TACKLING THE MOST PRESSING REGULATORY CMC CHALLENGES

Time: 9:00 am
day: Workshop Day - track c

Details:

• Navigating regulatory expectations after process changes, including technical regulatory strategies for successful comparability assessments
• Taking advantage of all channels available for drug sponsors to interact with the regulators
• Identifying the commonly observed CMC-related issues that have potential to lead to a clinical hold
• Identifying common pitfalls related to product characterization and manufacturing process controls
• Leveraging a risk-based approach using statistical strategies based on the impact of the change on the critical quality attribute, evolving as the gene therapy progresses through the clinic

Speakers:

Tayler shebly

Wendy Larson Wendy holds a Bachelor of Science Degree in Pharmacology, and Master of Science in Regulatory Affairs and Health Policy from Massachusetts Colleges of Pharmacy and Read more

Khandan Baradaran Khandan Baradaran, Ph.D., is Vice President and Global Head of Regulatory CMC at Ultragenyx Pharmaceutical. In this role she is responsible for multiple AAV gene Read more