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Workshop: Revision of the EU Clinical Trial Risk Mitigation Guideline

Tutorial name:
Workshop: Revision of the EU Clinical Trial Risk Mitigation Guideline

Day & Time:
April 16, 2:00PM - 5:30PM (Central Europe Standard Time)

Registration Fees
- Standard Rate€450.00

Jan Willem van der Laan, PhD
Senior Assessor Pharmacology and Toxicology
Medicines Evaluation Board, Netherlands

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

In July 2017, the EMA released a revised 'Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products’. This workshop aims to explain/teach the guidance, with involvement of assessors from regulatory agencies. The course will begin with presentations on the nonclinical issues and discussions on Dose Selection. The second part will focus on design elements and key aspects of the FIH and Early Clinical Trials and clinical monitoring. The speakers have been members of the drafting group involved in the finalisation of the guideline.

Learning Objective(s):
At the conclusion of this short course, attendees will be able to: • Recognise the revisions of the Guideline in relation to the previous version from 2007. • Identify the regulatory issues for designing new First-in-Human and early clinical trial protocols

Target Audience:
This course is designed for non-clinical and clinical experts in pharmaceutical industry involved in drug discovery and early clinical development; CROs, consultants, project managers, employees of FIH clinical trial units, regulatory affairs professionals, and regulatory assessors involved in clinical trial approval.