Who’s coming to 2011 RAPS: The Regulatory Convergence?

The best minds in the world.

Agency/Organization	Track(s)	Session Title(s)
Council of Better Business Bureaus New York, NY, USA	Health-Related Foods	Foods and Global Borderline Issues with Drugs, Cosmetics, Botanicals and Food Supplements
European Commission Brussels, Belgium	Medical Devices and In Vitro Diagnostics	EU Medical Device Recast
European Medicines Agency London, UK	Workshop Biologics/Biotechnology Pharmaceuticals Regulatory Business	The Essentials: EU Regulatory Affairs - Drugs and Biologics (Part 1) Case Studies (A–mAb and Vaccine) and the QbD Pilot Simultaneous Review Recent Regulatory Developments in Biologics/Biotechnology Developments with Cellular Therapies and FDA Licensure EMA Update Oncology Drugs and Development Challenges in the Evolving Regulatory Landscape Impact of Regulatory Milestones on Business Performance
Federal Commission for the Protection against Sanitary Risk México, D.F.	Compliance Medical Devices and In Vitro Diagnostics	Postmarket Surveillance: A Global Perspective
Food Safety and Standards Authority of India Mysore, Karnataka, India	Health-Related Foods	Global Regulatory Environment for Foods with Dietetic and Medical Purposes
Food Standards Australia New Zealand Canberra, Australia	Health-Related Foods	Global Regulatory Environment for Foods with Dietetic and Medical Purposes
Health Canada Ottawa, Ontario, Canada	Compliance Health-Related Foods Medical Devices and In Vitro Diagnostics Pharmaceuticals	Postmarket Surveillance: A Global Perspective Foods and Global Borderline Issues with Drugs, Cosmetics, Botanicals and Food Supplements The Future Regulation of Probiotics Health Canada Medical Devices Bureau Briefing Oncology Drugs and Development Challenges in the Evolving Regulatory Landscape
Health Sciences Authority Singapore	Medical Devices and In Vitro Diagnostics	Global Trends in IVD Regulation Global Markets–Focus on Asia Emerging Device/IVD
Korea Food and Drug Administration Seoul, South Korea	Clinical	Conducting Clinical Trials Outside of US and EU
Ministry of Health, Labour and Welfare Tokyo, Japan	Medical Devices and In Vitro Diagnostics	Japan Regulator Briefing–Medical Device Regulatory Requirements and Updates
Ministry of Health, Welfare and Sport The Hague, The Netherlands	Clinical Compliance	Clinical Trial Data for Medical Devices and IVDs Postmarket Surveillance: A Global Perspective
Pharmaceuticals and Medical Devices Agency Tokyo, Japan	Medical Devices and In Vitro Diagnostics	Japan Regulator Briefing–Medical Device Regulatory Requirements and Updates
Saudi Food & Drug Authority Riyadh, Saudi Arabia	Medical Devices and In Vitro Diagnostics	Global Markets–Focus on Middle East/Africa
State Food and Drug Administration Beijing, China	Medical Devices and In Vitro Diagnostics	Update of China Medical Device Supervision, Regulation and Technical Evaluation
Taiwan FDA Taipei City, Taiwan	Medical Devices and In Vitro Diagnostics	Global Markets–Focus on Device/IVD Regulation in Taiwan
US Food and Drug Administration, Center for Biologics Evaluation & Research Rockville, MD, USA	Biologics/Biotechnology	Developments with Cellular Therapies and FDA Licensure
US Food and Drug Administration, Center for Devices and Radiological Health Silver Spring, MD, USA	Clinical Electronic Intervention Medical Devices and In Vitro Regulatory Business	Clinical Trial Data for Medical Devices and IVDs Addressing Human Factors Combination Product Clinical Trials Software as a Medical Device and Home Use of Medical Devices 510(k) Reform MDUFMA Reauthorization FDA Reviewer Panel Impact of Regulatory Milestones on Business Performance
US Food and Drug Administration, Center for Drug Evaluation and Research Bethesda, MD, USA Silver Spring, MD, USA	Biologics/Biotechnology Clinical Compliance Electronic Intervention Pharmaceuticals Workshop	Case Studies ( A–mAb and Vaccine) and the QbD Pilot Simultaneous Review Recent Regulatory Developments in Biologics/Biotechnology USP Strategies and Initiatives in Biologics and Biotechnology FDA Process Validation Guidance–The Lifecycle Approach to Validation eCTD Compliance and Regulatory Review of Clinical Study Reports GMP: Auditing in Drugs and Biologics Social Media Biomarker Qualification: A Journey from Inception to Application Regulatory Strategy in Pediatric Drug Development Medication Errors and the Art of Naming Drugs Oncology Drugs and Development Challenges in the Evolving Regulatory Landscape CDER Office of Pharmaceutical Science Update Over the Counter Drugs: Classification, Approval and Compliance, a Practical Review Generics in the US: A Regulatory Primer on Filings and Recent Actions
US Food and Drug Administration, Center for Food Safety and Applied Nutrition College Park, MD, USA	Health-Related Foods	The Future Regulation of Probiotics Foods and Global Borderline Issues with Drugs, Cosmetics, Botanicals and Food Supplements
US Food and Drug Administration, Office of the Commissioner Silver Spring, MD, USA	Workshop	Combination Product Regulation in the US Market

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