Mic McGoldrick
Mic McGoldrick is director CMC Technical Advocacy and Policy, Merck Sharp and Dohme, LLC, Horsham, PA, USA.
Articles
Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical Products
Joerg H.O. Garbe;Tais Conti;Mic McGoldrick;Maria G. Jacobs;Philippe Juvin;Peter J. Mlynarczyk;Mark van Ooij;Stephan K. Roenninger;Gerald Tyers
May 8th 2024This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
Latest Updated Articles
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Published: August 21st 2024 | Updated: December 26th 2024
Pharmaceutical Technology Editorial Advisory Board
Published: November 25th 2024 | Updated: December 26th 2024
Leveraging Integrated Patient-Centric Innovations When Developing Today’s Biologics
Published: December 20th 2024 | Updated: December 26th 2024
Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development
Published: February 23rd 2024 | Updated: December 26th 2024
Europa Perspectives: Helping to Navigate the Regulatory System
