Context:
As the landscape of clinical trials regulations in the EU and the UK evolves, pharmaceutical and biotech companies are facing challenges in understanding and adapting to the changes. Additionally, companies are encountering difficulties in effectively presenting their CMC data to ensure a successful outcome in the approval process.
This session aims to highlight some of these challenges, which are often not fully understood in this evolving climate, in order to better prepare companies for the changes. It will offer practical guidance and real-world examples to assist companies in the application process or the transition to the new regulatory framework. Furthermore, the session will explore effective strategies for presenting CMC data to increase the likelihood of successful outcomes and reduce compliance burden. By tackling these challenges head-on, this session seeks to provide attendees with the knowledge and tools necessary to navigate the regulatory environment effectively and streamline their clinical trial processes.
Speaker profile:
Dr James Parsley, Head of CMC & Principal Consultant at Scendea - James is responsible for providing global CMC biological technical and regulatory advice to Scendea’s clients from early-stage development through to marketing authorisation and post-marketing.
A former director at GSK, James has 20 years’ experience in the pharmaceutical industry with a broad regulatory background in terms of regulatory disciplines and therapeutic areas. His main expertise is in CMC biopharmaceuticals. James holds a DPhil in Biochemistry from the University of Sussex and is a member of TOPRA for which he has previously lectured on both nonclinical and CMC biopharmaceutical regulatory affairs.
This event is free to attend and open to all.
