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International Regulatory Harmonization Amid Globalization of Drug Development Workshop Summary (2013) / Chapter Skim
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Appendix A: Workshop Agenda
Pages 79-90

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From page 79...
... Moreover, biopharmaceutical companies seeking global markets face requirements for regulatory submissions for the same product in numerous international jurisdictions that could introduce scientific requirements that are discordant with standards in their home markets. Discordant data requirements could result in additional clinical trials and animal studies, exposing more patients to experimental drugs and increasing the use of laboratory animals.
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From page 80...
... • Discuss options and approaches that could facilitate or underlie systemic organizational efforts to develop and/or evolve harmonized standards. n  Discuss potential structures, methodologies, goals, and outcomes.
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From page 81...
... M Leufkens Chair, Dutch Medicines Evaluation Board; Member, Committee on Human Medicinal Products, European Medicines Agency Session i: principles and definitional considerations Session Objectives: • Examine key definitions and terminology: "harmonization" vs.
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From page 82...
... Series of Presentations  Conference on Harmonisation of Technical International Requirements for Registration of Pharmaceuticals for Human Use (ICH) Toshiyoshi Tominaga Professor Osaka City University Hospital Latin America James Fitzgerald Senior Advisor, Essential Medicines and Biologicals Pan American Health Organization APEC Regulatory Harmonization Steering Committee (RHSC)
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From page 83...
... Discussion with Speakers and Audience Discussion Topics/Questions • Description and characterization of existing international standards-setting bodies • Description and examination of regional harmonization efforts • Identification and discussion of particular standards that have been developed 12:30 p.m. LUNCH Session iii: areas of need for harmonized standards and barriers to progress in addressing the gaps Session Objectives: • Discuss gaps in the current structures, approaches, and interna tional standards leading to unnecessary discordance among regu latory requirements.
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From page 84...
... Food and Drug Administration Overview: Gaps from the Perspective of NGOs/ Foundations/Product Development Partnerships Vincent Ahonkhai Deputy Director, Regulatory Affairs Bill & Melinda Gates Foundation 2:00 p.m. Overview of Charge to Breakout Groups Steven Galson, Session Chair Vice President for Global Regulatory Affairs Amgen Inc.
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From page 85...
... Adjourn Day One Day Two: February 14, 2013 8:30 a.m. Welcome and Reflections from Day One Steven Galson, Workshop Co-Chair Vice President for Global Regulatory Affairs Amgen Inc.
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From page 86...
... Series of Presentations Radiation Safety Standards Cindy Flannery Senior Health Physicist U.S. Nuclear Regulatory Commission Reflections on the Experiences of the World Health Organization Lembit Rägo Coordinator for Quality and Safety of Medicines World Health Organization 9:10 a.m.
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From page 87...
... Brennan, Session Chair Senior Advisor, Global Affairs Aeras 10:05 a.m. Reaction Panel: Potential Solutions from Stakeholder Perspectives Vincent Ahonkhai Deputy Director, Regulatory Affairs Bill & Melinda Gates Foundation Raymond Chua Group Director, Health Products Regulation Group Singapore Health Sciences Authority Mary Lou Valdez Associate Commissioner for International Programs U.S.
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From page 88...
... World Health Organization Andreas Seiter, Chair of Session II Senior Health Specialist Pharmaceuticals, Health, Nutrition, and Population World Bank Steven Galson, Chair of Session III Vice President for Global Regulatory Affairs Amgen Inc.
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From page 89...
... Food and Drug Administration Hans-Georg Eichler Senior Medical Officer European Medicines Agency Alan Morrison Vice President for International Regulatory Affairs and Safety Amgen Inc.
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Key Terms

  • regulatory harmonization
  • global regulatory
  • regulatory affairs
  • session chair
  • harmonized standards

  • senior advisor
  • medical product
  • discuss potential
  • senior health
  • essential medicines

  • steven galson
  • regulatory standards
  • health specialist
  • global health
  • global affairs

  • harmonized regulations
  • critical path
  • current organized
  • james fitzgerald
  • hans hogerzeil

  • andreas seiter
  • organized efforts
  • path institute
  • potential structures
  • systemic organizational

  • organizational efforts
  • biomedical products
  • senior fellow
  • apec regulatory
  • considerations session


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