GCP definition

GCP means the Good Clinical Practices officially published by EMA, FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are applicable to the testing of the Compounds.

GCP means the international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. In the United States, GCP shall be based on Good Clinical Practices established through FDA guidances (including ICH E6).

GCP or “Good Clinical Practices” means the then-current standards, practices and procedures promulgated or endorsed by the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures promulgated by the EMA or other Regulatory Authority applicable to the Territory, as they may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

Examples of GCP in a sentence

• Until the Parties enter into the Pharmacovigilance Agreement, the Parties will (and will cause their Affiliates and Sublicensees to) exchange any and all relevant safety data relating to the Licensed Products within reasonably appropriate timeframes and in a reasonably appropriate format to ensure compliance with the reporting requirements of any applicable Regulatory Authority and applicable law (including GCP, GLP, and GMP, as applicable).

• Such Party will maintain all permits, licenses, registrations, and other forms of authorizations and approvals from any governmental authority or Regulatory Authority that are necessary or required to be obtained or maintained by such Party in order for such Party to perform its obligations hereunder in a manner which complies with all applicable law (including GCP, GLP, and GMP, as applicable).

• GenFleet and its Affiliates have conducted, and, to GenFleet’s knowledge, their respective contractors and consultants have conducted prior to such date all Exploitation of the Compounds and Products in accordance with all applicable law, including GLP, GCP, and GMP (as applicable) and applicable local and other anti-corruption or anti-bribery laws (including, as applicable, the provisions of the FCPA, the U.K. Anti-Bribery Act, and the Anti- Corruption Act of the PRC).

• Without limiting the foregoing, GenFleet will provide to Verastem all documentation relating to pre-clinical and Clinical Trials with respect to the Licensed Compounds and Licensed Products, including all necessary documentation attesting to GenFleet’s (or its Affiliates’ or Sublicensees’) compliance with GCP, GLP, and GMP filing requirements in the Territory or the Retained Territory, on a schedule required to meet Verastem’s applicable submission timelines.

• No decision of the JSC, any Subcommittee, or a Party via exercise of its final decision-making authority will be in contravention of the terms of this Agreement or applicable law (including, as applicable, GCP, GLP, or GMP).

More Definitions of GCP

GCP means good clinical practices, which are the then-current standards for Clinical Trials for pharmaceuticals, as set forth in the FD&C Act or other Applicable Law, and such standards of good clinical practice as are required by the Regulatory Authorities of Europe and other organizations and governmental authorities in countries for which the applicable Licensed Agent or Product is intended to be Developed, to the extent such standards are not less stringent than United States standards.

GCP means current Good Clinical Practices as specified in the United States Code of Federal Regulations, at the time of testing, and all FDA and ICH guidelines, including the ICH Consolidated Guidelines on Good Clinical Practices.

GCP means the then-current good clinical practice standards, practices, and procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time-to-time.

GCP means the current Good Clinical Practice standards for clinical trials for pharmaceuticals, as set forth in the Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by the regulatory authorities of the organizations and governmental agencies in countries in which Drug Products (as defined in the License Agreement) are intended to be sold.

GCP means the then current “good clinical practices” as such term is defined from time to time by the FDA, EMA or other Regulatory Authority of competent jurisdiction pursuant to its regulations, guidelines or otherwise, as applicable.

GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws in the region in the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

GCP means the General Conditions of Purchase contained in this section.