CMC Regulatory Compliance for Biological Drug Products
CMC Regulatory Compliance for Biological Drug Products

Course Description

This 3-day CMC regulatory compliance training is designed to keep you up to date on emerging biological products. 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.
  • CMC regulatory compliance for biologics – EMA & FDA
  • Quality by Design (QbD) principles for biologics manufacturing
  • Change management for biologics
  • Analytical, stability and biological comparability studies
  • Biological comparability post Manufacturing process changes
  • Interacting with regulatory authorities
  • Translate an effective biologics CMC strategy into an effective regulatory submission
  • Learn how to conduct a comparability study
  • Understand QbD principles and how they relate to development, manufacturing, characterizations, and testing of biologic products.
  • Learn how to interact with the regulatory agencies; manage discussions and defend studies
  • Avoid delays in clinical development and market approval
  • How to deal with post-approval changes

CMC Regulatory Compliance for Biological Drug Products (US)

2 - 4 October 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

5:00 PM Vienna time

4:00 PM London time

11:00 AM New York time

8:00 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 biological products. 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.
  • CMC regulatory compliance for biologics – EMA & FDA
  • Quality by Design (QbD) principles for biologics manufacturing
  • Change management for biologics
  • Analytical, stability and biological comparability studies
  • Biological comparability post Manufacturing process changes
  • Interacting with regulatory authorities
  • Translate an effective biologics CMC strategy into an effective regulatory submission
  • Learn how to conduct a comparability study
  • Understand QbD principles and how they relate to development, manufacturing, characterizations, and testing of biologic products.
  • Learn how to interact with the regulatory agencies; manage discussions and defend studies
  • Avoid delays in clinical development and market approval
  • 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 Biological Drug Products (US)

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

Medical-Devices-Certificate-Course

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