Regulatory Writing Special Interest Group (RW SIG)

 

Regulatory Writing Special Interest Group (REG SIG)

The Regulatory Writing Special Interest Group (REG SIG) was created in 2022, expanding the scope of a previous SIG, the Regulatory Public Disclosure SIG. While the REG SIG will still be involved in transparency and disclosure matters, there will be other areas of regulatory writing covered by the SIG.

What is ‘Regulatory Writing’?

‘Regulatory writing’ has different meanings for different groups of medical writing professionals:

  • Regulatory writers understand it to mean documents related to a clinical trial. The extent of these documents can be many and varied, ranging from protocols, informed consent forms and clinical trial reports (CTRs), to investigator's brochures, investigational medicinal product dossiers and many more documents.
  • Safety writers will also consider development safety update reports, periodic benefit-risk evaluation reports, etc.
  • More recently, the scope has expanded to meet newer regulatory requirements, including protocol lay summaries and CTR lay summaries.

REG SIG

The REG SIG regularly presents new information on regulatory writing to members at EMWA conferences.

REG SIG Objective

The objective of the REG SIG is to provide a forum for EMWA members who are working in or have an interest in regulatory writing to discuss experiences and best practices, share information, ask questions, and facilitate networking.

REG SIG Administration

REG SIG co-chairs:

Jules Kovacevic and Sarah Hopwood

Sub-group Leads:

Transparency and Disclosure - Zuoyen Lee

Clinical Regulatory Writing - Sarah Hopwood

Nonclinical Regulatory Writing - Sally Hill

Orphan drugs and rare diseases - Carima Andrady

Paediatric Regulatory Writing - Sarah Milner

Advanced Medicinal Products and Techniques – TBA


REG SIG Activities

REG SIG Activities  

We currently meet once a month on Thursdays at 13:00. We aim to update information on these meeting here, but for the most up-to-date information we encourage you to join our LinkedIn group: https://www.linkedin.com/groups/9545713/

All EMWA members are welcome to join the LinkedIn group where you can go to read REG SIG updates and ask questions.

REG SIG Meeting 5th December 2024 13:00 CET

Please click here to register.

Other REG SIG activities:

  • REG–related news circulated in the EMWA Newsblast serves as a repository for information resources related to regulatory writing, updates to relevant guidelines and related news items.
  • The EMWA Professional Development Programme (EPDP) offers a plethora of workshops in the area of Regulatory Writing which run at EMWA conferences; please refer to the EPDP brochure for full details of all the EMWA workshops.

Presentations, Seminars, and Meet and Shares

Get Involved

Please consider becoming involved and supporting the RW SIG. Contact us by emailing info@emwa.org (marking your email to the REG SIG)