Good Pharmacovigilance Practices definition

Good Pharmacovigilance Practices or “GVP” means the then-current good pharmacovigilance practice standards, practices, and procedures promulgated or endorsed by any applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time to time.

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Good Pharmacovigilance Practices or “GPV” means all applicable good pharmacovigilance practices promulgated and published by FDA, EMA or any other Regulatory Authorities having jurisdiction over the Development, Manufacture or Commercialization of INTASYL PH-762 , DP TIL, or the Product, as applicable, pursuant to its regulations, guidelines or otherwise, including as applicable, major pharmacovigilance process and product and/or population specific considerations as defined in (a) European Commission Regulation code relating to medicinal products for human use, Directives 2010/84/EU and 2012/26/EU respectively, as well as by the Commission Implementing Regulation (EU) No 520/2012 on the Performance of Pharmacovigilance Activities Provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC, Title IX of the Directive, Article 108a (a) of Directive 2001/83/EC, and principles detailed in the ICH guidelines for pharmacovigilance as well as (b) principles detailed in the United States 21 CFR and Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiological Assessment.

Good Pharmacovigilance Practices means a set of guidelines for the conduct of pharmacovigilance in the EU, drawn up based on Article 108a of Directive 2001/83/EC, by the European Medicines Agency in cooperation with competent authorities in Member States and interested parties, and applying to marketing authorization holders in the EU or the Territory.

Examples of Good Pharmacovigilance Practices in a sentence

Pharmacovigilance Each Party will be responsible to do their part to ensure patient safety, to meet all local and national regulatory requirements and to generally comply with current international guidelines for Good Pharmacovigilance Practices as promulgated by the World Health Organisation (“WHO”).
The Definitions below are derived from the current Good Pharmacovigilance Practices (GVP).
During the Term, each Party shall notify the other Party regarding all Serious Adverse Events arising in any Clinical Trials of any Product or Non-Systemic Ophthalmology Product, all adverse drug reactions (i.e. Adverse Events that are related to a Product or Non-Systemic Ophthalmology Product), and all special case scenarios, as outlined in the EMA’s Guideline on Good Pharmacovigilance Practices, Module VI, as individual cases within the timelines specified in the SDEA.
For drugs, definitions, time frames for safety data exchange and regulatory reporting are based upon current Good Pharmacovigilance Practices (GVP) for the European Union which brings together general guidance on the requirements, procedures, roles and activities for Marketing Authorization Holders (MAH) and incorporates current international agreements reached within the framework of the International Conference on Harmonization (ICH) for the electronic exchange of pharmacovigilance information.
Name: Dr.Huaizheng Peng Title: Director Signature: Date: Place: Name: ▇▇▇▇▇ ▇▇▇▇▇▇ Title: General Manager Signature: Date: Place: Name: ▇▇▇▇▇ ▇▇▇▇▇▇-DAVESNE Title: EU-QPPV, Case Management Manager Signature: Date: Place: PRODUCT ACTIVE SUBSTANCE DOSE FORM LOCAL STATUS BIOFLOR Saccharomyces Boulardii 250mg Capsule Drug BIOFLOR Saccharomyces Boulardii 250mg Sachet Drug The Definitions below are derived from the current Good Pharmacovigilance Practices (GVP).

More Definitions of Good Pharmacovigilance Practices

Good Pharmacovigilance Practices or “cGPvP” means the then-current good pharmacovigilance practices recommended by the FDA, EMA (including Volume 9A of The Rules Governing Medicinal Products in the European Union — Guidelines on Pharmacovigilance for Medicinal Products for Human Use), or other Regulatory Authority applicable to the Licensed Territory, as they may be updated from time to time, including applicable guidelines under the ICH.

Good Pharmacovigilance Practices or “GVP” means, in addition to the provisions under the Pharmacovigilance Agreement, all applicable good pharmacovigilance practices promulgated and published by the FDA, EMA or any other applicable Regulatory Authority including, as applicable, major pharmacovigilance process and product and/or population specific considerations as defined in (a) European Commission Regulation code relating to medicinal products for human use, Directives 2010/84/EU and 2012/26/EU, as well as by the Commission Implementing Regulation (EU) No 520/2012 on the Performance of Pharmacovigilance Activities provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC, Title IX and Article 108a(a) and principles detailed in the ICH guidelines for pharmacovigilance as well as (b) principles detailed in the United States 21 CFR and Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiological Assessment.

Good Pharmacovigilance Practices or “GVP” means, in addition to the provisions under the Pharmacovigilance