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Virtual

Oct 15, 2025 11:00 AM - Oct 15, 2025 12:15 PM

(US Eastern Standard Time)

International Regulatory Collaboration through ICH and Latest Developments for Regulatory Affairs

Overview

The International Council for Harmonization (ICH) was established to bring together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registrations, aiming to ensure safe, effective, and high-quality medicines. This webinar aims to provide an overview of ICH and share recent developments in ICH Guidelines including advancements in M11 for clinical trial protocols and updates to M4Q(R2) for quality documentation. The session will conclude with a Q&A segment, providing an opportunity for attendees to engage with experts from regulators and industry.

Who should attend?

  • Clinical Data/Data Managers
  • Clinical Operations and Processes
  • Contract Research and Service Support Providers
  • Document and Records Management/Specialists
  • Emerging Pharmaceutical/Biotech/Device Professionals
  • Essential Document Process and Business System Owners
  • Informatics/Bioinformatics Professionals
  • Information Technology and Support Personnel
  • Medical, Technical, and Regulatory Writers
  • Outsourcing/Clinical Outsourcing
  • Quality Assurance/Quality Control and Compliance Professionals
  • Quality Management
  • Regulatory Affairs and Operations
  • Regulatory Informatics
  • Regulatory Information Management
  • Regulatory Standards Implementation Specialists and Associates
  • Strategic Planning and Operations
  • Submissions and Global Submissions Management/Project Management
  • TMF and eTMF Management
  • Vendor Relationship Managers

    Learning objectives

    • At the conclusion of this activity, participants should be able to:

      • Describe the role and mission of ICH, including its purpose, structure, and impact to regulators and industry
      • Explain key updates and advancements in ICH Guidelines, with a focus on M11 and M4Q(R2)
      • Apply the information from experts on the practical applications and future directions of ICH initiatives

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