CMC

Pharma & Biotech

CMC Regulatory Compliance for ATMPs

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

LEARNING OBJECTIVES

Understanding emerging Regulatory trends 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

Translate an effective CMC strategy into your regulatory submission for ATMPs

Learn how to conduct a comparability study

Understand QbD principles and how they relate to development, manufacturing, characterizations, and testing of ATMPs.

Learn how to interact with the regulatory agencies; manage discussions and defend studies and strategies

Avoid delays in clinical development and market approval

How to deal with post-approval changes

KEY TOPICS

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

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

TRAINER

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.

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Video Invitation

Watch the video invitation from the trainer.