DIA, in cooperation with the American Association of Pharmaceutical Scientists (AAPS), will host a CMC Workshop: Translating Science into Successful Regulatory Submissions from February 7-9 in Washington, DC.
This three-day workshop will explore all of the challenging topics facing the pharmaceutical and biopharmaceutical communities from development, implementation, and regulatory perspectives. Plenary and breakout sessions include:
- Science and Risk-based Approach for Drug Development and Manufacturing: Drug Product and Drug Substance (ICH Q8, 9, 10, and 11)
- Setting Drug Substance/Drug Product Specifications
- Stability-by-Design: Alternatives to Traditional Stability Studies
- Post-approval Changes in a Global Regulatory Environment and Requirements
- Selection of Starting Materials and Discussion in Dossiers (Chemical Products)
- Selection of Source Materials and Discussion in Dossiers (Biological Products)
- Batch Release in a Real-time Release Environment
- Genotox Impurities: US versus EU
- Managing Stability Studies Globally
- Pharmacopoeia Harmonization and Its Impact on Pharmaceutical Quality
- Challenges and Trends when Preparing CMC Submissions for Clinical Trials (Chemical Products)
- ASEAN CTD
- Inspections by National Regulatory Authorities: Differences in Regional Approaches
- CMC Submissions to Support Clinical Trials (Biological Products)
- Combination Products: Global Challenges and Opportunities
- Raw Material, Excipient, API Suppliers’ Auditing and EU QP Responsibility
- CMC Post-approval Change Protocols
- New EU Variations Regulation
- Post-Notice of Compliance (NOC) Changes
“This CMC workshop offers both plenary and breakout sessions, featuring cross-functional discussions on science and risk-based approaches to drug development and manufacturing, drug substance and drug product specifications, genotox impurities, global stability studies, and pos-tapproval changes,” says Program Chairperson Yasmin de Faria Krim, PharmD, MScRA, Global CMC Regulatory Affairs Manager, Johnson & Johnson, Belgium.
ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.