ICH Guideline definition

ICH Guideline means the Harmonized Tripartite Guideline of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
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ICH Guideline means the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) as the same may be amended or re-issued from time to time. "Investigators" means those registered medical practitioners responsible for the conduct of Clinical Trials at Trial Sites. In the event that a Clinical Trial is conducted by a team of individuals at a Trial Site, all of the team members are Investigators and the Investigator leading the team, when referred to separately from the other Investigators, will be called the Principal Investigator. "Investigational Product" has the same meaning as it does in the ICH Guideline. "Materials" means any and all materials provided by the Sponsor to the Investigators in connection with this Agreement including but not limited to any Investigational Product. "Modification" means a major change to any Order or Service that requires a new Order to be agreed. "Order" means a request made by the Sponsor to CRO for CRO to arrange for the Services to be provided in respect of a Clinical Trial which is accepted by CRO on the terms detailed in a Clinical Trial Order in the form detailed in the Schedules One. "Proprietary Information" means:—
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Examples of ICH Guideline in a sentence

  • In the event of the occurrence of any serious adverse event(s) (as defined in ICH Guideline E2A), the Parties shall meet (in person or via telephone) within [**] of first becoming aware of such occurrence to discuss steps necessary to address any safety concerns and share any relevant information regarding such occurrence [**] Portions of this exhibit have been omitted pursuant to a confidential treatment request.

  • The agreement shall ensure that the trial is conducted and documented according to national and international laws, regulations and ICH Guideline for Good Clinical Practice (ICH GCP).

  • A serious adverse event is defined (by ICH Guideline E2A and Fed.

  • I agree to comply with the current International Conference on Harmonisation (ICH) Guideline on Good Clinical Practice (GCP), applicable laws and regulations, and the Declaration of Helsinki.

  • The procedures set out in this study protocol pertaining to the conduct, evaluation, and documentation of this study are designed to ensure that NovImmune, its authorised representative, and Investigator abide by Good Clinical Practice (GCP), as described in International Conference on Harmonization (ICH) Guideline E6 and in accordance with the general ethical principles outlined in the Declaration of Helsinki.

  • The foregoing notwithstanding, each Party may retain one (1) archival copy of the Confidential Information provided by the other Party in a limited access file for purposes of monitoring its ongoing obligations hereunder and to comply with any applicable regulatory requirements (including, but not limited to, those set forth in ICH Guideline E6GCP § 4.9.5 and 21 CFR Section 312.57).

  • An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

  • Reseller shall not acquire and shall not claim any title or rights in or to such patents, trademarks and copyrights.