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Mercure Amsterdam City Hotel

2023 年 11 月 08 日 8:30 上午 - 2023 年 11 月 09 日 5:15 下午

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

This Forum provides valuable insights into the most pressing issues QPPVs are facing today. This event has limited capacity, register early!

Session 5: Hot Topics - Bitesize Updates

Session Chair(s)

Elspeth  McIntosh, MBA, RN

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

  • Signal Detection (Monitoring EVDAS Pilot)
  • Environmental Risk Assessment (Pharma Legislation)
  • 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)

    Helen  Fiddes

    Windsor Framework – Catch Up

    Helen Fiddes

    United Kingdom

    Head of Country Pharmacovigilance, UK and Ireland

    Michelle  Grimes, MSc

    ICH E2D Updates

    Michelle Grimes, MSc

    MSD, United Kingdom

    Head, International Pharmacovigilance. GCS&PV

    Magnus  Ysander, MD

    PVEG taskforce - 'Non-Fixed-Dose Combination'

    Magnus Ysander, MD

    AstraZeneca, Sweden

    EU & UK QPPV & Head Pharmacovigilance Excellence

    Koen  Nauwelaerts, PharmD, PhD, MBA

    Electronic Products Information Pilot and the New Pharma Legislation

    Koen Nauwelaerts, PharmD, PhD, MBA

    Bayer AG, Belgium

    Regulatory Policy and Innovation Lead

    获得信息并保持参与

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