Thursday 7th December 2023
Regulatory Hot Topics VIII
Royal Society of Chemistry, London
This symposium will address an introduction to the issues and challenges associated with use of biowaivers. Additional topics will cover UK and international Recognition & Reliance regulatory procedures as well as updated, new and emerging ICH guidance from this year and a look forward into 2024.

This excellent opportunity for dialogue, discussion and debate with speakers and the peer group in an open forum where delegates will be able to understand, interpret and translate into day-to-day practice the guidance on our 2023 key topics:
- Biowaivers - background and case studies will be presented highlighting key differences in their use between countries
- British Pharmacopoeia topic updates from 2023
- Recognition & Reliance regulatory procedures - MHRA update on UK Recognition procedures and update around global reliance and/or accelerated processes
- ICH guidance news and updates from 2023 and looking forward into 2024 topics

This meeting encourages the potential for delegates to learn from expert speakers involved in the development of the guidance and best practice in challenging subject areas.

The event will be in-person only, at RSC, London.

Speakers:
Rabiea Abdullah - Consultant
Dr Leonard Both - MHRA
Neil Clayton - Pfizer
Peter Crowley - MHRA
Dr Helena Engman - AstraZeneca
Dr Lisa Hinchliffe - Regulatory CMC Consultant
Dr Adele Patterson - Bristol-Myers Squibb
Dr Melanie Pires - Senior Consultant, NDA Group
Priti Shah - AstraZeneca