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Effective Implementation of the Revised EMA First-in-Human (FIH) Guidance to Accelerate Your Early Clinical Development


Date: Tuesday, January 16, 2018

Time: 10am EST / 3pm GMT (UK) / 4pm CET (EU-Central)

Duration: 60 minutes

Featured Speakers:

This webinar will cover the key aspects of the revised guidance in relation to early phase regulatory strategy including:

  • Risk mitigation
  • Quality
  • Non-clinical data
  • Nature of the target
  • Starting dose for healthy volunteers and patients
  • Moving from single ascending dose (SAD) to multiple ascending dose (MAD)

In addition, the speakers will discuss the use of integrated protocols (umbrella protocols) to maximise programme efficiency. Attendees will learn how to combine multiple standard trials in one protocol, including SAD, MAD, food effect, age and gender, and efficacy in patients.

Register for this webinar to learn how to design suitably-flexible protocols to avoid unnecessary regulatory delays. Recommendations to save time and reduce costs without compromising safety or quality - including delaying opening an IND until you have meaningful patient data, and accelerating proof of concept (PoC) - will also be shared.

Keywords: First-in-human, EMA, Clinical Trials


Dr. Annelize Koch, MBChB, FFPM, Medical Director, Simbec Research

Annelize has over 15 years of experience in the drug development process, including interpretation of preclinical pharmacology/toxicology, Phase I (including first-in-human) pharmacology/PK studies and Phase IIa trials. In addition to her medical degree, Annelize also holds a Certificate of Completion of Training (CCT) in Pharmaceutical Medicine (Royal College of Physicians) and is a Fellow of the Faculty of Pharmaceutical Medicine. Annelize has extensive experience in the running of Phase I studies as well as scientific knowledge of the design and management of clinical studies. Annelize has held medical positions at Paraxel and GSK.

Dr. Simon Hutchings, MPharmacol PhD CHP, Director Scientific Affairs, Simbec Research

Simon has over 10 years of experience in the drug development process, including pre-clinical pharmacology/toxicology, Phase I (including first-in-human) pharmacology/PK studies and investigator-led Phase II/Phase III trials. In addition to undergraduate and postgraduate qualifications in pharmacology, Simon also holds a Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine (Royal College of Physicians).

Simon has extensive practical experience and scientific knowledge of the design, management and reporting of clinical development projects. He was a contributor to the revised 2017 EMA First-in-Humanguidance and is Chair of the EUCROF Early Phase Research Working Group.


This webinar is for biotechnology companies who have compounds in the preclinical stage preparing to enter clinical operations.

Relevant job functions include:

  • CEO
  • CMO
  • CSO
  • VPs/Directors of Clinical Operations
  • VPs/Director of Clinical Pharmacology
  • VPs/Directors of Translational Medicine


Orion Clinical is the full-service clinical development division of Simbec-Orion Group.

Founded 20 years ago as a full service CRO we have expanded, through consistent delivery of studies in complex areas. Our operations are based in the United Kingdom, France, USA, Germany and Italy. We have operational staff across mainland Europe (Western, Eastern & Central) and throughout North America.

With over 20 years of experience in the delivery and conduct of oncology clinical trials, including rare & orphan and paediatric studies, we use our skills elegantly to design, execute and deliver our clients' clinical development needs.

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