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

PV Requirements in Emerging Markets
26-10-2017

Regulatory expectations around risk management for medicinal products in emerging markets are competing with the stringent standards set by the ICH regions. The diversity of PV-relevant regulations call for a finely tuned balance to ensure that all PV systems employed by a company tie into a global PV matrix.

Our experts will give you a detailed update on the current legal and regulatory background and on your duties with regard to:

  • ADR collection and reporting;
  • PSUR and RMP requirements;
  • PSMF in specific emerging countries.

Moreover, our seminar will help you create a structure to integrate your local PV system into a global system.

26 - 27 October 2017 in Wiesbaden