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Program

Choose from more than 60 educational sessions, led by experts and enriched by the experience of your fellow attendees. Vibrant, interactive sessions—not droning monologues.

Whether you need the diversity of multiple tracks or the in-depth knowledge from regulatory workshops, 2012 RAPS provides the information and expertise to elevate your contribution to your organization and the profession.

Program at a Glance

View the Workshop and Educational Session titles below, download the Program at a Glance in PDF, or view the Schedule at a Glance. The expanded Session Schedule, Agenda Builder and Mobile App will be available soon.

Friday, 26 October | Saturday, 27 October | Sunday, 28 October | Monday, 29 October | Tuesday, 30 October

Friday, 26 October—Workshops

9:00 am-5:00 pm
US Regulatory Essentials, Pharmaceuticals & Biologics
EU Regulatory Essentials, Medical Devices & IVDs
CMC Workshop: Key Implications for Regulatory Professionals & Their Role as Business Partners

Saturday, 27 October—Workshops

8:30 am-5:00 pm
US Regulatory Essentials, Medical Devices & IVDs
EU Regulatory Essentials, Pharmaceuticals & Biologics
CMC Workshop: Key Implications for Regulatory Professionals & Their Role as Business Partners
Strategic Development of Biosimilars
Regulatory Managers Boot Camp
Combination Product Regulation in the US Market
Medical Devices in Latin America: Engaging Regulatory Challenges

Sunday, 28 October—Educational Sessions

TRACK 8:00-9:30am 10:30am-12:00pm 1:15-2:45pm 3:15-4:45pm 5:00-6:00pm
Plenary Opening Keynote       Definition, Development and Application of Regulatory Science
Biologics & Biotechnology   Biosimilars Update USP and European Pharmacopoeia Monographs    
Clinical       Evolving Requirements for Clinical Trials in Asia  
Compliance   Global Quality Systems Compliance: Pharmaceuticals The Global Postmarket World Don't Be Haunted By Your Words: How to Avoid Mistakes that Will Destroy Your Credibility  
Electronic Interaction   Mobile Health: Use and Regulation of Social Media, Mobile Apps, and Software From Start to Submission Electronic Standardization  
Health-
Related Foods		   Health-Related Food: Claims, Marketing, Labeling, and Expectations Food Safety Modernization Act Implementation    
Medical Devices and In Vitro Diagnostics   Companion Diagnostics International Medical Device Regulators Forum (IMDRF ): Overview International Medical Device Regulators Forum (IMDRF): Impact on Industry  
Medical Device/IVD Advertising and Promotion in the EU Pitfalls When Registering Devices in Brazil and Mexico
Pharmaceuticals   Update: OTC with Special Conditions Patient Medication Information (PMI): A New Global Paradigm USP Monograph Modernization  
Approval Trends and the Effect on the Pharmaceutical Industry Pharmaceuticals Advertising and Promotion in the US
Regulatory Business   Regulatory Strategy: Matching Regulatory Strategy to Business Objectives Regulatory Strategy: Talent Management Regulatory Strategy: Metrics for Regulatory Activities  

Monday, 29 October—Educational Sessions

TRACK 8:00-9:30am 10:30am-12:00pm 1:15-2:45pm 3:15-4:45pm 5:00-6:00pm
Plenary         Agency Plenary
Biologics & Biotechnology Biomarkers and Targeted Therapies Antibody-Drug Conjugates Compliance Issues in Biologics New Frontiers in Vaccines  
Clinical   Debate on the Ethics of Medical Device Clinical Trials Conducting Pediatric Clinical Trials Clinical Evaluation of IVDs in the US and EU  
Compliance   FDA Regional and District Director Update Quality Systems Compliance in Brazil International Audits  
Electronic Interaction Protecting Patient Personal Health        
Health-
Related Foods		 Global Regulatory Environment for Foods with Dietetic and Medical Purposes: Asia Global Regulatory Environment for Foods with Dietetic and Medical Purposes: Americas and EU      
Medical Devices and In Vitro Diagnostics Revisions to the 510(k) Process Medical Device/IVD Advertising and Promotion in the US Asian Harmonization Working Party/Asia-Pacific Economic Cooperation – Joint Efforts Toward Free Trade Japanese Medical Device/IVD Update Session  
Global Registration Updates: Electrical Safety Standards Labeling and Postmarket Surveillance Challenges in China EU Medical Devices Directive
Pharmaceuticals Cross Communication with Health Authorities (Strategic Decision Making)   Pharmaceuticals in Latin America Comparative Effectiveness  
Challenges in Pediatric Drug Development Generics
Regulatory Business Regulatory Strategy: Communicating Value of Regulatory Throughout the Organization Developing Regulatory Strategies for International and Changing Markets: Part 1 Developing Regulatory Strategies for International and Changing Markets: Part 2 Regulatory Leader Panel: Becoming Strategic Business Partners in an Organization  
User fees   Prescription Drug User Fee Act (PDUFA) Generic Drug and Biosimilars User Fees Medical Device User Fee and Modernization Act (MDUFMA)  

Tuesday, 30 October—Educational Sessions

TRACK 8:00-9:30am 10:00am-12:00pm
Plenary   Closing Plenary
Biologics & Biotechnology Cell and Gene Therapy  
Clinical Utilization of Adaptive Clinical Trials  
Clinical Evaluation of Medical Devices  
Compliance Comparison of Emerging Compliance Trends  
Medical Devices and In Vitro Diagnostics Pitfalls When Entering New International Markets  
Unique Device Identification
Pharmaceuticals Speeding Products to Patients  
Developing a Successful Regulatory Strategy