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.
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.