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as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.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: October 28th 2024 | Updated: November 23rd 2024
Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development
Published: November 6th 2024 | Updated: November 23rd 2024
Automate Aseptic Filling: Closing the System at Full Modularity
Published: November 5th 2024 | Updated: November 23rd 2024
Untethered Data: Unifying and Contextualizing Drug Discovery Data
Published: November 8th 2024 | Updated: November 23rd 2024
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification
