Help Us Do Our Job Better

Evaluations received by Monday, 12 November from attendees will be entered for a chance to win an iPad and the RAPS Fundamentals e-Book Series. You will receive one entry per evaluation submitted (including the General Evaluation, Workshop Evaluations and Session Evaluations). Your feedback is critical to the improvement of our programs and to our efforts to offer you the solutions you need to face challenges in regulatory.

General Evaluation

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Workshop and Session Evaluations

Friday | Saturday | Sunday | Monday | Tuesday

Friday, 26 October

9:00 am–5:00 pm

• CMC Workshop: Key Implications for Regulatory Professionals & Their Role as Business Partners (day 1)
• US Regulatory Essentials, Pharmaceuticals & Biologics
• EU Regulatory Essentials, Medical Devices & IVDs

Saturday, 27 October

8:30 am–5:00 pm

• CMC Workshop: Key Implications for Regulatory Professionals & Their Role as Business Partners (day 2)
• US Regulatory Essentials, Medical Devices & IVDs
• EU Regulatory Essentials, Pharmaceuticals & Biologics
• Combination Product Regulation for the US Market
• Medical Devices in Latin America: Engaging Regulatory Challenges
• Regulatory Managers Boot Camp
• Strategic Development of Biosimilars

Sunday, 28 October

8:00 am–9:30 am

• Opening Keynote and Awards Presentation

10:30 am– 12:00 pm

• Biosimilars Update
• Global Quality Systems Compliance: Pharmaceuticals
• Mobile Health: Use and Regulation of Social Media, Mobile Apps, and Software
• Health-Related Foods: Claims, Marketing, Labeling and Expectations
• Regulatory Cooperation Among AHWP, APEC and WHO
• Medical Device/IVD Advertising and Promotion in the EU
• Update OTC with Special Conditions
• Regulatory Strategy: Matching Regulatory Strategy to Business Objectives

12:15– 1:15 pm 

• Situation Room: Ethics-How Do You Deal With Ethics and People Who Don't Want to Follow The Rules?

1:15– 2:45 pm

• USP and European Pharmacopoeia Monographs
• Recalls and Public Access to Safety Information
• From Start to Submission
• Food Safety Modernization Act Implementation
• International Medical Device Regulators Forum (IMDRF): Overview
• Approval Trends and the Effect on the Pharmaceutical Industry
• Patient Medication Information (PMI): A New Global Paradigm
• Regulatory Strategy: Talent Management

3:15–4:45 pm

• Evolving Requirements for Clinical Trials in Asia
• Don't Be Haunted By Your Words: How to Avoid Mistakes that Will Destroy Your Credibility
• Electronic Standardization
• International Medical Device Regulators Forum (IMDRF): Impact on Industry
• Practical Considerations When Registering Devices in Peru and Mexico
• USP Monograph Modernization
• Unresolved Issues in Emerging Media
• Regulatory Strategy: Metrics for Regulatory Activities

Monday, 29 October

8:00–9:30 am

• Antibody-Drug Conjugates
• Clinical Evaluation of Medical Devices
• Protecting Patient Personal Health
• Global Regulatory Environment for Foods with Dietetic and Medical Purposes: Asia
• Revisions to the 510(k) Process
• Regulatory Approaches to 3rd Edition IEC 60601-1 for US, EU and Brazil
• Challenges in Pediatric Drug Development
• Speeding Products to Patients

9:45–10:30 am

• Exhibit Hall Sponsored Session: Regulatory Strategies for Medical Device Companies to Succeed in Asia

10:30 am–12:00 pm

• Biomarkers and Targeted Therapies
• Do Device Trials Require Reinventing?
• A Global FDA Compliance Update
• Global Regulatory Environment for Foods with Dietetic and Medical Purposes: Americas and EU
• Medical Device/IVD Advertising and Promotion in the US
• SFDA Session
• Developing Regulatory Strategies for International and Changing Markets: Pharmaceuticals
• Prescription Drug User Fee Act (PDUFA) V

12:15–1:15 pm

• Situation Room: How Sponsors Can Improve Quality of FDA Submissions (Best Practices for Assuring Quality of Submissions; Using Good Grammar, Presentation Quality)
• Situation Room: How to Establish Credibility with FDA/Other Regulatory Bodies

1:15–2:45 pm

• Compliance Issues in Biologics
• Conducting Pediatric Clinical Trials
• Good Manufacturing Practices in Brazil: Overview and Latest Trends
• Regulatory Environment Around Companion Diagnostics
• EU Medical Devices Directive
• Pharmaceuticals in Latin America
• Developing Regulatory Strategies for International and Changing Markets: Medical Devices
• Generic Drug User Fees

3:15–4:45 pm

• New Frontiers in Vaccines
• Clinical Evaluation of IVDs in the US and EU
• Auditing in the International Community
• Japan Regulator Briefing - Medical Device Regulatory Requirements and Updates
• Generics
• Comparative Effectiveness Research Trends in the US: Perspectives from Multiple Stakeholders
• Regulatory Strategy: Communicating Value of Regulatory Throughout the Organization
• Medical Device User Fee and Modernization Act (MDUFMA)

5:00–6:00 pm

• Agency Plenary: Case for Quality Initiative

Tuesday, 30 October

8:00–9:30 am

• Cell and Gene Therapy
• Utilization of Adaptive Clinical Trials
• Promoting Device Quality in a Global Marketplace
• Unique Device Identification
• How to Protect Your Device and Company Against Counterfeit
• Developing a Successful Regulatory Strategy
• Regulatory Leader Panel: Becoming Strategic Business Partners in an Organization

10:00 am–12:00 pm

• Closing Plenary