Module 3 Presentations

07/05/2024

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

37

Change Management within CMC Functions

• Reluctance to implement new technologies and procedures due to potential regulatory and business chase impact • Quality units will evolve to be a more hands-on review of the product attributes • Ability to quickly ascertain the impact of proposed changes or deviations

“Stakeholder Management”

• High demand to understand Critical Quality Attributes (and monitor related Critical Process Parameters) at a molecular level Invest in Quality Control, best-practice analytics and procedures

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

38