2023-11-02T00:05:00+00:00By Leah Kleylein, in conversation with Dave Evans
David Evans, President and CEO of Clinical Data Interchange Standards Consortium (CDISC), speaks to the journal’s November Issue Editor Leah Kleylein to discuss his role at the helm of the standards development organisation and the ways it is advancing global data standards in the clinical research realm.
2023-04-06T07:57:00+01:00By Cristina Mota
Yaneth Giha, Executive President, FIFARMA, finds and implements solutions to enhance patient outcomes.
2022-06-22T09:58:00+01:00By Kasia Nowok
Dr Hilmar Hamann, Head of Information Management Division at the EMA, discusses key milestones in his career, the challenges faced and his long-term visions for information management legislation
Susan McCune M.D., is a paediatrician and neonatologist, with 18 years’ academic clinical and research experience. This was followed by 18 years at the US FDA where, from 2017 to 2021, she was the director of the Office of Pediatric Therapeutics in the Office of the Commissioner. She was responsible ...
A: Iris Geussens: Digitalisation is the future, and the pharmaceutical sector cannot stay behind. The advantage of an electronic package leaflet is that you always have access to the most up-to-date information. Most changes to a patient information leaflet have to do with the safety of the product. When ...
2022-02-21T08:52:00+00:00By Pascale Canning
Gavin Hall, Interim Director of Authorisations at the Veterinary Medicines Directorate, discusses the agency’s drive to harmonise scientific guidelines and its readiness to be flexible with regulatory frameworks following Brexit.
2022-01-24T10:02:00+00:00By Victoria Goff
Gustavo Mendes Lima Santos, General Manager of Medicines and Biological Products at ANVISA, explains how the agency has aligned with best practices of others across the world, and discusses important updates to legislation in Brazil.
2021-12-20T09:21:00+00:00By Leah Kleylein
The peer-reviewed journal, published 11 times per year and available free to TOPRA members.
The Organisation for Professionals in Regulatory Affairs
TOPRA Publishing, 6th Floor, 3 Harbour Exchange, South Quay, London E14 9GE, UK
Tel: +44 (0) 20 7510 2560
Blvd du Souverain 280, 1160 Brussels, Belgium
Tel: +32 (0) 2 808 72 70