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12 results on '"Gastineau, Thierry"'

3. Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report

Author

Viviani, Laura, Reid, Kirsty, Gastineau, Thierry, Milne, Catherine, Smith, Dean, Levis, Robin, Lei, Dianliang, van Ooij, Mark, Gilbert, Philippe Alexandre, Vandeputte, Joris, Xie, Jianxun, Madhuri, Leena, Shaid, Shahjahan, Kubiak, Vaughn, Suri, Rajinder, Mizukami, Takuo, Shirasaki, Yoshihisa, Li, Xiantang, Zhou, Ying-Ying, Trapkova, Alla, Goel, Sunil, Prakash, Jai, Subagio, Amrullah Aninditio, Suwarni, Eniek, Jung, Kyung Jin, Sanyal, Gautam, Das, Pradip, Coppens, Emmanuelle, Wright, David, Peng, Zhechu, Northeved, Helle, Jungbäck, Carmen, Kirpitchenok, Tatiana, Del Pace, Lorenzo, Seo, Borami, Poojary, Brinda, and Ottoni, Antoniana

Published
2022
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4. Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference Standard

Author

Beckers, Marie-Claire, Collete, Delphine, Barthuet, Julie, and Gastineau, Thierry

Subjects
Regulatory compliance -- Evaluation, Pharmaceutical industry -- Quality management, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Abstract

Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based [...]

Published
2022

5. Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference Standard: Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach

Author

Beckers, Marie-Claire, Collete, Delphine, Barthuet, Julie, and Gastineau, Thierry

Subjects
Drugs -- Production processes -- Standards -- Labeling, Product quality -- Standards, Pharmaceutical industry -- Production management -- Quality management -- Standards, Software quality, Product defect/failure, Business, Pharmaceuticals and cosmetics industries
Abstract

The International Council for Har-monisation's (ICH's) Q10, Pharmaceutical Quality System, Annex 1 describes potential opportunities to enhance science and risk-based regulatory approaches to post-approval changes (PACs) as follows: when a [...]

Published
2022

8. Path Forward to Optimise Post-approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide

Author

Deavin, Andrew, primary, Adam, Sarah, additional, Ausborn, Susanne, additional, Nielsen, Ane Sofie Böhm, additional, Cappellini, Sonia, additional, Colmagne-Poulard, Isabelle, additional, Gastineau, Thierry, additional, Gonzalez-Martinez, Arturo, additional, Meillerais, Sylvie, additional, and Mortazavi, Charlie, additional

Published
2022
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9. How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation

Author

McGoldrick, Mic, primary, Gastineau, Thierry, additional, Wilkinson, Diane, additional, Campa, Cristiana, additional, Clercq, Norbert De, additional, Mallia-Milanes, Andrea, additional, Germay, Olivier, additional, Krishnan, Jyothsna, additional, Van Ooij, M., additional, Thien, Michael P., additional, Mlynarczyk, Peter J., additional, Saltus, Edward, additional, Juvin, Philippe, additional, Clenet, Didier, additional, Basso, Ana, additional, Dellepiane, Nora, additional, Pagliusi, Sonia, additional, de Moraes Stávale, Monique Collaço, additional, Sivaramakrishnan, Venkatraman H., additional, and Desai, Samir, additional

Published
2022
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10. How to accelerate the supply of vaccines to all populations worldwide? Part II: Initial industry lessons learned and detailed technical reflections leveraging the COVID-19 situation

Author

McGoldrick, Mic, primary, Gastineau, Thierry, additional, Wilkinson, Diane, additional, Campa, Cristiana, additional, De Clercq, Norbert, additional, Mallia-Milanes, Andrea, additional, Germay, Olivier, additional, Krishnan, Jyothsna, additional, Van Ooij, M, additional, Thien, Michael P, additional, Mlynarczyk, Peter J., additional, Saltus, Edward, additional, Wauters, Florence, additional, Juvin, Philippe, additional, Clenet, Didier, additional, Basso, Ana, additional, Dellepiane, Nora, additional, Pagliusi, Sonia, additional, Collaço de Moraes Stávale, Monique, additional, Sivaramakrishnan, Venkatraman H, additional, and Desai, Samir, additional

Published
2022
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12. Worldwide Regulatory Reliance: Launching a Pilot on a Chemistry, Manufacturing, and Control Post Approval Change for a Vaccine.

Author

Gastineau T, Ban C, Basso A, Brehme F, Silva AL, Faure O, Palaire LL, Persaud P, and Rodriguez H

Subjects
Pilot Projects, Humans, Vaccines, World Health Organization, Drug Industry legislation & jurisprudence, Drug Industry standards, Product Surveillance, Postmarketing, Drug Approval legislation & jurisprudence
Abstract

When an initial marketing authorization of a pharmaceutical product is granted, a substantial number of chemistry, manufacturing, and control (CMC) post approval changes (PACs) have to be managed by the manufacturers. Despite efforts undertaken over the years by multiple regulatory jurisdictions, there is still heterogeneity in terms of regulatory requirements and timelines across national regulatory authorities (NRAs). This creates complexity in managing global CMC PACs, putting the supply of medical products at risk. Regulators have developed regulatory mechanisms that aim at accelerating the reviews and approvals of PACs by NRAs. The World Health Organization (WHO) is supporting the concept of "reliance" among NRAs, which are encouraged to rely on the assessment completed by a "highly performing authority". The objective is to accelerate the overall process for PACs, ultimately fostering more equitable and timely access to medical products for populations who need them. With the support of Health Canada, WHO, Pan American Health Organization, and the Paul-Ehrlich-Institut, Sanofi has launched a pilot using the principles of reliance for a CMC PAC for a vaccine, with 21 NRAs who accepted to participate in the pilot. The objective of this pilot was to apply these principles to reduce the approval timeline to a maximum of 6 months in all countries after an initial approval is granted by a reference authority. We discuss the opportunities and challenges of implementing reliance principles for CMC PACs. We also describe the pilot experience by sharing initial lessons learned from the Step 1 of this pilot, which consisted of engaging the reference authority and the NRAs., (© PDA, Inc. 2024.)

Published
2024
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