Avoiding Potential Pitfalls: Phase Appropriate CMC Development and Regulatory Considerations, New Webinar Hosted by Xtalks
Incorporation of phase appropriate development strategies is becoming increasingly essential to manage the balance between speed, cost and completeness during development. Early considerations into Chemistry Manufacturing and Controls (CMC) and filing approaches will set up developers for later success. In this free webinar, learn how to avoid potential pitfalls and navigate regulatory requirements during CMC development.
Join Recro Gainesville experts R. Wayne Wiley, RPh, Senior Director of Regulatory Affairs and Richard Sidwell, PhD, Vice President and Chief Scientific Officer in a live webinar on Thursday, June 20, 2019 at 1 pm EDT to learn about:
- Key phase appropriate development decisions for Chemistry Manufacturing and Controls (CMC)
- The benefits of incorporating phase appropriate development principles in CMC development
- Strategies to apply phase appropriate development strategy at each stage of development
- The role of phase appropriate development in improving regulatory review outcomes
Incorporation of phase appropriate development strategies is becoming increasingly essential to manage the balance between speed, cost and completeness during development. The possibilities for both CMC development and filing approaches range from the minimalist style to a continuously supported style. The minimalist style is preparing only the things necessary for the next filing to save money and time. The continuously supported style is keeping a development program up-to-date and fully current so filings are ready to go. There are pros and cons to both styles, and while there is no right answer, there probably is a “best answer” to suit each company’s culture, funding runway, and the ultimate goal for the project.
In this webinar, participants will learn which approach will work best for their company and hear about challenges that may arise. The speakers will also touch on several case studies that will alert drug developers to (and help them avoid) potential pitfalls and late-stage gaps in their CMC development.
For more information or to register for this event, visit Avoiding Potential Pitfalls: Phase Appropriate CMC Development and Regulatory Considerations.
About Recro Gainesville
Recro Gainesville provides solid dosage form development, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market. Specializing in extended release solid dose and DEA controlled substances, Recro has the experts to deliver clients’ most complex pharmaceutical development and manufacturing projects in its best-in-class, 120,000 square feet of manufacturing space. For more information about Recro’s flexible CDMO solutions, visit www.recrogainesville.com.
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