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.
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)
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
EMWA Spring conference 2022: the PV SIG is organising a sub-session of the Regulatory Expert Seminar (Friday 6th May 2022, 9:00 – 12:15):
Accelerated authorisation procedures in the EU: the example of Covid-19 vaccines:
- Introduction on how risks and benefits are defined and assessed for vaccines
- Leveraging the experience of COVID-19 vaccines on accelerated procedures
- Evaluation of efficacy and safety of COVID-19 vaccines from a procedural perspective in the EU: accelerated authorisation procedure, conditional marketing authorisation, rolling review, safety updates
- A medical writing perspective: challenges and specific requirements of RMPs for COVID-19 vaccines
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!