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Wednesday, June 27 • 8:00am - 9:15am
#315: Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-634-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Evaluate post-approval changes differently and identify the best strategies to gain approval and implement changes rapidly.

Chair

Leonard Lescosky

Speaker

Compliance and Change Control: Checking that the Manufacture/CMC is Maintained in Accord with the Terms of the License
Peter Lassoff, PharmD

Changing Landscape of Managing CMC Post-Approval Changes: Challenges Now and How Global Regulations Impacts Us Going Forward
Pascha Clark-Higgs, RAC

Pharmacopoeia Harmonization and Global Compendial Compliance
J. Mark Wiggins, MS


Speakers
avatar for Pascha Clark-Higgs

Pascha Clark-Higgs

Associate Director, Regulatory Development Solutions, CMC, PPD
Pascha Clark-Higgs has over 18 years of experience within the pharmaceutical industry. Pascha has held various roles within regulatory affairs and analytical development from start-up to large pharmaceutical companies supporting development and commercialization of brand and generic... Read More →
avatar for Peter Lassoff

Peter Lassoff

Vice President and Head, Global Regulatory Affairs, IQVIA
Peter Lassoff is Vice President and Head of Global Regulatory Affairs at IQVIA. In his role, he works with global clients in the pharmaceutical, medical device, cosmetic, nutrition and other industries on regulatory strategy and implementation to ensure their products are placed on... Read More →
avatar for Leonard Lescosky

Leonard Lescosky

Vice President, CMC Regulatory Affairs, AbbVie, Inc.
Len joined AbbVie in December 2011. Len has almost 30 years of pharmaceutical experience with more than 20 in regulatory. He has held various positions at Thompson Hine LLP, Corus (Gilead), Solvay, Pfizer, Warner Lambert and Parke Davis. Len holds a law degree from Georgia State University... Read More →
avatar for J. Mark Wiggins

J. Mark Wiggins

Director, Compendial Compliance and Advocacy, Merck & Co., Inc.
J. Mark Wiggins is Director, Compendial Compliance and Advocacy at Merck, with 30 years experience in the pharmaceutical industry. His responsibilities include reviewing compendial changes from around the world to ensure ongoing compliance and establishing public quality standards... Read More →

Wednesday June 27, 2018 8:00am - 9:15am
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session