Abstract
April, 6, 2017 – Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of its commitment to continuous process improvement. Two new documents aim at improving the safety information and benefit-risk assessment of medicines in the context of the periodic safety update single assessment (PSUSA): Explanatory note to GVP Module VII and Assessors’ questions and answers (Q&A) guidance on PSUR single assessment (PSUSA).
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Editoral Board
Editor-in-Chief:
- Phillip Leventhal (4Clinics, Lyon, France)
Co-Editor:
- Stephen Gilliver (TFS Trial Form Support, Lund, Sweden)
Managing Editor
- Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
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Associate Editors:
- Anuradha Alahari (PAREXEL International, Paris, France)
- Raquel Billiones (Clinipace, Zurich, Switzerland)
- Barbara Grossman (Hawkeye Medical Limited, Berkshire, UK)
- Joselita T Salita (Freelance, Bremen, Germany)
- Katharine Webb (INC Research, in Munich, Germany)
- Nathan Susnik (Hanover Medical School, Hanover, Germany)
Section Editors:
- Alison McIntosh (ICON Clinical Research, Hampshire, UK)
- Karin Eichele (Novartis Pharma, Nürnberg, Germany)
- Greg Morley (Freelance, Madrid, Spain)
- Wendy Kingdom (Wendy Kingdom Ltd., Dulverton, UK)
- Lisa Chamberlain-James (Trilogy Writing and Consulting, Norfolk, UK)
- Maria Koltowska-Haggstrom (Proper Medical Writing Warsaw, Poland)
- Laura Collada Ali (Teksema, Cogne, Italy)
- Simon Page (Cambridge Medical Communication Ltd, Cambridge, UK)
- Hervé Maisonneuve (Freelance, Lyon, France)
- Satyen Shenoy (Describe Scientific Writing & Communications, Cologne, Germany)
- Claire Gudex (Klinisk Institut, Odense, Denmark)
- Evguenia Alechine (Epsilon Scientific Communication, Buenos Aires, Argentina)
- Beatrix Doerr
Ad-hoc Editors:
- Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)
Editor Emeritus:
- Elise Langdon-Neuner (Medical University of Vienna, Austria)