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    Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process by Breanne Stewart, Pirkko Lepola, Gunter F. Egger, Fahimeda Ali, Albert J. Allen, Albert J. Allen, Alysha K. Croker, Andrew J. Davidson, Pamela Dicks, Saul N. Faust, Saul N. Faust, Dionna Green, Collin Hovinga, Collin Hovinga, Agnes V. Klein, Robyn Langham, Hidefumi Nakamura, Laura Pioppo, Shiva Ramroop, Michiyo Sakiyama, Isabel Sanchez Vigil de la Villa, Junko Sato, Donna L. Snyder, Mark A. Turner, Mark A. Turner, Sarah Zaidi, Kanecia Zimmerman, Kanecia Zimmerman, Thierry Lacaze-Masmonteil

    Published 2025-02-01
    “…This work, undertaken by the Working Group (WG) on International Collaborations at the European Network of Pediatric Research at the European Medicines Agency (Enpr-EMA) aims to describe the research ethics review requirements including any pediatric specific requirements, as well as current or upcoming changes across six jurisdictions – the European Union (EU), United Kingdom (UK), United States of America (USA), Canada, Japan, and Australia.MethodsAn open questionnaire developed by the WG and directed at both the Competent Authorities (CA) and the national pediatric clinical trial networks arranged by jurisdictions.ResultsA synopsis of the current regulatory requirements covers centralized versus independent review, comparisons between investigator initiated and industry sponsored clinical trials, timelines, review board members requirements and the consenting/assent process for clinical trial (CT) applications, application submission processes and application requirements for each of the six jurisdictions. …”
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  4. 144

    Issues of Legal Regulation of Applying Coercive Measures of Medical Nature in International and Legal Acts and Legislation of Certain Foreign Countries by D. V. Turenko

    Published 2021-03-01
    “…Besides, the author has studied national theoretical issues of criminal law and criminal proceedings, as well as applied issues in this area of the research within law-enforcement activities of pre-trial investigation and inquiry agencies, prosecutor’s office and, in particular, procedural commissioners of pre-trial investigation. …”
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