Maria G. Jacobs

home / authors / maria-g-jacobs

Articles

Erledigte Aufgaben werden auf einer To-Do-Liste abgehakt | Image Credit: © Ralf Geithe - Stock.Adobe.com

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 2024

This 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as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

Import Testing of Pharmaceutical Products Has Limited Safety Benefits and Can Add Risk to Patients

Import Testing of Pharmaceutical Products Has Limited Safety Benefits and Can Add Risk to Patients

Stephan Rönninger;Karl Ennis;Joerg H.O. Garbe;Guido M. Furer;Maria G. Jacobs
August 2nd 2015

Latest Updated Articles

Buy, Sell, Hold: Cell and Gene Therapy
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Operator work on infusion pharmaceutical industry | Image Credit: © xmagics - © xmagics - stock.adobe.com
Published: November 6th 2024 | Updated: November 20th 2024
Automate Aseptic Filling: Closing the System at Full Modularity
Two scientists wearing lab coats and safety glasses analyzing data displayed on a computer screen in a laboratory setting | Image Credit: © NCST Studio - © NCST Studio - stock.adobe.com
Published: November 5th 2024 | Updated: November 20th 2024
Untethered Data: Unifying and Contextualizing Drug Discovery Data
Medium shot of female process supervisor in lab coat pointing at equipment controlling production quality with African American male manufacturing technician, working in protective suit at factory | Image Credit: © Seventyfour - © Seventyfour - stock.adobe.com
Published: November 8th 2024 | Updated: November 20th 2024
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification
Man touching a knowledge sharing concept | Image Credit: ©thodonal - stock.adobe.com
Published: November 4th 2024 | Updated: November 20th 2024
Strategies for Overcoming Common Challenges in Tech Transfer