Pharmacovigilance Special Interest Group
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.
• Monthly updates of interest to pharmacovilance writers in the EMWA news blast in the sections "News of interest", "Regulatory updates", and "PV SIG update"
• Planning of yearly updates on relevant pharmacovigilance topics at the future Spring conferences
• We are exploring further areas of interest that could be covered via the journal, workshops, or conference sessions
20 April 2018 at 14:00 to 15:00 CET
Pharmacovigilance Special Interest Group (PV SIG) – what have we been doing for EMWA members and why you should join us!
Tiziana von Bruchhausen & Lisa Chamberlain James
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 and acts as a resource for medical writers interested in the area of PV by posting guidance and updates to guidance as appropriate.
The group has had a very busy year and is planning lots of exciting activities – including some for the upcoming conference. This webinar will present all the latest updates and explain why and how you should get involved!
Registration opens on 6 April 2018.
Upcoming activities at the EMWA 2018 Spring Conference
• The Expert Seminar Session 1 on May 2, 2018 (08:45-11:45) is dedicated to the most recent RMP guidance revision (GVP module V Rev. 2) and the upcoming PSUR guidance revision (GVP module VII). Members of the PRAC, EFPIA, and industry will guide you through the main aspects of the guidance revisions. Do not miss the opportunity to ask your questions to the experts!
• There will be a lunch roundtable discussion on pharmacovigilance on May 2, 2018 (12:45-13:15). This event will offer EMWA members working in pharmacovigilance the opportunity to network and share their experience on selected topics. Join us!
• Workshops related to pharmacovigilance offered at the Spring Conference are as follows:
o DDA15a: Development Update Safety Reports
o DDF32a: Introduction to Pharmacovigilance Writing
o MSF6: Why do drugs and medicines have adverse effects
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 email@example.com and indicate "For PV SIG" in the subject line. We look forward to hearing from you!