概览

The International Council for Harmonisation (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.

谁应该参加？

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

学习目标

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

注册

International Regulatory Collaboration through ICH and Latest Developments for Regulatory Affairs

概览

谁应该参加？

学习目标

获得信息并保持参与