Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.

1. Legislative Views on Risk Management in Healthcare Products and Services Tri-Division Conference Regulations and Regulators Joseph Curtis MS, PhD March 27, 2008

2. Global Risk Management Infrastructure Healthcare Products and Services FDA 3 2007 China-US Food Safety 2007 China-US Safety of Drugs & Medical Devices 2007 IMI Joint Undertaking Australia - US Cooperative Agreement 2007 Advanced Therapy Medicinal Products & Amending Directive Post-Market Surveillance Study 2008

5. US Legislation Initiatives Healthcare Product Risk Management Legislative Approach to Managing Risks to Consumers of Medical Technology The United States continues to expand its risk management infrastructure by integrating postmarket surveillance with eHealth tools for consumer safety, and apply science-based approaches to minimizing potential risks associated with medical technology. Additional efforts have been initiated to innovate across the risk continuum and introduce advanced technology into the marketplace at reduced risk to the consumer. Efforts to harmonize regulatory practice and extend the best practice in consumer safety into markets across the global medical product supply chain will also be examined.

12. Global Clinical Trial Registry Network ICTRP CTRI CLINICAL TRIALS REGISTRY INDIA

33. International Legislation for Risk Management Global Legislative Tools for Risk Management The global international community has responded to the direction of the World Health Organization and the United States to harmonize regulatory practice and extend the best practice in consumer safety into markets across the globe. Australia China Canada European Union

41. Global Risk Management Infrastructure Healthcare Products and Services FDA 3 2007 China-US Food Safety 2007 China-US Safety of Drugs & Medical Devices 2007 IMI Joint Undertaking Australia - US Cooperative Agreement 2007 Advanced Therapy Medicinal Products & Amending Directive Post-Market Surveillance Study 2008

42. Discussion Items Joseph Curtis MS, PhD Legislative Views Risk Management in Healthcare Products ASQ Tri-Division Conference 2008 email: [email_address]