CMC/Regulatory Affairs for Nucleic Acids
DNA, RNA, and PNA Active Pharmaceutical Ingredients, Drug Substances, and Drug Products
25 – 27 March 2026
1850 €
TRAINING TIMES
13:00 - 18:00 Vienna
12:00 - 17:00 London
08:00 - 13:00 New York
05:00 - 10:00 Los Angeles
WHY SHOULD YOU ATTEND?
Develop effective CMC strategies
to ensure nucleic acid product quality and compliance.
Master analytical methods
for product characterization and stability assessment.
Gain insights into manufacturing
processes and facilities specific to nucleic acid drugs.
Navigate post-approval changes
and lifecycle management effectively.
OUR ONLINE TRAINING EXPERIENCE INCLUDES
Three days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
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 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
WHO IS THIS TRAINING FOR?
Regulatory Affairs Specialists
CMC Professionals
QC/QA Personnel
Manufacturing Engineers
Manufacturing Managers
R&D Scientists
Project Managers
Project Executives
KEY TOPICS
Regulatory Frameworks and Guidelines
Analytical Methods and Characterization
Post-Approval Changes and Lifecycle Management
Quality Control and Assurance
CMC Strategies for Nucleic Acid Therapeutics
Stability Studies and Comparability Assessments
Risk Management and Compliance
Manufacturing Processes
TRAINER
PAST PARTICIPANTS
CMC/Regulatory Affairs for Nucleic Acids: DNA, RNA, and PNA Active Pharmaceutical Ingredients, Drug Substances, and Drug Products
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
