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CMC/Regulatory Affairs for Nucleic Acids

CMC/Regulatory Affairs for Nucleic Acids

25 – 27 March 2026

Price available after dates are announced

TRAINING TIMES

  • 13:00 - 18:00Vienna
  • 12:00 - 17:00London
  • 08:00 - 13:00New York
  • 05:00 - 10:00Los Angeles
Online Training

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 INCLUDE

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.



WHO IS THIS TRAINING FOR?

Designed for professionals who want to enhance their expertise and advance their careers

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

Dr. Len Pattenden

Dr. Len Pattenden

CMC Expert and Independent Consultant 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 been a company founder, COO and GMP site head/license holder, overseeing biopharma development and manufacture as well as outsourced CDMO activities. 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. Len’s regulatory and licensing experience covers the MHRA, EMA and FDA. Len works as a CMC consultant for small and large pharmaceutical companies. We are live on webchat!

Learn More →

Video Invitation

Watch the video invitation from the trainer.

Sneak peek

Sneak Peek

Take a sneak peek at the trainer's presentation.

View PDF →