CMC Regulatory Compliance for ATMPs
CMC Regulatory Compliance for ATMPs

Course Description

This 3-day CMC regulatory compliance training is designed to keep you up to date on emerging ATMP topics. You will learn how to develop good CMC-compliant regulatory practices and avoid market-approval delays. This course is suitable for all those involved in CMC development and implementation for ATMPs.
  • Operational Excellence and alignment of business and CMC drivers
  • Important and emerging CMC regulatory issues – problems and challenges
  • CMC regulatory compliance for ATMPs – EMA & FDA
  • Quality Risk Management and Quality by Design (QbD) principles for ATMPs
  • Change management for ATMPs; FMEA de-risking, tech transfer and CMC activities
  • Non-GMP materials, systems and control – making compliance and phase-appropriate acceptance
  • Analytical, storage, stability, comparability and retention for ATMPs
  • Comparability post Manufacturing process changes for ATMPs
  • Handling & Supply – Product considerations, logistics, storage, supply, recall/destroy
  • Interacting with regulatory authorities
  • Introduction to CMC regulatory compliance
  • Understand emerging Regulatory trends and the importance of Regulatory compliance and quality for ATMPs
  • The criticality of Operational Excellence in ATMP manufacturing
  • Advanced risk management for ATMPs
  • Differences needed for autologous and allogeneic cell therapies
  • Key starting materials and classifications
  • Addressing CMC requirements in regulatory submissions for ATMPs
  • Learn how to conduct a comparability study
  • Understand QbD principles and how they relate to development, manufacturing, characterizations, and testing of ATMPs
  • Overview of global regulatory bodies and guidelines: learn how to interact with the regulatory agencies; manage discussions and defend studies and strategies
  • Avoid delays in clinical development and market approval
  • Ensuring quality and safety in ATMP development
  • How to deal with post-approval changes

CMC Regulatory Compliance for ATMPs

13 - 15 March 2024, Live Online Training
€1.850,00
Dr. Len Pattenden

Len has over 30 years of experience in both industry and academia. 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.

START TIMES

12:00 PM Vienna time

11:00 AM London time

7:00 AM New York time

4:00 AM Los Angeles time

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Course Description

This 3-day CMC regulatory compliance training is designed to keep you up to date on emerging ATMP topics. You will learn how to develop good CMC-compliant regulatory practices and avoid market-approval delays. This course is suitable for all those involved in CMC development and implementation for ATMPs.
  • Operational Excellence and alignment of business and CMC drivers
  • Important and emerging CMC regulatory issues – problems and challenges
  • CMC regulatory compliance for ATMPs – EMA & FDA
  • Quality Risk Management and Quality by Design (QbD) principles for ATMPs
  • Change management for ATMPs; FMEA de-risking, tech transfer and CMC activities
  • Non-GMP materials, systems and control – making compliance and phase-appropriate acceptance
  • Analytical, storage, stability, comparability and retention for ATMPs
  • Comparability post Manufacturing process changes for ATMPs
  • Handling & Supply – Product considerations, logistics, storage, supply, recall/destroy
  • Interacting with regulatory authorities
  • Introduction to CMC regulatory compliance
  • Understand emerging Regulatory trends and the importance of Regulatory compliance and quality for ATMPs
  • The criticality of Operational Excellence in ATMP manufacturing
  • Advanced risk management for ATMPs
  • Differences needed for autologous and allogeneic cell therapies
  • Key starting materials and classifications
  • Addressing CMC requirements in regulatory submissions for ATMPs
  • Learn how to conduct a comparability study
  • Understand QbD principles and how they relate to development, manufacturing, characterizations, and testing of ATMPs
  • Overview of global regulatory bodies and guidelines: learn how to interact with the regulatory agencies; manage discussions and defend studies and strategies
  • Avoid delays in clinical development and market approval
  • Ensuring quality and safety in ATMP development
  • How to deal with post-approval changes

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

CMC Regulatory Compliance for ATMPs

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

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