Current Good Clinical Practice definition

Current Good Clinical Practice means clinical practice as set out in: (i) current Guidelines for Good Clinical Practice for Trials on Medicinal Products in the European Union; (ii) US Code of Federal Regulations Title 21, Chapter 50 (Protection of Human Subjects), Chapter 56 (Institutional Review Boards), and relevant final FDA Guidance and Points to Consider for drugs and/or biotechnology-derived products, as may be amended from time to time; or (iii) the equivalent current law or regulation in any market.
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Current Good Clinical Practice or "cGCP" shall mean the current guidelines for the principles of good clinical practice in the conduct of clinical trials on medicinal products for human use as set out in EU Directive 2001/20/EC and US Guidance for Industry E6 Good Clinical Practice so far as the same are relevant in each case as amended and updated from time to time;
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Current Good Clinical Practice means clinical practice as set out in:
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Examples of Current Good Clinical Practice in a sentence

  • SuperGen shall ensure that the development activities it undertakes pursuant to Article 3 and Article 4 hereof shall be carried out in accordance with Current Good Clinical Practice, Current Good Laboratory Practice and Current Good Manufacturing Practice.

  • The parties shall appoint a mutually acceptable third party independent clinical research organization to conduct a Current Good Clinical Practice audit of the clinical development activities (a "GCP Audit").

  • Both Parties shall ensure that the development activities undertaken pursuant to Article 3 and Article 4 hereof shall be carried out in accordance with Current Good Clinical Practice, Current Good Laboratory Practice and Current Good Manufacturing Practice.

  • The parties shall appoint a mutually acceptable 15 <PAGE> CONFIDENTIAL TREATMENT REQUESTED third party independent clinical research organization to conduct a Current Good Clinical Practice audit of the clinical development activities set forth herein in each of June 2000 and December 2000 (each, a "GCP Audit").

  • The parties shall appoint a mutually acceptable third party independent clinical research organization to conduct a Current Good Clinical Practice audit of the clinical development activities set forth herein in each of [________________________] and [________________________] (each, a "GCP Audit").


More Definitions of Current Good Clinical Practice

Current Good Clinical Practice or “cGCP” means the then-current standards for clinical trials for pharmaceuticals, as set forth in the relevant FDA regulations relating to good clinical practice and clinical trials, or equivalent Laws, rules or regulations of an applicable Regulatory Authority, at the time of the clinical trials.
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Current Good Clinical Practice means the applicable then-current standards for clinical activities for pharmaceuticals or biologicals, as set forth in the Act and any regulations or guidance documents promulgated thereunder, as amended from time to time, together with, with respect to work performed in a country other than the United States, any similar standards of good clinical practice as are required by any Regulatory Authority in such country. 1.18 “cGLP” or “current Good Laboratory Practice” means the applicable then- current standards for laboratory activities for pharmaceuticals or biologicals, as set forth in the Act -4- [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED
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Current Good Clinical Practice means the applicable current good clinical practices promulgated by the FDA or other applicable Regulatory Agency in any region or country other than the United States, including any applicable requirements of Title 21 of the Code of Federal Regulations.
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