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DIAlogue: The New EMA First-in-Human (FIH) Guideline

DIAlogue Sessions

Day & Time:
April 17, 1:00PM - 3:30PM (Central Europe Standard Time)

Session Number:

Room Number:
Shanghai 1-2


DIAlogue: The New EMA First-in-Human (FIH) Guideline

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.

Presentation(s) & Speaker(s):
Case Study 1
Joseph Brady, PhD
Senior Director
Pfizer, United States

Case Study 2
Andreas Hartmann, PhD
Executive Director
Novartis Pharma, Switzerland

Panel Discussion
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 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
Professor of Pharmacology; NDA Advisory Board Member
University of Lisbon, Portugal

Panel Discussion
Elke Stahl, PhD
CTFG Co-Chair; Clinical Trial Unit
Federal Institute For Drugs and Medical Devices (BfArM), Germany

Panel Discussion
Ulla Wandel Liminga
Scientific Director
Medical Products Agency, Sweden

Panel Discussion
Kirsty Wydenbach
Deputy Unit Manager, Clinical Trials Unit
MHRA, United Kingdom