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) )

  • Pharmacovigilance Webinar: Reporting of Adverse Events – John Praween - September 21st 2023

  • Assessing and Reporting Environmental Risk for Human Medicinal Products throughout Development –  2022 – Diana Radovan and Liron Sarid-Krebs (joint PV SIG / SUS SIG Webinar)

  • An Overview of EU Pharmacovigilance – 2021 – Joan D’souza
  • 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

Meet&Share meetings

  • Meet & Share “PSURs and DSURs & First experiences with the EU CTR requirements for DSURs” - 09 October 2023
  • Meet & Share - “PSURs and DSURs - are they the same?” - 11 September 2023
  • Meet&Share on RMPs vs. REMS -  Monday 5th June 2023
  • Developmental Risk Management Plans (dRMPs)”– 26 September 2022
  • “Demystifying pharmacovigilance writing for new and aspiring medical writers” – 09 June 2022 (joint GIMW and PV SIG Meet&Share)
  • “Post Brexit – Implications for PV” – 28 March 2022
  • “DSUR requirements other than ICH E2F – Be aware! (Impact of EU-CTR and other local requirements on DSURs)” – 13 December 2021