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CMC Workshop: Translating Science Into Successful Regulatory Submissions

Source: DIA

Sustaining Clinical Trial Disclosure
Discuss Challenging Topics Facing the Pharmaceutical and Biopharmaceutical Communities from Development, Implementation, and Regulatory Submissions Perspectives.

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Event Brochure: CMC Workshop: Translating Science Into Successful Regulatory Submissions

Date(s) And Time(s):
Feb 7 2011 7:30AM - Feb 9 2011 12:00PM

Location:
Washington Hilton Hotel
1919 Connecticut Avenue, NW
Washington, DC 20009

Interest Area(s):
CMC, Regulatory Affairs, Project Management, Strategic Planning

Overview:
Co-sponsored by the American Association of Pharmaceutical Scientists.

Discuss Challenging Topics Facing the Pharmaceutical and Biopharmaceutical Communities from Development, Implementation, and Regulatory Submissions Perspectives.

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 postapproval changes.

Plenary Sessions

  • 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
  • Postapproval Changes in a Global Regulatory Environment and Requirements

Breakout Sessions

  • 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)
  • Discussing the 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 Postapproval Change Protocols
  • The New EU Variations Regulation: 1 Year Later
  • Post-Notice of Compliance (NOC) Changes: 1 Year Later

This program has been developed by the CMC Working Group of the DIA Regulatory Affairs Special Interest Area Community.

Learning Objectives:
At the conclusion of this workshop, participants should be able to:

  • Discuss the current CMC hot topics for chemical and biological products
  • Describe how to manage technical challenges and regulatory requirements within CMC cross-functional teams throughout product lifecycle
  • Explain how to implement Quality by Design concepts (ICH Q8, 9, 10, and 11)
  • Identify how to overcome issues in setting DS/DP specifications and evaluate genotox impurities requirements
  • Outline how to plan global stability studies
  • Discuss how to develop CMC documentation for global submissions
  • Explain the most recent trends for post-approval changes
  • Describe how to organize for inspections readiness

Target Audience:
Professionals involved in:

  • CMC regulatory affairs and technical functions
  • API development and manufacturing
  • Formulation development and manufacturing
  • Analytical development
  • Quality assurance/control
  • CMC life cycle management
  • CMC project management
  • Biotechnology

Click Here To Download:
Event Brochure: CMC Workshop: Translating Science Into Successful Regulatory Submissions