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Maria G. Jacobs

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Articles by Maria G. Jacobs

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

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as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.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

ByStephan Rönninger,Karl Ennis,Joerg H.O. Garbe,Guido M. Furer,Maria G. Jacobs
August 2nd 2015
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Latest Updated 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

    May 8th 2024

  • 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

    August 2nd 2015



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