Avoiding Potential Pitfalls: Phase Appropriate CMC Development and Regulatory Considerations, New Webinar Hosted by Xtalks
TORONTO (PRWEB) June 06, 2019 -- 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 XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/
Contact:
Candice Tang
Tel: +1 (416) 977-6555 ext 400
Email: ctang(at)xtalks.com
Candice Tang, Xtalks, http://www.xtalks.com, (416) 977-6555, [email protected]
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