The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes
Leonard Lescosky, JD, MS
Vice President, CMC Regulatory Affairs
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 : Learn how to ensure that your manufacturing facility and regulatory affairs department are aligned with respect to the quality module of your products' dossiers.
Compliance and Change Control: Checking that the Manufacture/CMC is Maintained in Accord with the Terms of the License
Peter Lassoff, PharmD
Vice President and Head, Global Regulatory Affairs
IQVIA, United Kingdom
Changing Landscape of Managing CMC Post-Approval Changes: Challenges Now and How Global Regulations Impacts Us Going Forward
Pascha Clark-Higgs, RAC
Associate Director, Regulatory Development Solutions, CMC
PPD, United States
Pharmacopoeia Harmonization and Global Compendial Compliance
J. Mark Wiggins, MS
Director, Compendial Compliance and Advocacy
Merck & Co., Inc., United States