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Help Us Do Our Job Better » Please share your feedback on 2011 RAPS on the RAPS General Evaluation Session Evaluations Saturday \| Sunday \| Monday \| Tuesday \| Wednesday Saturday, 22 October The Essentials: US Regulatory Affairs - Medical Devices and IVDs (Part 1) The Essentials: EU Regulatory Affairs - Drugs and Biologics (Part 1) Regulatory Strategy Forum for Pharmaceuticals (Part 1) [ back to top ] Sunday, 23 October The Essentials: US Regulatory Affairs - Drugs and Biologics (Part 2) The Essentials: EU Regulatory Affairs - Medical Devices and IVDs (Part 2) Regulatory Strategy Forum for Pharmaceuticals (Part 2) Combination Product Regulation in the US Market Regulatory Managers Boot Camp Over the Counter Drugs: Classification, Approval and Compliance, a Practical Review Generics in the US: A Regulatory Primer on Filings and Recent Actions [ back to top ] Monday, 24 October 8:30–10:00 am Opening Keynote 10:30 am–12:00 pm Recent Regulatory Developments in Biologics/Biotechnology GMP: Supplier Management and Controls Software as a Medical Device and Home Use of Medical Devices Global Trends in IVD Regulation FDA Reviewer Panel Helping Patients Understand Medication Risks: How Can We Do Better? Recent Trends in Global Generic Filings Developing a Consulting Business 12:15–1:15 pm Situation Room: Your Mother Was Right, Always Tell the Truth–A Discussion of Ethics in Regulatory 1:30–3:00 pm Drug Delivery Systems for Biologic Therapeutics–Answers to Regulatory Questions Compliance Ethics: Understanding What to Do When Health Information Technology: What Impact Does It Have on Regulatory? EU Medical Device Recast Japan Regulator Briefing–Medical Device Regulatory Requirements and Updates Biomarker Qualification: A Journey from Inception to Application Innovative Pathways to OTC Approval Impact of Regulatory Milestones on Business Performance 3:30–5:00 pm Addressing Human Factors Combination Product Clinical Trials Conducting Clinical Trials Outside the US and EU Food Safety Regulation and Impact of Legislation Global Markets–Focus on Asia Emerging Device/IVD Oversight of Lab Developed Tests EMA Update Medication Errors and the Art of Naming Drugs The Role of Regulatory in Startup Small Venture Companies and Large Publically Traded Companies [ back to top ] Tuesday, 25 October 7:30–8:15 am Sponsored Session: Software to Ensure Quality and Compliance 8:30–10:00 am USP Strategies and Initiatives in Biologics and Biotechnology Safety in Clinical Trials GMP: Auditing in Drugs and Biologics GMP: Medical Device Quality Systems Social Media IVDs–Personalized Medicine/Companion Diagnostics Update of China Medical Device Supervision, Regulation and Technical Evaluation CDER Office of Pharmaceutical Science Update 10:30 am–12:00 pm Case Studies (A-mAb and Vaccine) and the QbD Pilot Simultaneous Review Clinical Trial Data for Medical Devices and IVDs Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails Foods and Global Borderline Issues with Drugs, Cosmetics, Botanicals and Food Supplements Global Markets–Focus on Device/IVD Regulation in Taiwan Oncology Drugs and Development Challenges in the Evolving Regulatory Landscape Regulatory Advertising and Promotion Review in a Time of Uncertainty The Business of Pharmacogenomics and Individualized Medicine 12:15–1:15 pm Situation Room: Do’s and Don’ts when Dealing with the FDA Situation Room: The Matrix: Managing Up and Across 12:45–1:30 pm Sponsored Session: e-Architec, An Outsourced e-Submission Service That Evolves with the Client’s Needs 1:30–3:00 pm Developments with Cellular Therapies and FDA Licensure Most Common Mistakes Sponsors Make in Pharmaceutical Clinical Trial Development and Regulatory Submission Writing Compliance with GCP The Future Regulation of Probiotics 510(k) Reform Part 1 Health Canada Medical Devices Bureau Briefing Regulatory Strategy in Pediatric Drug Development Measuring Performance of Regulatory Function and the Professional 3:30–5:00 pm Journey in the Development of Biologics Through End-of-Phase 3 FDA Inspections of Clinical Trials Postmarket Surveillance: A Global Perspective MDUFMA Reauthorization Global Markets–Focus on Middle East/Africa REMS and Risk Management Supply Chain Integrity and Counterfeiting Emerging Issues in Regulatory Intelligence [ back to top ] Wednesday, 26 October 8:30–10:00 am Conducting Clinical Trials in Biologics Outside the US and EU FDA Process Validation Guidance–The Lifecycle Approach to Validation eCTD Compliance and Regulatory Review of Clinical Study Reports Global Regulatory Environment for Foods with Dietetic and Medical Purposes Medical Devices: Case Presentations and Analysis Speeding Access to Therapeutic Goods Regulatory Affairs: Partnership and Interaction with Business Colleagues 10:30 am–12:00 pm Horizons Session [ back to top ]	Follow Us: » View Session Schedule Download the Program at a Glance Program Addendum

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