Track 9: Regulatory
This track is composed of sessions addressing global laws, regulations, guidelines, and guidances that govern prescription biopharmaceutical and device product development, approval, and maintenance. Representatives from FDA, EMA, PMDA, MHRA, BfArM, and ICMRA authorities, and other regulatory experts will provide global updates, insights, and discussion on current issues, opportunities, and challenges through interactive forums. Themes include, Global Regulatory Changes and Impact on Global Development Strategies, Global Harmonization/Convergence and Impact on Drug Development, Advances and Innovations to Improve the Practice of Regulatory Affairs, and Regulatory Hot Topics.
Sessions in Regulatory
Sunday, June 23 | Short Courses
- Basics of European Medical Device Regulation
- Preparing for a US FDA Advisory Committee Meeting
- European Regulatory Meetings: How Best to Prepare and Perform
- Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
Monday, June 24
- Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs
- International Regulatory Convergence
- Hype Versus Reality: Artificial Intelligence and Real World Evidence
- Communications with Regulators Beyond Formal Meetings
- Update from Health Canada: The Health Protection Branch
- Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What do Industry and Patients Need to Know?
- Drug Development Tools in a Digital Era
- National Medical Products Administration (NMPA) Town Hall
- Strategic Priorities of the International Coalition of Medicines Regulatory Authorities in an Increasingly Globalized Industry ICMRA Update
Tuesday, June 25
- Identifying the Reference Listed Drug for ANDA Submission, Overview of FDA’s Orange Book, and Exclusivities for NDAs and ANDAs
- Facilitating Access: Patient Perspectives on a Streamlined Development Approach for Treatments for Severely-Debilitating or Life-Threatening Diseases
- Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504?
- The Future of Combination Products in the EU
- Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges
- PMDA Town Hall
- Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings from the RCT-DUPLICATE Project
- Harmonizing Regulatory Science Through the International Council for Harmonization (ICH)
- Current Status of FDA Framework for the Evaluation of Real World Evidence
- Driving Complex Generics to Approval: What Are the Keys to Success
- Update From the US FDA on Progress and Topics of Current Interest in US Biosimilar Policy, Regulation, and Outreach/Education
- Prescription Drug Labeling: New Guidances from the US FDA
- Informing Development and Authorizations Using Real World Evidence/Artificial Intelligence
Wednesday, June 26
- Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision-Making: When, Where, and Why
- Medical Devices: EU Medical Device Regulation, PMDA Updates, and US MDUFA IV – Where Are We Now?
- Hot Topics in Quality and Regulatory Affairs for Combination Products
- Digital Technology Advances Labeling Management and Patient Access
- The Evolving Gene Therapy Regulatory Framework: A Brave New World
- When is Real World Evidence Ready for Prime Time?
- Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where Are We and What Have We Learned?
- Global Rare Disease Town Hall
- User-Fee Programs Myth Busting: General Financial Principles Explained
- Convergence of the Regulatory Pathways for Advanced Therapy Medicinal Products
- Transparency, Expanded Access Navigator, Right to Try: Helping Patients Get Access to Investigational Medicines?
- Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints
- Real World Evidence and Artificial Intelligence to Inform Post-Authorization Studies
- Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Experience, Analysis, and Reflections from EMA, FDA, and Industry
Thursday, June 27
View one of our video interviews from DIA 2018 with Demetra Macheras, Director, Regulatory Affairs, Abbvie, Inc., as she explains the regulatory challenges in the development and lifecycle management of drug-device combination products.
Who is This Track Designed For?
Professionals involved in: Regulatory affairs and strategy, regulatory operations, regulatory information management, regulatory agencies, government affairs, legal affairs and compliance, policy and intelligence, clinical research and operations, PV, HTA, project management, and service providers developing tools and resources for use by sponsors and CROs.