EMWA Symposia
Details of all EMWA symposia are given below. Presentations from the last 3 symposia are available to EMWA members by clicking on the links.
EMWA'S SEVENTH ONE-DAY SYMPOSIUM MAY 2019.
Real-World Evidence: A Central Role for Medical Communicators
The seventh EMWA symposium day provided a comprehensive overview of the fast-moving area of real-world evidence (RWE). With increasing demand for robust RWE from regulatory and reimbursement decision-makers alike, clear and transparent communication is essential to overcome the current level of mistrust in this form of evidence.
EMWA members can view presentations that were made at this event by clicking on the links below.
Introduction to RWE - what is it, and why do we need it?
How RWE is generated - studies, databases, methods and analytics
External challenges for the acceptance of RWE - Patrice Verpillat
External challenges for the acceptance of RWE - Richard White
Big data, digital biomarkers and emerging data sources - Shahid Hanif
Big data, digital biomarkers and emerging data sources - Adrian Jonas
Big data, digital biomarkers and emerging data sources - Jennifer Wong
Best-practices and guidance on the communication of RWE - Annick Moon
Best-practices and guidance on the communication of RWE - Thomas Wagner
A publisher's view on RWE studies and articles - Andrea Bucceri
A publisher's view on RWE studies and articles - Joanne Walker
EMWA'S SIXTH ONE-DAY SYMPOSIUM MAY 2018.
Medical Devices and Technologies - Emerging Opportunities for Medical Writers
The sixth EMWA one-day symposium focused on medical devices and the recent changes in the European legislation, targeting regulatory writers and medical communicators alike. It provided the perspectives of different stakeholders, including medical writers, legislators, notified bodies, medical device companies, patient representatives, and reimbursement professionals.
EMWA members can view presentations that were made at this event by clicking on the links below.
Claudia Frumento - EMWA Symposium 2018
Gillian Pritchard - EMWA Symposium 2018
Ivan Krstic - EMWA Symposium 2018
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
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