Medical Writing Public Disclosure The Regulatory Public Disclosure Special Interest Group

Volume 27, Issue 2 - Public Disclosure

The Regulatory Public Disclosure Special Interest Group


Who are we and what do we do ?

The Regulatory Public Disclosure Special Interest Group (RPD SIG) was first conceived in December 2015 and is a group of EMWA members supporting other EMWA members. The RPD SIG objective is: “to provide a forum
for the discussion and sharing of information, best practices and ideas with EMWA members,” as mentioned at the RPD SIG’s launch at the Munich conference in May 2016. The concept of creating SIGs was initiated by EMWA in 2015 with the creation of the first SIG covering pharmacovigilance. The RPD SIG took up the
baton shortly afterwards. Christopher Marshallsay and I jointly chair the RPD SIG and are supported by other eager volunteers – either as part of the committee or as part of the advisory panel, our “global due diligence network” – who support technical and regulatory questions for the SIG.


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President’s Message
The Regulatory Public Disclosure Special Interest Group
Clinical trial disclosure and transparency
Navigating the EMA clinical data website
Anonymisation reports from 2016 to 2017: A preliminary analysis
Preparing anonymisation reports in general and for an orphan drug in particular
Policies 0070 and 0043: Juggling different requirements
Clinical data publication by the EMA: The challenges facing the pharmaceutical industry
Clinical trial results disclosure on and EudraCT
Writing lay summaries: What medical writers need to know
Lay titles for clinical trials: A balancing act
Why clinical study reports really matter
CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure
Preparing clinical study reports for external sharing
Harmonising format and style requirements for scientific and medical publications
News from the EMA
Winners of the Geoff Hall Scholarship Essay Competition
Creative medical writing: An oxymoron?
Creative medical writing - An oxymoron?
An interview with Chris Winchester
Journal Watch
In the Bookstores
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Out on Our Own
Upcoming issues ofMedical Writing

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