We are updating our Privacy Policy and Terms and Conditions to help you clearly understand how your personal information is collected, stored and managed. Learn More
Menu Back to Event-Details

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)

Room Number:
Wettstein (Swissotel)

Registration Fees
- Standard Rate€450.00


Instructor(s):
Jan Willem van der Laan, PhD
Senior Assessor Pharmacology and Toxicology
Medicines Evaluation Board, Netherlands

Sharon Evans Schuler,
DIA Europe Content Manager
DIA , Switzerland

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

Gunta Sveke,
Project Manager, Training Courses
DIA, Switzerland

Ulla Wandel Liminga,
Scientific Director
Medical Products Agency, Sweden

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

Sharon Evans Schuler,
DIA Europe Content Manager
DIA , Switzerland

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

Gunta Sveke,
Project Manager, Training Courses
DIA, Switzerland

Ulla Wandel Liminga,
Scientific Director
Medical Products Agency, Sweden

Description:

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 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 element 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, employees of FIH clinical trial units, and regulatory assessors involved in clinical trial approval.