CMC Regulatory Compliance of Biopharmaceuticals 2014

  • 15-16 Jul 2014
  • AAPS, North York, Canada

Description

CMC Regulatory Compliance of Biopharmaceuticals 2014 is a course that covers topics such as:

  • How to Develop an Effective Corporate CMC Risk-Managed Regulatory Compliance Strategy for Biologics
    • Five (5) essential elements of an effective CMC strategy
    • The two major forces that shape the CMC regulatory compliance strategy of biologics
    • Necessity of a clinical phase-appropriate CMC regulatory compliance strategy
    • Impact of the strategic ICH guidances (Q8/Q9/Q10) on biologics
  • CMC Regulatory Challenges for Biologics are Different
    • Comparison of the regulatory authorities (FDA, EMA/NCA) and regulatory review pathways (IND/IMPD, NDA/BLA, MAA centralized procedure) for biologics
    • Understanding the terminology landscape: biologic, specified biologic, biopharmaceutical, biosimilar
    • Biologics are not chemical drugs - four (4) unique CMC regulatory compliance challenges presented by biologics
    • The five (5) CMC regulatory compliance differences between the two U.S. pharmaceutical laws for biologics
  • Challenge of Managing Manufacturing Process Changes and Demonstrating Biologic Product Comparability - Not an Easy Task
    • Demonstrating biologic product comparability - surprises happen!
    • Risk-based, sequential, clinical phase-appropriate comparability studies
    • Extreme CMC comparability - biosimilars - limitations of CMC biosimilarity
    • Difference between a FDA comparability study and a FDA comparability protocol
  • Applying the CMC Regulatory Compliance Risk-Managed Strategy to Control of Biologic Manufacturing Processes
    • Need for clonality
    • Critical importance of biologic starting materials - four (4) myths about cell banks
    • Formulation and container-closure challenges for biologics - impact of components on biologic (e.g., aggregation) and impact of biologic on components (e.g., glass flaking)
    • Genetic stability, small-scale studies and clinical phase-appropriate control of the biologic manufacturing process
    • Illustration of Quality-by-Design (QTPP, CQAs, CPPs, risk-ranking) in selecting the control system for a biologic process

CMC Regulatory Compliance of Biopharmaceuticals 2014 brings together Directors, Senior Management, Regulatory Affairs, Managers/ Supervisors QA/QC, Process Development personnel and Manufacturing interested or involved in the manufacture and control and CMC regulatory issues of biopharmaceuticals.

Past Events

Important

Please, check "CMC Regulatory Compliance of Biopharmaceuticals" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Pharma
Technology: Biotechnology

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