Upcoming events / Executive Training
  • September

    19

    2017

    Marketing Authorisation Outside the ICH Region

  • September

    20

    2017

    PharmaFORUM Webcast International

  • September

    25

    2017

    Masterclass EU QPPV

  • September

    28

    2017

    Regulatory Leaders FORUM

  • September

    28

    2017

    HTA Assessment in Germany, Spain, the UK and the EU

  • October

    09

    2017

    Pharmacovigilance Inspection Readiness

  • October

    17

    2017

    Advanced Pharmacovigilance Writing and Management

  • October

    17

    2017

    CMC Documents: Scientific Writing for Regulatory Submission

  • October

    24

    2017

    Marketing Authorisation in ASIA

  • October

    25

    2017

    Getting Biosimilars on the US Market

  • October

    26

    2017

    PV Requirements in Emerging Markets

  • November

    21

    2017

    Marketing Authorisation for Human Medicines in Latin America

  • November

    22

    2017

    Off-Label Use in Europe

  • November

    27

    2017

    EU Regulatory Affairs Introductory Training Course

  • November

    29

    2017

    Scientific Writing: Abstracts and Posters

  • December

    06

    2017

    The EU Regulatory Affairs Expert

  • December

    07

    2017

    Set up of a Global PV Quality & Compliance System

  • January

    23

    2018

    Toxicology Winter School

Advanced Pharmacovigilance Writing and Management
17-10-2017

This workshop provides insights into RMP and PSUR preparation, assessment and regulatory management.

After completing the seminar, you will:

  • be able to handle your RMP updates correctly;
  • be familiar with the tasks and duties of a QPPV in the lifecycle of PSURs and RMPs;
  • know the tips and tricks for strategic planning and project coordination as a pharmacovigilance writer;
  • be able to handle EU assessment reports; and
  • have a good understanding of the planning, preparation and management of additional risk-minimisation measures.

Insights into the global management of pharmacovigilance documents round off this seminar.

17 October 2017 in Frankfurt