Hyatt Regency Bethesda
1 Bethesda Metro Center
Bethesda, MD 20814
The FDA and PDA are co-sponsoring a conference to identify best practices for global development and approval for biosimilars, including:
- Risk-based approaches to setting product specifications for quality attributes.
- Practical solutions for establishing suitable control strategies over the biosimilar product lifecycle.
- Approaches for global post-marketing change control.
- Expectations for demonstrating analytical similarity.
Goals and Objectives:
- Provide a forum for open discussion between industry, academia, regulatory agencies, and other stakeholders.
- Seek feedback on best practices for risk-based approaches to setting product specifications for tier 1 and 2 quality attributes.
- Map out priorities for control strategies over the biosimilar product lifecycle.
- Accelerate the development and review of biosimilars.
- Ensure that leading experts in biological products and biosimilars have an opportunity to discuss current Agency expectations for approval for biosimilars.
Who should attend?
This conference is intended for a diverse group including:
- Scientists, clinicians, regulatory, and quality personnel, responsible for the evaluation of safety and efficacy of biosimilars;
- Parties interested in ongoing efforts on research and development of biosimilars;
- Program officers from agencies such as FDA, NIH, and CMS and their global counterparts.
To register to attend this event, visit the event registration page: PDA/FDA Biosimilars Conference
Andrea Chamblee at Andrea.firstname.lastname@example.org