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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
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)
Case Study 1
Joseph Brady, PhD
Pfizer, United States
Senior Director
Case Study 2
Andreas Hartmann, PhD
Novartis Pharma, Switzerland
Executive Director
Panel Discussion
Charles Benson, MD, PhD
Eli Lilly and Company, United States
Senior Director Clinical Phamacology
Panel Discussion
Roy Forster
Citoxlab, France
Group Scientific Director
Panel Discussion
Walter J J Janssens
Federal Agency For Medicines and Health Products, Belgium
Senior Assessor Preclinical Department Research & Development
Panel Discussion
Peter Pertel, MD, MPH, FACP
Novartis Institutes for BioMedical Research, United States
Global Head of Translational Medicine for Respiratory and Infectious Diseases
Panel Discussion
Sarah Robertson, PharmD
Vertex Pharmaceuticals, United States
Senior Director, Clinical Pharmacology
Panel Discussion
Beatriz Silva Lima, PharmD, PhD
University of Lisbon, Portugal
Director of FFUL, Faculty of Pharmacy
Panel Discussion
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department
Panel Discussion
Ulla Wändel Liminga, DrMed, MS, RPh
Medical Products Agency (MPA), Sweden
Scientific Director Pharmacology/Toxicology
Panel Discussion
Kirsty Wydenbach, DrMed, MSc
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Medical Assessor
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