The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting the document, coordinating the input of the involved functions, providing valuable expertise on the required format and contents and detailed guideline knowledge, and coordinating the review and consolidation of comments. Furthermore, different submission scenarios and document requirements exist, depending upon, for example, the medicinal product, therapeutic indication, and authorisation procedure. The result should always be a high-quality state-of-the-art document meeting all requirements for an electronic submission to health authorities worldwide.
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Associate Editors
Section Editors
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk