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

Next events:

  • Joint CwP SIG and PV SIG Expert Seminar on “Safety communication to patients” (ESS #4) – Spring Conference (Prague) on Friday May 12 13:30-17:00
  • Seminar on “Introduction to benefit-risk assessment for medical writers” – Spring Conference (Prague) on Thursday May 11 17:00-18:30

Heads-up of further upcoming events:

  • Meet&Share on RMPs vs. REMS Monday 5th June at 14:00 CEST (virtual)

Risk Management Plan - EU and FDA Perspective

In this Meet&Share, we will address differences and similarities between RMPs (EU requirement) and REMSs (US requirement). Join us to share your questions and experience! Please register for this session by sending an email to EMWA: info@emwa.org. We will confirm your registration and send a calendar invite with the zoom details. 

  • Meet&Share on PSURs vs. DSURs in September (virtual)
  • Webinar on Adverse Events Reporting in September (virtual)

Short abstracts of these events, as well as the exact date and time, will be shared soon - stay tuned!

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!