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

DIAlogue Sessions

Day & Time:
April 17, 1:00PM - 5:30PM (Central Europe Standard Time)

Session Number:


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

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 will come into effect on the 1st of February 2018. During this session we will engage in a dialogue with the different stakeholders (e.g. regulators, industry, academics etc.) on the clinical and non-clinical aspects of the guideline. By reviewing case studies, we will aim for an aligned understanding and implementation of this new important document.