Regulatory Public Disclosure Special Interest Group (RPD SIG)

 

RPD SIG Resources

  • Glossary – look here for definitions of key abbreviations and terms
  • Key references – look here for key references (laws, guidance documents, publications) listed together with suitable links
  • Background reading & viewing – look here for some background reading and videos
  • If you have a new question, then email your question to RPDSIG@emwa.org
  • Question & Answer Log – if you have a question, look here first. Perhaps the same question was already raised and answered

What is ‘Regulatory Public Disclosure’?

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

  • Publication professionals understand it to mean the publication of research findings whether the outcomes are negative or positive; the disclosure of funding; disclosure of involvement of medical writers in publication development; conflict of interest etc.
  • Regulatory professionals understand it to mean the:
    • Registration, status reporting, and results posting of clinical studies in publically accessible internet registries.
    • Upon-request or proactive sharing of clinical regulatory documents (e.g., synopses, clinical study reports, clinical overviews, clinical summaries) and/or individual patient data.
    • Publishing of clinical trial results in journals.

RPD SIG Launch Video - Munich 12th May

 

RPD 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.

Why is Public Disclosure of ‘Special Interest’ to Regulatory Medical Writers?

The concept of ‘regulatory public disclosure’ is of special interest because of:

  • It's impact on the content and structure of standard regulatory documents.
  • The expectation that the range of regulatory documents impacted will burgeon in the coming years.
  • Public disclosure will create the need for new regulatory documents, which the medical writer will support.

RPD SIG Administration

The RPD SIG Chairs are Dr Christopher Marshallsay and Tracy Farrow.

The RPD SIG website is maintained by Kingston Smith Association Management.

The RPD SIG Advisory panel includes Art Gertel, Sam Hamilton, Kathy Thomas-Urban.

 

Tracy Farrow GIBiol
Senior Director of Medical Writing, PPD, Cambridge, UK

Tracy is currently Senior Director, Medical Writing for PPD where she is responsible for EMEA and APAC medical writing and PPD’s global data transparency initiative. Tracy has more than 25 years of biomedical science experience. Before PPD she worked for ClinTec International as Manager, Medical Writing Services; and Pfizer as Medical Writing Therapeutic Area Lead, and Quality Manager for Data Management where she was responsible for data privacy training, audit management, SOP and best practice development. She lectured in Intermediate Laboratory Data Management for the Association for Clinical Data Management for a number of years as part of their professional development program. She attained her (Hons) G.I.Biol in Biochemistry in 1993 after gaining two Higher National Certificates in Haematology and Chemistry. From May 2014, Tracy has been a member of the EMWA-AMWA Budapest Working Group Oversight Review Team, with special responsibility for the area of transparency and public disclosure in relation to clinical-regulatory documents.

Dr Christopher Marshallsay
Director, Head Medical Writing and Public Disclosure, Grünenthal GmbH, Aachen, Germany

Chris is currently Head Medical Writing and Public Disclosure at Grünenthal in Aachen where he is responsible for medical writing and public disclosure activities worldwide. The latter includes responsibility for trial registration, status reporting, and results reporting in registries, clinical data sharing, and document redaction for commercially confidential data and protected personal data. He has a PhD in biochemistry and 19 years’ experience in various roles in clinical development (i.e., in pharmacokinetics, medical writing, public disclosure, as department head, and as function head). Previous employers were the European Molecular Biology Laboratory (Heidelberg), Ciba-Geigy (Basel), Institute for Molecular Biology & Tumor Research (Marburg), sanofi and its predecessor companies (Frankfurt and Paris). He is an expert in continuous improvement and an experienced lecturer/workshop leader.