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DIAlogue: The New EMA First-in-Human (FIH) Guideline
Session Chair(s)
Salah-Dine Chibout
Global Head Discovery & Investigative Safety/Preclinical Safety Therapeutic Area, Novartis Pharma AG, Switzerland
Jan Willem van der Laan, PHD
Senior Assessor Pharmacology and Toxicology , Retired From Medicines Evaluation Board, Netherlands
The EMA has released the revised “Guideline on Strategies” to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products” on the 25th July 2017. This new guidance has come into effect on the 1st of February 2018. During this supersession (150 minutes duration) we will engage in a dialogue with a panel of different stakeholders (e.g. regulators, industry, CROs, academics, etc.) on the most important aspect of the guideline (nonclinical strategy, FIH-dose-selection, sentinel dosing, stopping dose criteria, protocol, etc.). Our aim is to align understanding and implementation of this new important document. Two real-life case studies from industry, differencing in the level of uncertainty, will be presented. Each case study will be followed by a panel discussion featuring non-clinical and clinical industry experts, and various representatives from European regulatory agencies.
Speaker(s)
Joseph Brady, PHD
Senior Director, Pfizer, United States
Case Study 1
Andreas Hartmann, PHD
Executive Director, Novartis Pharma, Switzerland
Case Study 2
Charles Benson, MD, PHD
Senior Director Clinical Phamacology, Eli Lilly and Company, United States
Panel Discussion
Roy Forster
Group Scientific Director, Citoxlab, France
Panel Discussion
Walter J J Janssens
Senior Assessor Preclinical Department Research & Development, Federal Agency For Medicines and Health Products, Belgium
Panel Discussion
Peter Pertel, MD, MPH, FACP
Global Head of Translational Medicine for Respiratory and Infectious Diseases, Novartis Institutes for BioMedical Research, United States
Panel Discussion
Sarah Robertson, PHARMD
Senior Director, Clinical Pharmacology, Vertex Pharmaceuticals, United States
Panel Discussion
Beatriz Silva Lima, PHARMD, PHD
Director of FFUL, Faculty of Pharmacy, University of Lisbon, Portugal
Panel Discussion
Elke Stahl, PHD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
Panel Discussion
Ulla Wändel Liminga, DrMed, MS, RPH
Scientific Director Pharmacology/Toxicology, Medical Products Agency (MPA), Sweden
Panel Discussion
Kirsty Wydenbach, DrMed, MSC
Expert Medical Assessor, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Panel Discussion
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