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Understanding the basic need for Good Clinical Practice GCP

Clinical Research in Life Sciences and its Industrial Implications Workshop Bahria-HEC November 7, 2007. 2. Agenda. History Principles of ICH-GCP Institutional Review Board/Independent Ethics Committee (IRB/IEC) Investigator Sponsor. Clinical Research in Life Sciences and its Industrial Impl

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Understanding the basic need for Good Clinical Practice GCP

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    1. Understanding the basic need for Good Clinical Practice (GCP) Dr. Javed Rashid Medical Affairs Schering-Plough Pakistan

    2. Clinical Research in Life Sciences and its Industrial Implications Workshop Bahria-HEC November 7, 2007 2 Agenda History Principles of ICH-GCP Institutional Review Board/Independent Ethics Committee (IRB/IEC) Investigator Sponsor

    3. Clinical Research in Life Sciences and its Industrial Implications Workshop Bahria-HEC November 7, 2007 3 Good Clinical Practice (GCP) Derived from the International Conference on Harmonisation (ICH) of Technical Requirements for Registration ofPharmaceuticals for Human Use (Version: Step 4, 1996) U.S./European Union/Japanese collaboration to standardize practice/conduct of clinical research (other countries are joining) Results of studies accepted in one country should be accepted in other countries Based on the WMA Declaration of Helsinki 1964

    4. Clinical Research in Life Sciences and its Industrial Implications Workshop Bahria-HEC November 7, 2007 4 Good Clinical Practice (GCP) Derived from the International Conference on Harmonisation (ICH) of Technical Requirements for Registration ofPharmaceuticals for Human Use (Version: Step 4, 1996) U.S./European Union/Japanese collaboration to standardize practice/conduct of clinical research (other countries are joining) Results of studies accepted in one country should be accepted in other countries Based on the WMA Declaration of Helsinki 1964

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