The PV SIG aims to address the following training needs and issues:

 

  • Understand the concepts of risk management (e.g. safety concerns and how to mitigate them) and the regulatory requirements in the life cycle of a medicinal product
  • Learn how to apply regulatory guidelines to the preparation of safety documents such as DSUR, PSUR, and RMP
  • Update EMWA members about relevant regulatory news and guidelines of relevance for pharmacovigilance writers
  • Promote the role of professional medical writers in pharmacovigilance

 

PV workshops

(Please check the EMWA website / conference website for the workshop abstracts and the most recent updates)

PV workshops:

  • DDF32 – Introduction to Pharmacovigilance Writing
  • DDF30 – Writing Risk Management Plans
  • DDA20 – Risk Management Plans: Challenges and insights
  • DDA14b – Periodic Benefit-Risk Evaluation Reports
  • DDA32A– Development Safety Update Reports
  • DDA26 - Post-submission PV writing: interactions with authorities and impact on RMPs and PSURs

Workshop related to drug safety:

  • MSF6 – Why do Drugs and Medicines have Adverse Effects?
  • DDF22 – Drug safety for Medical Writers Part 1: Adverse Events and Concomitant Medications
  • DDF23 – Drug safety for Medical Writers Part 2: Laboratory Data
  • PTF15 – Interpreting and Reporting Measures of Risk

 

PV webinars

(Please check the webinars archive for recent updates at the following link: Webinars (emwa.org) )

 

  • Managing safety concerns in DSURs, PBRERs and RMPs – 2020- Sven Schirp
  • Pharmacovigilance writing: monitoring and enhancing patients’ safety throughout the life-cycle medicinal products– 2019 - Tiziana von Bruchhausen
  • Pharmacovigilance Special Interest Group (PV SIG)-what we have been doing for EMWA members and why you should join us– 2018 - Tiziana von Bruchhausen, Lisa Chamberlain James