Tais Conti
Tais Conti is quality unit lead and technical director, Bristol Myers Squibb, São Paulo, Brazil.
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as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.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: February 23rd 2024 | Updated: December 22nd 2024
Europa Perspectives: Helping to Navigate the Regulatory System
Published: December 13th 2024 | Updated: December 22nd 2024
FDA Creates CDER Center for Real-World Evidence Innovation
Published: December 5th 2024 | Updated: December 22nd 2024
Leveraging Advancements in Bioanalytical Testing
Published: December 7th 2024 | Updated: December 22nd 2024
Exploring Opportunities for LNP Delivery in mRNA
