Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers
Dellepiane, Nora, Pagliusi, Sonia, Akut, Prashant, Comellas, Sebastian, De Clercq, Norbert, Ghadge, Shubhangi, Gastineau, Thierry, McGoldrick, Mic, Nurnaeni, Ida, Scheppler, Lorenz
Published in Vaccine: X (11.12.2020)
Published in Vaccine: X (11.12.2020)
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Journal Article
Regulatory Harmonization and Streamlining of Clinical Trial Applications globally should lead to faster clinical development and earlier access to life-saving vaccines
Scheppler, Lorenz, De Clercq, Norbert, McGoldrick, Mic, Dias, Jacqueline
Published in Vaccine (29.01.2021)
Published in Vaccine (29.01.2021)
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Case Studies on Changes and Proposed Process Development Approaches reflecting applicability of PDA Technical Report No. 89 Strategies for Vaccine Development and Lifecycle Management
Campa, Cristiana, Clenet, Didier, Halpern, Jane, Le Palaire, Lyne, Krishna, Mahesh, McGoldrick, Mic, Bilanin, Mihai, Pattnaik, Priyabrata, Pelt, Richard, Restrepo, Sabrina
Published in PDA journal of pharmaceutical science and technology (24.09.2024)
Published in PDA journal of pharmaceutical science and technology (24.09.2024)
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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
McGoldrick, Mic, Gastineau, Thierry, Wilkinson, Diane, Campa, Cristiana, De Clercq, Norbert, Mallia-Milanes, Andrea, Germay, Olivier, Krishnan, Jyothsna, Van Ooij, M, Thien, Michael P, Mlynarczyk, Peter J., Saltus, Edward, Wauters, Florence, Juvin, Philippe, Clenet, Didier, Basso, Ana, Dellepiane, Nora, Pagliusi, Sonia, Collaço de Moraes Stávale, Monique, Sivaramakrishnan, Venkatraman H, Desai, Samir
Published in Vaccine (23.02.2022)
Published in Vaccine (23.02.2022)
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Journal Article
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
McGoldrick, Mic, Gastineau, Thierry, Wilkinson, Diane, Campa, Cristiana, Clercq, Norbert De, Mallia-Milanes, Andrea, Germay, Olivier, Krishnan, Jyothsna, Van Ooij, M., Thien, Michael P., Mlynarczyk, Peter J., Saltus, Edward, Juvin, Philippe, Clenet, Didier, Basso, Ana, Dellepiane, Nora, Pagliusi, Sonia, de Moraes Stávale, Monique Collaço, Sivaramakrishnan, Venkatraman H., Desai, Samir
Published in Vaccine (23.02.2022)
Published in Vaccine (23.02.2022)
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Journal Article
Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical Products
Garbe, Joerg H.O, Conti, Tais, Mcgoldrick, Mic, Jacobs, Maria G, Juvin, Philippe, Mlynarczyk, Peter J, Ooij, Mark Van, Roenninger, Stephan K, Tyers, Gerald
Published in Pharmaceutical technology Europe (01.05.2024)
Published in Pharmaceutical technology Europe (01.05.2024)
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Journal Article
Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical Products
Garbe, Joerg H.O, Conti, Tais, McGoldrick, Mic, Jacobs, Maria G, Juvin, Philippe, Mlynarczyk, Peter J, Ooij, Mark van, Roenninger, Stephan, K.Tyers, Gerald
Published in Pharmaceutical Technology (01.05.2024)
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Published in Pharmaceutical Technology (01.05.2024)
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