EMWA Symposia

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EMWA's Fifth One-Day Symposium May 2017.

Transparency and Disclosure of Clinical Regulatory Documentation

The fifth EMWA one-day symposium focused on the rapidly changing field of regulatory public disclosure requirements and how these changes impact the consumers, the writers, and how information is disclosed. Through the onset of regulatory public disclosure, the importance of “smart writing” – and thus of the medical writer role - has become paramount. Regulatory public disclosure imposes new demands on information presentation in documents, terminologies, document structure, and consistency. There are also overlaps with disclosure aspects in pharmacovigilance.

EMWA members can view presentations that were made at this event by clicking on the links below.

Disclosure of Clinical Regulatory Documentation The (IQWiG) User Perspective

Disclosure of Clinical Regulatory Documentation - The Medical Writer Perspective

Update on EU Transparency in clinical trials

Clinical Trial Disclosure - Status Update - Regulation 536/2014

CORE Reference - One Year On

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EMWA's Third One-Day Symposium May 2015.

RISK MANAGEMENT AND RISK-BENEFIT EVALUATION-A 360 DEGREE PERSPECTIVE

This successful Symposium was moderated by Tiziana von Bruchhausen and Rohit Pushparajan, who welcomed representatives of European Medicines Agency, patient advocate groups, medical writers and different pharmaceutical companies.

EMWA members can view presentations that were made at this event by clicking on the links below.

Overview of risk-benefit evaluation – Art Gertel

The European Medicines Agency perspective – Juan Garcia

Medical writer’s perspective – Sven Schirp

Industry perspective – Peter Verdru

Patient perspective – Erik Briers

Patient perspective – David Gilbert