'UK Regulatory Landscape Post-Brexit' with Malgorzata Sypniewska
Topics:
- Brexit and Northern Ireland Protocol
- PV requirements including PSUR
- Establishment of MAH and Marketing Authorisation types
- MHRA’s adjustment of regulatory pathways following Brexit
- UK requirements vs EU- similarities and exceptions
- Windsor Framework
- New IRAS (Integrated Research Application System) for clinical trials
- Regulatory Connect
- Q&A
Biography:
Malgorzata is a qualified pharmacist with 10+ years of experience. She worked in Polish and Irish community pharmacies prior to stepping into a pharmaceutical industry. In 2015 she joined a Clinical Research Organization (CRO) as a Medical Information and Pharmacovigilance Specialist, and throughout the years of working on diverse range of projects she has gained skills and expertise which led her to become a Global Senior Regulatory Affairs Manager.
