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 Meet & Share 26th November 2024 13:00 CET

There will be a REG SIG Meet and Share on 26th November 13:00 CET with Dr Susan King on “Templates for nonclinical studies”. Please click here to register. 

All EMWA members are invited to join the Regulatory Writing SIG’s upcoming Meet & Share on plan and report templates for non-GLP nonclinical studies. You will meet Dr Susan King, nonclinical regulatory and scientific writer at Johnson & Johnson, who will share her experiences developing templates for nonclinical non-GLP study plans and study reports, used primarily for in vivo pharmacology studies. 

These nonclinical templates – which Dr King will also make available to attendees – have evolved over time based on feedback from various regulatory agencies. In the absence of clear guidance for the content and structure of nonclinical non-GLP study documentation, this is a useful resource to share with other regulatory writers.

During the session, attendees will be asked for input and feedback, and we’ll discuss how we approach the different sections of these documents. We hope you’ll also share your own experiences with the regulators, whether that is as a freelance writer or working as a regulatory writer at a sponsor or CRO.

About our guest:

Dr Susan King has >10 years’ experience in regulatory writing, 8 of which were as a nonclinical regulatory writer in vaccine development. She has been involved in the preparation of scientific and regulatory documents covering the full clinical development pathway, from discovery activities to first-in-human to marketing authorization applications, responses to questions from regulatory agencies, and annual safety reporting. Her work has also involved improving on data traceability and documentation practices and accuracy in study reporting, with a focus on lean reporting. She also has experience managing a small writing team, allocating responsibilities, providing on-the-job training, and enabling growth and development of team members.

There will also be a Reg SIG meeting on 5th December. Registration details to follow.

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)