GCP Requirements definition

GCP Requirements or “Good Clinical Practices” means the then current standards for clinical trials for pharmaceuticals as required by the FDA, the TPD and the equivalent Regulatory Authority elsewhere in the Territory and as applicable, the policies and guidelines of the International Conference on Harmonization in effect for the clinical testing of pharmaceutical materials.
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GCP Requirements or “Good Clinical Practices” means the then current standards for clinical trials for pharmaceuticals as required by the FDA, the TPD and the equivalent Regulatory Authority elsewhere in the Territory and as applicable, the policies and guidelines of the International Conference on Harmonization in effect for the clinical testing of pharmaceutical materials. *Confidential Treatment Requested.
Sample 1
GCP Requirements or "Good Clinical Practices" means the then current standards for clinical trials for pharmaceuticals as required by the FDA, the TPD and the equivalent Regulatory Authority elsewhere in the Territory, and as applicable, the policies and
Sample 1

Examples of GCP Requirements in a sentence

  • Investigator signs statement that he/she will comply with 5330-1997 GCP Requirements, but nothing else found in FDA 1572.


More Definitions of GCP Requirements

GCP Requirements means the requirements and guidance in relation to GCP set out in the GCP Directive, the GCP Guidelines and the Regulations.
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Related to GCP Requirements

  • OHS Requirements means all Laws applicable to the Supply and related to occupational health or safety, and all of the City Policies that relate to occupational health or safety, and includes without limitation the WCA;

  • Listing Requirements means the Main Market Listing Requirements of Bursa Securities.

  • Program Requirements means certain minimum program entry requirements as well as ongoing program requirements, to be fulfilled by Partner, some of which are general PartnerEdge requirements, some of which are specific for the “Sell Engagement” and some of which are specific for the different “Cloud” Product Families, including, without limitation payment of the Program Fee(s), meeting certain minimum annual revenue requirements, upholding a Sell Authorization for at least one “Cloud” Product Family and other requirements as set out in detail in the PartnerEdge Program Guide and the RSPI.

  • MREL Requirements means the laws, regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities applicable to the Issuer and/or the Group, from time to time, (including any applicable transitional or grandfathering provisions), including, without limitation to the generality of the foregoing, any delegated or implementing acts (such as regulatory technical standards) adopted by the European Commission and any regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities adopted by the Federal Republic of Germany or the Republic of Italy, a relevant resolution authority or the European Banking Authority from time to time (whether or not such requirements, guidelines or policies are applied generally or specifically to the Issuer and/or the Group), as any of the preceding laws, regulations, requirements, guidelines, rules, standards, policies or interpretations may be amended, supplemented, superseded or replaced from time to time.

  • Service Requirements means the specification that the Flexibility Services must be capable of meeting, as defined in Schedule 1;

  • Minimum Requirements means the minimum requirements for available commercial structures. The minimum requirements may be found at this link: https://portlandgeneral.com/energy- choices/renewable-power/green-future-impact The minimum requirements may be updated from time to time to reflect PGE’s criteria from its latest Commission accepted renewable request for proposals.

  • Reporting Requirements As defined in Section 11.15.

  • Requirements means and include schedules, details, description, statement of technical data, performance characteristics, standards (Indian as well as International) as applicable and specified in the Contract.

  • Pretreatment requirements means any substantive or procedural requirement related to pretreatment, other than a pretreatment standard, imposed on an industrial user.

  • Privacy Requirements means all applicable Privacy Laws and all of the Acquired Companies’ policies, notices, and contractual obligations relating to the receipt, collection, compilation, use, storage, processing, sharing, safeguarding, security (technical, physical and administrative), disposal, destruction, disclosure, or transfer (including cross-border) of Personal Information.

  • Risk Retention Requirements means the credit risk retention requirements of Section 15G of the Exchange Act (15 U.S.C. §78o-11), as added by Section 941 of the Xxxx-Xxxxx Xxxx Street Reform and Consumer Protection Act.

  • Safety Requirements means Prudent Electrical Practices, CPUC General Order No. 167, Contractor Safety Program Requirements, and all applicable requirements of Law, PG&E, the Utility Distribution Company, the Transmission Provider, Governmental Approvals, the CAISO, CARB, NERC and WECC.

  • Project Requirements means the statement included in the Request for Proposal detailing the technical and other requirements of Canada which are to be met by the successful Bidder, and which are to be addressed in the Bid;

  • Relevant Requirements means all applicable Law relating to bribery, corruption and fraud, including the Bribery Act 2010 and any guidance issued by the Secretary of State for Justice pursuant to section 9 of the Bribery Act 2010;

  • Design requirements means the written description of the infrastructure facility to be procured pursuant to this article, including:

  • Minimum Balance Requirements You must maintain a minimum daily balance of $2,000.00 in your Money Market Savings account to obtain the disclosed annual percentage yield. We impose a monthly maintenance fee if the balance falls below $500 any day of the month. Basic Checking Account Rate Information: This account does not pay interest.

  • Performance Requirements The ordering entity reserves the right to inspect and verify that all deliveries are in accordance with specifications, both at the point of delivery and at the point of use. For orders that specify an “authorized party” to receive and inspect deliveries and/or installations, acceptance and inspection procedures must be performed by the” authorized party” to be considered and accepted by the ordering entity. Products inspected at the time of use are subject to refusal and return requirements for issues of quality such as defects in manufacturing and/or workmanship. Products will not be considered accepted by the ordering entity until the installation is complete for the applicable products.

  • Maintenance Requirements shall have the meaning set forth in Clause 14.2;

  • Listings Requirements means the listings requirements of the JSE from time to time;

  • Mandatory Requirements means those requirements described herein, which shall be fully satisfied in order for any Proposal to be considered by the City as a qualified Proposal.

  • JSE Listings Requirements means the Listings Requirements of the JSE applicable from time to time;

  • Certification Requirements means those requirements specified or referenced in this Agreement that you must meet in order to use and maintain the Certification Designation and use the Logo in accordance with the terms of this Agreement.

  • MREL Requirement means the minimum requirement for own funds and eligible liabilities which is or, as the case may be, will be applicable to the Issuer;

  • Operational requirements means the need to ensure that the Agency is to be operated as effectively, efficiently and economically as possible.

  • Mandatory City Requirements means those City laws set forth in the San Francisco Municipal Code, including the duly authorized rules, regulations, and guidelines implementing such laws that impose specific duties and obligations upon Contractor.

  • Data Protection Requirements means all applicable (i) Data Protection Laws, (ii) Privacy Policies and (iii) those terms of any Contracts imposing obligations on the Company or its Subsidiaries with respect to the Company’s collection, use, storage, disclosure, or cross-border transfer of Personal Data.