返回 Agenda
Session 5: Hot Topics - Bitesize Updates
Session Chair(s)
Elspeth McIntosh, MBA, RN
Director
Castle Pharmacovigilance Ltd, United Kingdom
The Hot Topics session provides insights in the very latest on discussions in specific Safety areas of interest. Experts will address the latest on topics that are being discussed by the Industry Trade Association (EFPIA - should we be more global?) ?and Regulatory Authorities and will therefore give the audience an insight in the key topics of the moment. The expert speakers that lead these discussions will share information on these key topics, the issues at hand, the progress that is being made and what the audience can expect on these topics for the future. The topics will be of interest to a broad audience and will be of specific value to participants that are not able to attend Industry Association meetings or public meetings with EMA due to limited attendance possibilities.
These are some of the topics that we will cover:
- Transitioning in Transparency
- Risk Management Plans
- EMA Publication of full Periodic PSURs
This session offers a great opportunity to hear about these topics from experts in the field. The audience can expect different exciting presentations that will please the crowd.
Speaker(s)
Windsor Framework – Catch Up
Helen Fiddes
United Kingdom
Head of Country Pharmacovigilance, UK and Ireland
ICH E2D Updates
Michelle Grimes, MSc
MSD, United Kingdom
Head, International Pharmacovigilance. GCS&PV
PVEG taskforce - 'Non-Fixed-Dose Combination'
Magnus Ysander, MD
AstraZeneca, Sweden
EU & UK QPPV & Head Pharmacovigilance Excellence
Electronic Products Information Pilot and the New Pharma Legislation
Koen Nauwelaerts, PharmD, PhD, MBA
Bayer AG, Belgium
Regulatory Policy and Innovation Lead