Module 3 2019

A Look into the Future of Pharmaceutical Quality Scientific Advancements vs. Regulations

• Complex therapies come with new challenges in ensuring the quality/safety of these products • Quality regulations, and industry, may have to continually adapt to address these challenges • New quality regulations have been developed to address the complex nature of e.g. biologics/ ATMPs with specific quality requirements RA Evolving

• Science has already outpaced quality regulations • Quality regulations are likely to be required to keep up with the development of new advanced therapies and new technologies

CMC Project Management

The Organisation for Professionals in Regulatory Affairs