A harmonised approach to clinical data standards
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.
Patients are at the centre of everything
Yaneth Giha, Executive President, FIFARMA, finds and implements solutions to enhance patient outcomes.
Every patient has a story to tell us
Dr Francesco Pignatti, Head of Oncology and Haematology at the EMA, discusses his career, his inspirations, and why it is important to involve patients in regulatory decisions.
Digital and data-driven: information management at the EMA
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
Updates to quality legislation from the EMA
Brian Dooley, Quality Specialist in the Pharmaceutical Quality Office of the EMA, discusses his role, new marketing applications and updates to quality legislation.
Evolutions in patient healthcare at MHRA
Chief Safety Officer, Alison Cave discusses her role at the MHRA, key objectives and ambitions for the regulator.
A review of paediatric development challenges, FDA collaboration and future trends
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 ...
The national competent authorities of Belgium and Luxembourg share their views about the e-PIL Pilot
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 ...
Regulating medicines in a surge of change
RegRap speaks to Steve Hoare, Quality Regulatory Science and Safety Policy Director at the ABPI
A strong advocate for global harmonisation in animal health
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.
Building best regulatory practices in Brazil
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.
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