With Phase 1 negotiations for the UK’s exit from the European Union complete, examining how well prepared your clinical supply operations are to ensure continuity of supply post-Brexit is highly advisable. Brexit preparation is not just for sponsors with studies already underway in the UK and EU.
Sponsors planning future studies in these regions can benefit from early evaluation and supply chain planning as well. One of the aspects of clinical supply most likely to be significantly impacted by Brexit centers around the Qualified Person batch certification of supplies that need to traverse from the UK to the EU and vice-versa.
In this webinar, we will explore how Brexit may change the working relationship between Qualified Persons (QPs) in the UK, EU and beyond through a moderated Q&A roundtable. QPs from the UK, EU and Switzerland will exchange ideas and discuss in a how they will work together including what processes will be necessary and what their requirements from the other would be post-Brexit, based on the progress of current political discussions between UK and the European Commission whose impact on the resulting relationships between UK and EU is not yet predictable.
This webinar is a rare opportunity to hear first-hand how the challenges around quality may be addressed from the very professionals responsible for upholding these quality standards, considering different post-Brexit scenarios.
Moderating the webinar will be Rebecca Stanbrook, ISPE EU IP Steering Committee member and Global Head Compliance and Regulatory Affairs Quality, Novartis AG.
Registrants are encouraged to submit questions in advance of the webinar via email to amy.lombardi@catalent.com so that our moderator and panelists can tailor the discussion to your needs.
Moderator: Rebecca Stanbrook, ISPE EU IP Steering Committee Member Global Health of Compliance and Regulatory Affairs Quality, Novartis AG.
Rebecca Stanbrook is Global Head, Drug Development Quality, Compliance and Regulatory Affairs. In this role she is responsible for the GXP operational compliance program activities and initiatives of Novartis. She has been based in the Basel Headquarters since May 2014. Prior to joining Novartis, Rebecca was Group Manager, Inspections (GLP/GCP/PV) at the Medicines and Healthcare products Regulatory Agency (MHRA). Since she joined the Agency in 2003, Rebecca held a number of positions within the fields of GCP and Pharmacovigilance. She helped shape the GCP and Pharmacovigilance statutory programmes in their early stages and was a member of one of the teams conducting the first statutory GCP inspections in the UK. She has been actively involved in the Health Research Authority project looking at a unified approvals process and proportionate standards of compliance and inspection. She is a pharmacist by profession and holds a Diploma in Research Quality Assurance. Rebecca's group at the Agency wrote the Good Clinical Practice Guide and the Good Pharmacovigilance Guide.
Lynne Byers,
NSF Executive Director
Lynne is currently an Executive Director at NSF. Her former roles include Global Head (VP) Quality in Novartis and GSK. She also worked as Head of Inspectorate at the MHRA. She is a GMP expert in European regulations, with interest in the GCP and PV interfaces with GMP. Part of her current role is keeping a close watching brief on the impact of BREXIT on the pharmaceutical QA activities and advising clients on its impact.
Pete Young, Director, Quality & Qualified Person (UK)
Mr. Young is the Quality Director at the Catalent Pharma Solutions Bolton, UK facility, in this role he has overall responsibility for Quality at the site which packages and imports investigational, unlicensed and commercial products. Mr. Young has over 20 years’ experience in the industry with prior roles in laboratories, production support and quality systems where he has led facilities upgrades and system deployments. In his current role he has hosted several regulatory inspections from the MHRA, FDA, Anvisa, SFDA and HSA. Mr. Young is a Chemist by training with further education in Environmental Analytical Science and Industrial Pharmaceutical Studies, he is also a IMP QP.
Susanne Mehlhorn, Clinical Quality Batch Processing Manager & Qualified Person (DE)
Ms. Mehlhorn is a Batch Processing Manager at the Catalent Pharma Solutions Schorndorf, Germany facility, where she is responsible for the release of clinical trials materials into the EU. Prior to Catalent, she held quality roles at Ferring Pharmaceuticals, AbbVie and its predecessor, Abbott Laboratories. She is a Qualified Person and holds a Master of Healthcare Administration, Contracting and Management from Frankfort University and a degree in Pharmaceutical Sciences from Martin Luther University of Halle-Wittenberg.
- Understand current state of Brexit negotiations and the possible impact of various scenarios on the movement of clinical supplies between the UK and EU
- Explore the current and potential future working relationship between UK and EU based QPs
- Explore potential challenges and practical solutions to uphold quality standards post-Brexit
- Clinical Operations
- Clinical Supply
- Supply Chain
- Research & Development
- Quality
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