IQ Webinar: Global Dissolution Similarity Requirements - Harmonization Challenges and Opportunities
Join us from 11:00 - 12:30 PM ET on 9 April for the IQ Webinar: Global Dissolution Similarity Requirements - Harmonization Challenges and Opportunities
- Andreas Abend, Merck & Co., Inc.
- Dorys A. Diaz, Pfizer
- Connie Langer, Pfizer
- Limin Zhang, Bristol-Myers Squibb
Presented by the Dissolution Working Group
Sponsored by the IQ Analytical Leadership Group
Learn from industry thought-leaders on the current challenges and opportunities to establish dissolution similarity. Through this seminar, attendees will learn the current divergence and convergence on dissolution similarity criteria requirements across regulatory agencies. Opportunities and considerations for global harmonization as well as acceptability of other alternatives approaches and the role of similarity testing in consideration of safe-space/clinically relevant dissolution specification will be discussed. Attendees will learn key considerations on how to identify Established Conditions (EC) and how changes to those ECs will be reported, based on risk. Examples for managing changes w/wo a safe space will be shared by your industry peers.
Goals and Objectives
- Dissolution testing value to support post approval changes
- Process experience
- Product performance
- A business case for global harmonization of dissolution similarity acceptance criteria
- Regulatory application of dissolution similarity testing
- Evolving opportunities to address dissolution similarity and opportunities for global harmonization
- The role of clinically relevant dissolution specifications and safe space when “assessing the impact of change”
- Review opportunities to leverage ICH Q12 tools to assess the impact of changes.
- Provide an opportunity to get your questions on dissolution similarity answered by our panel of industry experts during in-depth, interactive Q/A session.
This webinar is open to the public. IQ membership is not required to register.