Regulatory Writing Special Interest Group (RW 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. 

RW SIG

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

RW SIG Objective

The RPD SIG objective is to provide a forum for the discussion and sharing of information, best practices, and ideas with EMWA members.

RW SIG Administration

RW SIG co-chairs:

Jules Kovacevic and Sarah Hopwood

RW SIG Committee Members:

RW SIG Activities

• RW–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.

Get Involved

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