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Institute of Medicine and National Academies of Science, and ISSCR Workshop November 18, 2013

S tem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings – A Workshop. Institute of Medicine and National Academies of Science, and ISSCR Workshop November 18, 2013.

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Institute of Medicine and National Academies of Science, and ISSCR Workshop November 18, 2013

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  1. Stem Cell Therapies: Opportunities for Assuring the Qualityand Safety of Unregulated Clinical Offerings – A Workshop Institute of Medicine and National Academies of Science, and ISSCR Workshop November 18, 2013

  2. Session II: Quality Assurance - Regulatory and legal frameworks for offering stem cell therapies • Moderator: • Ellen G. Feigal, California Institute for Regenerative Medicine • Speakers: • Margaret Foster Riley, University of Virginia School of Law - US • Paolo Bianco, Sapienza Universita di Roma – Italy • Toshio Miyata, Health and Global Policy Institute - Japan • María de Jesús Medina Arellano, Universidad Autonoma de Nayarit - Mexico • Qi Zhou, Institute of Zoology Chinese Academy of Sciences – China • Panel Discussion

  3. Questions speakers were asked to consider • Can stem cell treatments be offered without any prior approval from some entity? • If yes, how is quality assured and maintained (professional skills and quality of the materials being used)? • If no, what entity or entities must approve the treatment and what is the basis for their decision (e.g. safety, effectiveness, safety & effectiveness, truthfulness, etc)? • Is the question not answerable unless you have further details about the product? How would that information be obtained, who is responsible for making the information available? And to whom?

  4. Questions speakers were asked to consider • Can a treatment be advertised directly to consumers? • Would this depend on further details about the product? • Are there mechanisms or programs for clinics to voluntarily share information about their offerings? • Are there regulatory mechanisms for access to investigational agents outside of a clinical trial? • How are these mechanisms similar or different across countries?

  5. Session II: Quality Assurance - Regulatory and legal frameworks for offering stem cell therapies • Moderator: • Ellen G. Feigal, California Institute for Regenerative Medicine • Speakers: • Margaret Foster Riley, University of Virginia School of Law - US • Paolo Bianco, Sapienza Universita di Roma – Italy • Toshio Miyata, Health and Global Policy Institute - Japan • María de Jesús Medina Arellano, Universidad Autonoma de Nayarit - Mexico • Qi Zhou, Institute of Zoology Chinese Academy of Sciences – China • Panel Discussion

  6. Questions for panelists • Can a treatment be advertised directly to consumers? • How are patient safety and medical innovation being balanced? • How does country specific promotion of local biotech economies affect the ability to regulate clinic offerings? • How can institutional review boards and licensing bodies supplement the activities of regulatory agencies to promote the safety of patients?

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