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IPRP – International Pharmaceutical Regulators Programme

WEBThe Agencies agreed to establish the Regulators Forum Gene Therapy Discussion Group (RFGTDG), allowing the continuation of the ICH GTDG’s activities in …

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URL: https://www.iprp.global/working-group/gene-therapy

Gene Therapy IPRP

WEBThe Agencies agreed to establish the Regulators Forum Gene Therapy Discussion Group (RFGTDG), allowing the continuation of the ICH GTDG’s activities in an adapted form. …

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Mandate Document Gene Therapy Working Group (GTWG)

WEB1.2. Expected Benefits The GTWG provides an international networking forum to discuss emerging scientific developments and concerns for the regulation of gene therapy products.

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IPRP – International Pharmaceutical Regulators Programme

WEBThe IPRF biosimilar working group will contribute to provide meaningful outcome to promote public health through more affordable biosimilar products. 2. Objectives. For regulatory …

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International Regulatory Frameworks for Cell and Gene …

WEB11 August 2021 3 | P a g e Country Regulatory Authority Law/Regulation Details Weblinks Canada Health Canada Food and Drugs Act R.S.C., 1985, C. F-

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IPRP – International Pharmaceutical Regulators Programme

WEBThe IPRP is the global forum of regulatory authorities and regulatory organisations at the operational level for issues related to the regulation of …

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IPRP Working Groups IPRP

WEBThe Cell Therapy Working Group (CTWG)’s primary goals are open discussion and sharing of best practices for the regulation of cell and tissue-based …

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IPRP – International Pharmaceutical Regulators Programme

WEBIPRP Working Groups. The IPRP currently comprises 8 Working Groups (WGs), whose work products can be found below. The documents produced by the IPRP WGs, which …

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IPRP – International Pharmaceutical Regulators Programme

WEBMembers & Observers. The following organisations are participating in the activities of the IPRP. edit order; add member

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Bioequivalence for Generics IPRP

WEBIn 2016, the group expanded its scope to bioequivalence and was renamed the Bioequivalence Working Group (BEWG) to reflect this development and the …

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IPRP – International Pharmaceutical Regulators Programme

WEBThe strategic priorities of the IPRP create a pathway to respond to the challenges faced by RAs. They are relevant to information sharing; facilitating collaboration towards …

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Mandate Document Nanomedicines Working Group

WEB1.2. Expected Benefits The work of this group will ultimately improve the regulation ines and nano-enabled of nanomedic medical products providing more rapid access to high …

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IPRP – International Pharmaceutical Regulators Programme

WEBThe IPRP QWG Pilot Project of Active Substance Master File (ASMF)/Drug Master File (DMF) Database

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Biopharmaceutics Classification System (BCS) Biowaiver

WEBIGDRP BCS Biowaiver Assessment Report < Drug Product name > Page 2 of 17 Version 1, 10 February 2017. In order to achieve the IPRP's objective to promote collaboration and …

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External Stakeholder Engagement Plan

WEBVersion 1.1 Approved by the IPRP MC on 2 June 2019 3 1. Inform – about IPRP MC meetings and work products, about what IPRP is and what its objectives are 2. Seek …

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1st International Generic Drug Regulators Programme

WEBThe IGDRP ASMF/DMF working group was formed in May 2013 to foster international collaboration and worksharing in the area of evaluations for ASMFs/DMFs …

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