More than 70 sessions in eight specialized tracks bring you the specialized regulatory news, updates and analysis that you need. Featuring speakers from industry, government and academia, you get access to the profession’s leading experts ready to share the latest information, across product lines and for all levels. View the complete list of confirmed speakers.
Educational Tracks
Biologics/Biotechnology
- EMEA Executive Staff Briefing
- FDA CBER Executive Staff Briefing
- Follow-on Biologics (Biosimilars)
- Understanding FDA Regulation of Human Tissue Products
- Understanding the EU Regulations on Human Tissue Products
- US and EU Regulatory Oversight of Vaccines
Business Strategy
- Emerging Opportunities (/and Challenges) in Product Lifecycle Management in – Asia and, Europe
- Emerging Opportunities/ (and Challenges) in Product Lifecycle Management in the– US
- The Importance of Global Regulatory Strategy
- Risk Communication
- Trends in FDA Enforcement
Clinical Trials
- Adaptive Clinical Trial Design–Mechanics
- Adaptive Clinical Trial Design–Case Studies
- Clinical Trials Transformation Initiative, (CTTI)
- Emerging Safety Issues in Clinical Trials
- Exploratory Clinical Trials
- Patient Reported/Health Outcome Studies
- Strategic Global Allocation of Trials: Therapeutic Areas and Major Conditions
- A Truly Global Product Development Plan
Combination Products
- Combination Product Review at EMEA: Latest Initiatives
- Combination Product Review at FDA: Latest Initiatives Combination Products: Regulatory Challenges and Latest FDA Initiatives
- Drug-Biologics Combination Product: A Regulatory Perspective
- Drug–Device Combination Products: A Regulatory Perspective
- FDA Advertising and Promotion Requirements for Combination Products
- GMP and Adverse Event Reporting
- Navigating the Japanese and the Chinese Regulations With a Combination Drug-Device Product
International Regulatory Issues
- Environmental Regulations: and the Impact on Device, Drug and Biologics Development
- Global Harmonization: –Fact or Fiction?
- Japan Regulatory and Reimbursement Update
- Pharmaceutical Anti-Counterfeiting Strategies
- Regulatory Hot Topics Overview:– Asia
- Regulatory Hot Topics Overview: –Canada and Latin America
Medical Devices
- Advertising and Promotion of Medical Devices
- Clinical Registry and Reimbursement Strategy
- FDA CDRH Executive Staff Briefing
- GHTF Overview and Status
- IVD Multivariate Index Assays (IVDMIAs)
- National Regulatory Requirements for EU: Beyond the CE Mark
- Postmarket Clinical Registries
- Postmarket Surveillance for Medical Devices
- Pre-IDE Process: Optimizing Your Results
- Product Testing and the China Regulatory Environment
- Re-use of Single Use Devices (SUDs)
- Risk Management: interpretation of ISO 14971:2007
Pharmaceuticals
- CDER Executive Staff Briefing
- CHMP/EMEA Executive Staff Briefing
- Emerging Market and Regulatory Agencies: Asia
- Emerging Market and Regulatory Agencies: Latin America
- Environmental Risk Assessment
- Pediatric Development in the US
- Postmarket Surveillance of Pharmaceuticals
- Quality by Design ICH Q8, Q9 and Q10
- Risk Assessment of Pharmaceuticals in the Environment (PIE)
- Rx to OTC Switch
- Seeking Balance: Regulation, Innovation and Cost-Containment of Orphan Biopharmaceuticals
- Topical Products, Complexes and Local Acting Products
- Update on Defining Cardiac Safety Using QTc
Professional Issues
- Communication Practices with Worldwide Regulatory Agencies: Non-ICH Regions and Japan
- Communication Practices with Worldwide Regulatory Agencies: North America and Europe
- How Did I Get Here? Career Development Panel
- Internships/Mentoring: Best Practices for Developing New Regulatory Professionals
- Masters of Our Domain: Furthering the Regulatory Education of Busy Regulatory Professionals and the Development of a Top Notch Regulatory Staff
- Regulatory Affairs Career Options: Finding the One That’s Right for You
CONFERENCE PROGRAM COMMITTEE
CHAIRMAN
David Jefferys, MD, Vice President, Global Regulatory Affairs, Eisai
Corporation Europe; RAPS Board of Directors, President-elect
COMMITTEE
Patricia Anderson, RAC, Vice President, Regulatory Services,
CanReg Inc.
Nancy Coulson, Worldwide Director of RA, Cordis Corporation
Hal Hopkins, RAC, Associate Director Quality Control, Abbott
Laboratories
Hutch Humphreys, RAC, Senior RA Associate, Amylin Pharmaceuticals
Anthony Humphreys, Head of Sector, RA and Organisational
Support, European Medical Enforcement Agency (EMEA)
Joel Kent, RAC, Manager, Quality and Regulatory Affairs, GE
HealthCare
Murray Lumpkin, Deputy Commissioner International & Special
Programs, US Food and Drug Administration
Meredith Manning, JD, Attorney, Hogan & Hartson LLP
Kyoichi Tadano, PhD, Director, International Affairs Division,
Pharmaceuticals and Medical Devices Agency (PMDA)
COMMITTEE LIAISONS
Gary Baker, RAC, Regulatory Affairs Specialist, Biomet Inc. (Ethics Committee Liaison)
William Morton, RAC, Founder and President, Medical Device
Consultants Inc., RAPS Board of Directors