On-demand Sponsored Webcast: Planning for a Successful Initial IND and Moving Beyond: Regulatory CMC Considerations for Biotherapeutics and Cell and Gene Therapies (On-Demand)
Member: $0 | NonMember: $25
This is an On-demand recording from September 2023.
For biotherapeutics, including cell and gene therapies, strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle. For early-phase sponsors looking to successfully move from benchtop to a manufacturing facility or mid-phase programs implementing process, product, and facility changes, the planning of manufacturing, comparability, and analytical programs is crucial to reducing regulatory risk. In this webinar, Veristat Regulatory CMC experts discuss key challenges, strategies, and considerations to ensure the effective development of an analytical program to demonstrate comparability.
Registration Fees
Free
Learning Objectives
- Focus on biotherapeutics, including cell and gene therapies
- Demonstrating comparability in early to mid-phase development
- Analytical methods, including common challenges, strategies, and considerations
- Case studies and real-world insights
Audience Learning Level
Intermediate
Who Should Attend?
- Regulatory affairs professionals
- Quality Assurance Managers and Engineers
- Product Development and Design Engineers
- Human Factors and Usability Engineers
- Program and Project Managers
Speakers
Kevin Hennegan
Director of US Regulatory Affairs, Veristat
