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

Set up of a Global PV Quality & Compliance System
07-12-2017

An effective pharmacovigilance quality and compliance system across all your affiliates and partners worldwide is necessary to comply with the individual regulatory requirements in the countries.

Our experts will provide practical hints on how to design, set up and manage such a global PV quality system. The seminar will discuss:

  • the set up of a global system and tools to monitor its effectiveness;
  • controlled documents and what information they should contain;
  • PSMF as a global document;
  • the role of the EU QPPV in a global PV system;
  • how to prepare for audits and inspections; and
  • how to identify and handle noncompliance.