返回 Agenda
Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes
Session Chair(s)
Leonard Lescosky, JD, MS
Vice President, Regulatory Operations and CMC
AbbVie, Inc., United States
This interactive discussion will take on the complex problem of managing global post-approval CMC changes. Countries and regions have specific timelines for review an approval of changes, and it's not just approval we need, it's approval in the right order to make implementation of the change worthwhile.
Learning Objective : Evaluate post-approval changes differently and identify the best strategies to gain approval and implement changes rapidly.
Speaker(s)
Compliance and Change Control: Checking that the Manufacture/CMC is Maintained in Accord with the Terms of the License
Peter Lassoff, PHARMD, RPH
Syneos Health, United Kingdom
Senior Vice President, Head of Regulatory, Medical Writing and Regulatory Intell
Changing Landscape of Managing CMC Post-Approval Changes: Challenges Now and How Global Regulations Impacts Us Going Forward
Pascha Clark-Higgs, RAC
PPD, United States
Associate Director, Regulatory Development Solutions, CMC
Pharmacopoeia Harmonization and Global Compendial Compliance
J. Mark Wiggins, MS
Global Pharmacopoeia Solutions LLC, United States
Owner and Compendial Consultant