GCP definition

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 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.

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.

Examples of GCP in a sentence

• If it is acceptable the employment of exponential space, we can compute the values for s(W ) (of the exclusion/inclusion formula in the previous section) by filling up a table s : 2Cr × {0, 1, 2,..., q} → N where after having imposed an arbitrary order on the critical pairs CP = {cp1, cp2,..., cpq}, the value s(W, i) is the number of maximal directed acyclic induced subgraphs of GCP which do not contain any node in W and all the nodes in {cpi+1, cpi+2,..., cpq}\ W .

• This process can be done also when there is more than one equivalence class of twin nodes hence, if τ1,..., τl are the size of all these different equivalence classes, the enumer- ation of directed acyclic subgraphs will run on a GCP with q − Σl τi(τi − 1) critical pairs.

• We have seen in Section 1.7.1 that there is a relation between maximal directed acyclic induced subgraphs of GCP and linear extension of P based on the critical pairs they reverse.

• We have seen in Section 1.7.1 that there exists a realizer of P of size k if there exists a directed maximal acyclic cover of GCP of size k.

• Řešitelské centrum je povinno o studii vést úplné a správné záznamy a tyto záznamy vzniklé ze studie archivovat v souladu s ICH GCP po dobu stanovenou příslušnými právními předpisy.

More Definitions of GCP

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 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 Products.

GCP means the applicable ethical, scientific, and quality standards required by applicable Regulatory Authorities for designing, conducting, recording, and reporting trials that involve the participation of human subjects, including as set forth in FDA regulations in 21 C.F.R. Parts 11, 50, 54, 56, and 312 and all related FDA rules, regulations, and orders, and by the International Conference on Harmonization E6: Good Clinical Practices Consolidated Guideline (the “ICH Guidelines”), or as otherwise required by applicable Law.

GCP means the applicable then-current good clinical practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Parts 312, 50, 54, and 56 (or such other foreign equivalent regulatory standards in any other country or jurisdiction).

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 the General Conditions of Purchase contained in this section.

GCP means the then current standards for clinical trials for pharmaceuticals, as set forth in the United States Code of Federal Regulations, ICH guidelines and applicable regulations, laws or rules as promulgated thereunder.