Track 9: Regulatory
This track is composed of 23 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
- Preparing for a US FDA Advisory Committee Meeting
- Precedent: A Driver of Regulatory Strategy
- Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
- FDA Advisory Committee Purpose and Non-inferiority Case Study: Rivaroxaban
- From API via eCTD to ADR: Cross-Functional Data Sharing via Regulatory Information Excellence
- Back to the Future: Combination Products in the 21st Century
Included Topic Areas in Regulatory
DIA 2018’s Program and full list of sessions will be available in January. Meanwhile, see what topics and priorities we are designing content for.
- Implications for global development strategy
- Expedited registration pathways, novel development strategies and novel approvals
- Real-world data/real world evidence, biomarkers, clinical outcome assessments, including PROs
- Common Protocol Template
- Global harmonization/convergence impact to drug development
- Expansion of ICH membership as well as other global harmonization activities (e.g., APEC-RHSC, IMDRF)
- Effect of emerging regulations on global development (e.g., IDMP, import/export, CMC)
- Effect of emerging regulations on global registration strategies
- Regulatory considerations for special populations or situations
- Pediatrics, orphan drugs, ultra-rare diseases, etc.
- Recent legislation to understand impact on global development plans with regard to differences in EU/US approach
- Innovation and technologic advancements to improve the practice of regulatory affairs
- Enhancing regulatory intelligence (AI), improving decision-making in regulatory science
- Combination Products
- Complex drug development
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.