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Strengthening and Optimisation of Regulatory Procedures

Track:
Hot Topic/Stand Alone

Day & Time:
April 18, 8:30AM - 6:30PM (Central Europe Standard Time)

Session Number:
S1100

Type:
Session

Title:
NCA Showcase: Brexit Implications for the EU27 Network and Decentralised Activities

Chair(s):
Christa Wirthumer-Hoche, PhD
Head; Chair, EMA Management Board
Austrian Medicines and Medical Devices Agency (AGES), Austria

Description:
This session gives the floor to the National Competent Authorities (NCA) to discuss their local progress, burning topics, and stakeholder engagement regarding Brexit.

Presentation(s) & Speaker(s):
How is Industry Preparing?
Virginia Acha, PhD, MSc
Executive Director, Global Regulatory Policy
MSD, United Kingdom

HMA Brexit Task Force
Hugo Hurts
Executive Director
Medicines Evaluation Board (MEB), Netherlands

Focus on MRP/DCP
Laura Oliveira Santamaria
Head of RRAA Division, Human Medicines Department
AEMPS, Spain

Strengthening and Optimisation of Regulatory Procedures
Stan A van Belkum, MSc
Acting Director
Medicines Evaluation Board, Netherlands