About this SESSION
A decade after its launch, how has the UK’s Early Access to Medicines Scheme (EAMS) evolved, and what are the key regulatory considerations for companies looking to engage with the MHRA?
Join guest speaker Stephen Maddocks (MHRA), Kieron Lewis (Clinigen) and Natalie McGregor (Clinigen) at the virtual Clinigen Insights Conference for an in-depth discussion.
What we'll cover
- How has the UK’s Early Access to Medicines Scheme (EAMS) evolved?
- How can companies effectively engage with the MHRA?
- The key regulatory considerations.
Meet the speakers
Kieron Lewis
Director of Strategic Consulting
Kieron joined the Clinigen Group in 2014 and is responsible for consulting with Biotech And Pharmaceutical companies on Managed Access Strategies and Program efficiency. Kieron specializes in advising companies on optimal MAP development, which includes design, setup, ethical considerations, commercial considerations, and the implementation of a compliant program for unlicensed supply. Before joining Clinigen, Kieron spent 16 years in the pharmaceutical industry fulfilling a range of roles within Market Access, Medical, and Commercial functions including Head of the Cardiovascular Division at Servier Laboratories contributing to European and Global development plans.
Natalie McGregor
Regulatory Affairs Director
Natalie McGregor joined Clinigen in 2019 and is currently Senior Regulatory Affairs Manager for Clinigen's products, and works with internal and external stakeholders on the development of regulatory strategy for compliant Managed Access Programs. Prior to joining Clinigen she held a variety of Regulatory Affairs roles in the pharmaceutical and biotech industries including in clinical and medical device trials. Natalie has a PhD in Biochemistry.
Stephen Maddocks
Head of Pre-Submission Advice, MHRA
Stephen in a Medicinal Chemist with experience in chemical development within industry, with significant experience within the medicines regulator and Department of Health and Social Care. Stephen now focusses on the early identification of new technologies and advances in science that could deliver transformative treatment pathways or potential disruption to the NHS and how the MHRA can prepare for these well in advance.
Who should attend
Pharmaceutical and biotech professionals preparing for or managing a product launch
Market access, commercial, and medical affairs teams
Strategy and lifecycle planning leads
Regulatory and health economics professionals
Register to attend
Join us live or watch on demand after the event.
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