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With the rules on Qualified Person release undergoing significant change, it will be important to discuss and maintain an ongoing understanding of Good Manufacturing Practice (GMP) and new legislation in order to successfully navigate the global clinical trials market and ensure the timely supply of your Investigational Medicinal Products (IMPs).
In Europe, and in the UK, the Qualified Person (QP) plays a crucial role in bringing safe and timely products to the market and/or supplying them to the clinic. There have been interesting regulatory developments in Europe– most notably the EU Clinical Trial Regulation 2022 – and it is critical for pharmaceutical companies to be up to speed with these. The UK has also just issued proposals to overhaul its clinical trial framework.
In this webinar, clinical QP experts answered numerous questions regarding QP release and gave a presentation on:
Senior Director, Quality, EMEA
Thermo Fisher Scientific
A Chartered biologist, with a Masters in Pharmaceutical Sciences, Harry has over 20 years’ industry experience in Steriles, Biologics & Solid Dose in both Commercial and Clinical Manufacturing and Packaging. Harry currently holds the position of Senior Director, Quality, EMEA, leading the EMEA Quality function across clinical services sites at Thermo Fisher Scientific. Harry previously led Quality at the Thermo Fisher Scientific Horsham site for several years. Harry is an experienced Qualified Person (QP) for clinical and commercial products.
QA Manager & Qualified Person
Thermo Fisher Scientific
Naomi currently holds the position of QA Manager & QP supervising the client liaison and auditing functions at the Thermo Fisher Scientific clinical services site at Horsham, UK. She has in-depth experience of clinical packaging and distribution of Investigational Medicinal Products (IMPs). Naomi qualified as a Qualified Person (QP) in September 2019 and has been supporting the site in various roles, including clinical project management for over 13 years. Naomi holds a Batchelors degree in Medical Biochemistry and a post graduate diploma in pharmaceutical studies. She is a full charted member of the Royal Society of Biology.
Managing Editor, Custom Content
Informa Pharma Intelligence
