to understand the process, and provide a comprehensive review of the ICH and WHO stability guidelines and discuss the strategy used in stability protocols design to support global registration
Speakers: Wei Pan, Ph.D. RAC, Senior Manager, Catalent Pharma Solutions
Kathy Waddle, Director, Stability QC Biology, Catalent Pharma Solutions
Stability Studies in Pharmaceutical Development Nov 20/09
LifeSciences Join our webcast as we discuss paperless clinical trials, covering the initiatives, the progress and what we have learned along the way
Speakers: Gail M. Farfel, Ph.D., President, Pharmaceutical & Regulatory Strategy, GM Group Consulting
Alison Shurell, Vice President, Life Sciences Product Marketing, IntraLinks
The Journey Toward Paperless Clinical Trials Nov 5/09
LifeSciences This program is intended for clinical research and regulatory affairs professionals who are responsible for or impact their organizations’ efforts applied to clinical trial patient recruitment and retention and/or study site performance
Speaker: Tony L. Hursey, MPH, Vice President, Cardiology & Endocrinology, MMG
Perspectives on Patient Recruitment: Site and Patient Awareness Items and Participant Insurance Coverage Apr 21/09
LifeSciences A panel discussion of a flexible, cost effective approach for today's R&D and clinical supply leaders that accounts for the complexity of the global distribution of the clinical trial supplies
Speakers: Dr. Michael N. Eakins, Principal Consultant, Eakins & Associates
Martin Page, General Manager, Catalent Pharma Solutions
Andrew Willis, VP of Regulatory Affairs, Catalent Pharma Solutions
Phil Wilson, Director of Global Trade Operations, Supply Chain and Corp. Security, Catalent Pharma Solutions
Meeting the Challenges of Global Clinical Supply Chain Management Jan 27/09
LifeSciences This presentation will address the recent regulatory initiatives in the U.S. and Europe and how safety registries can effectively be used as part of a risk management, riskMAP, or REMS program strategy
Speaker: Richard Gliklich, MD, President, Outcome
From Registries to REMS, Measuring Safety, Minimizing Risk, and Meeting New Regulatory Requirements Nov 6/08
LifeSciences Collaboration, Harmonization and KPI with Blue Mountain Regulatory Asset Manager
Speaker: Bryce Johannes, Director of Marketing, Blue Mountain Quality Resources, Inc.
Improving Productivity in Asset Management for Life Sciences May 8/08
LifeSciences The key challenge areas associated with serializing distribution processes and best practices learned from the front line with early adopters
Speakers: Ann Grackin, Mangaging Director, Supply Chain Risk (RISC) Consulting, Marsh Advisors
John DiPalo, Senior Vice President, Product Development, Acsis
Mike Lipton, Director of Strategy for RIFD/Supply Chain Management, SAP Labs
James Dowden, Director, Distribution Services, Hoffman La-Roche
Best Practices for Serialized Distribution in Support of ePedigree Compliance Jan 31/08
LifeSciences Harmonizing calibration, maintenance and validation with the new Blue Mountain Regulatory Asset Manager enterprise solution
Speakers: James Erickson, President and CEO, Blue Mountain Quality Resources, Inc.
Bill Taliaferro, Director of Global Sales, Blue Mountain Quality Resources, Inc.
Implementing Asset Management Best Practices for Life Sciences Oct 9/07

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