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Recognition by TransCelerate BioPharma

TransCelerate BioPharma

Our ICH-GCP Training now also meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies. The organizations’ mission is to collaborate across the global R&D community to identify, prioritize, design and implement solutions designed to drive the efficient, effective and high quality delivery of innovative new therapies. TransCelerate evolved from discussions at various forums for executive R&D leadership to discuss relevant issues facing the industry and solutions for addressing common challenges. Founding members include AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi, and all have representation on the Board of Directors. Additional members include Astellas Pharma Inc., Biogen Idec, Braeburn Pharmaceuticals, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.), Onyx Pharmaceuticals, Inc., an Amgen subsidiary, and UCB.

TransCelerate members have developed guidelines to give innovative drug companies the comfort necessary to recognize and rely on another member’s or Training Provider’s investigator site personnel GCP training meeting the identified Minimum Criteria. ECCRT’s ICH-GCP training meets all these minimum criteria and is recognised by all the above companies as a training provider.

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