Pharmacovigilance Special Interest Group
(PV SIG)

PV SIG objectives

The PV SIG aims to bring together EMWA members to discuss and share information and best practice in the area of PV and PV writing via the journal, website, and events at conferences. The group aims to increase dialogue within and between the medical writing community and the Regulatory Authorities (RAs) and acts as a resource for medical writers interested in the area of PV by posting guidance and updates to guidance as appropriate. They liaise with the EMWA Professional Development Committee to advise on additional training for EMWA members in the field of PV writing and PV. 

PV SIG info material 

PV SIG launch video (Lisa Chamberlain James; November 2015)

PV SIG webinar (Tiziana von Bruchhausen & Lisa Chamberlain James; 20 Apr 2018)

Regular activities

The activities of the EMWA's PV SIG range from developing conference workshops, Expert Seminars (ESS) sessions, and webinars, to contributing to journal articles and monthly newsblast sections. The PV SIG aims to update EMWA members and to address the following training needs and issues:

 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

 Establish a dialogue with health authorities and other stakeholders

Promote the role of professional medical writers in pharmacovigilance

Facilitate dialogue between regulators and EMWA members, particularly in the area of pharmacovigilance, by having authority speakers at EMWA conferences

Discussion platforms (Meet&Share) targeting EMWA members working or being interested in PV will be held regularly and advertised in the monthly newsblast.

The PV SIG launched a section dedicated to pharmacovigilance in the Medical Writing journal

Future events

On Thursday, 9th June at 14:00 CET, we will have our joint GIMW and PV SIG Meet&Share entitled:
Demystifying pharmacovigilance writing for new and aspiring medical writers

  • Introduction to pharmacovigilance (PV) writing
  • How to get a PV writing role as a fresh graduate?
  • Experience sharing from aspiring, new, and experienced PV writers
  • Interactive session - a chance for aspiring or new writers to ask questions

Meeting details:


9th June 2pm CET

Email: info@emwa.org to receive your registration invite

Thank you,

Evgenia Alechin and Tiziana von Bruchhausen

Chairs
Getting into Medical Writing (GIMW)
Pharmacovigilance Special Interest Group (PV SIG)

EMWA Spring conference 2022: the PV SIG has organised a sub-session of the Regulatory Expert Seminar (Friday 6th May 2022, 9:00 – 12:15). See the topics below and join us either in Berlin or virtually!

Accelerated authorisation procedures in the EU: the example of Covid-19 vaccines:

- Introduction on how risks and benefits are defined and assessed for vaccines
- Project Lightspeed: leveraging the experience of a COVID-19 vaccine development to shape the future of expedited programs
- Regulatory journey for COVID-19 vaccines at EMA
- Regulatory Requirements for a COVID-19 Vaccine Risk Management Plan: A Medical Writing Perspective

How to contribute to the PV SIG

You are warmly invited to provide updates for the news blast or suggestions for workshops or expert seminars, to write an article or to develop a workshop on pharmacovigilance topics. Please send us your suggestions in an e-mail to info@emwa.org and indicate "For PV SIG" in the subject line. We look forward to hearing from you!