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.

PDF IconIntroduction to RWE - what is it, and why do we need it?

PDF Icon How RWE is generated - studies, databases, methods and analytics

PDF Icon Registries as a source of RWE

PDF Icon External challenges for the acceptance of RWE - Patrice Verpillat

PDF Icon External challenges for the acceptance of RWE - Richard White

PDF Icon Big data, digital biomarkers and emerging data sources - Shahid Hanif

PDF Icon Big data, digital biomarkers and emerging data sources - Adrian Jonas

PDF Icon Big data, digital biomarkers and emerging data sources - Jennifer Wong

PDF Icon Best-practices and guidance on the communication of RWE - Annick Moon

PDF Icon Best-practices and guidance on the communication of RWE - Thomas Wagner

PDF Icon A publisher's view on RWE studies and articles - Andrea Bucceri

PDF Icon 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.

PDF IconClaudia Frumento - EMWA Symposium 2018

PDF Icon Gillian Pritchard - EMWA Symposium 2018

PDF Icon Ivan Krstic - EMWA Symposium 2018

PDF Icon Oleg Borisenko - EMWA Symposium 2018

PDF IconPaul Piscoi - 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.

PDF Icon Disclosure of Clinical Regulatory Documentation The (IQWiG) User Perspective

PDF Icon Disclosure of Clinical Regulatory Documentation - The Medical Writer Perspective

PDF Icon Update on EU Transparency in clinical trials

PDF Icon Clinical Trial Disclosure - Status Update - Regulation 536/2014

PDF Icon CORE Reference - One Year On




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.

PDF Icon Overview of risk-benefit evaluation – Art Gertel

PDF Icon The European Medicines Agency perspective – Juan Garcia

PDF Icon Medical writer’s perspective – Sven Schirp

PDF Icon Industry perspective – Peter Verdru

PDF Icon Patient perspective – Erik Briers

PDF Icon Patient perspective – David Gilbert