Summary
This intensive 3-day course provides a deep dive into the critical aspects of Chemistry, Manufacturing, and Controls (CMC) and Regulatory Affairs in the development of nucleic acid therapeutics. Participants will gain a thorough understanding of the quality requirements, regulatory expectations, and best practices necessary to navigate the complex landscape of nucleic acid drug development.
Learning Objectives
- Understand the regulatory frameworks governing nucleic acid therapeutics
- Develop effective CMC strategies to ensure product quality and compliance
- Implement robust quality control and assurance measures throughout the development lifecycle
- Gain insights into manufacturing processes and facilities specific to nucleic acid drugs
- Master analytical methods for characterization and stability assessment
- Navigate post-approval changes and lifecycle management effectively
- Mitigate risks and maintain compliance with regulatory requirements
Key Topics
- Regulatory Frameworks and Guidelines
- CMC Strategies for Nucleic Acid Therapeutics
- Quality Control and Assurance
- Manufacturing Processes and Facilities
- Analytical Methods and Characterization
- Stability Studies and Comparability Assessments
- Post-Approval Changes and Lifecycle Management
- Risk Management and Compliance
Who should attend?
- Regulatory Affairs Specialists
- CMC Professionals
- Quality Control/Assurance Personnel
- Manufacturing Engineers and Managers
- Research and Development Scientists
- Project Managers and Executives
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Digital and LinkedIn certificates
Trainers
Len has over 30 years of experience in both industry and academia. He is a member of a regulatory advisory group for ATMPs. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. His regulatory and licensing experience covers the MHRA, EMA and FDA.
CMC/Regulatory Affairs for Nucleic Acids
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