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
Keep an eye out for our future events.
Upcoming PV SIG Meet&Share - Monday 11th March, 2:00-3:00 pm CET
Topic: “Concerns with Safety Concerns”
Speaker: Sven Schirp, Boehringer Ingelheim
Dear members, in this Meet&Share is all about safety concerns in PBRERs and RMPs. You will learn how to manage changes in the list of safety concerns of a medicinal product during the life-cycle between the two most relevant PV documents. Sven will share his wide experience and his considerations. All members will have the opportunity to ask questions and share their own experience. This Meet&Share will be moderated by our PV SIG’s supporting volunteer Maria Gullberg. Do not miss this chance, see you there!
Tiziana von Bruchhausen
Please click here to register. Please note, this event is for EMWA members only.
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!