Quality Regulatory Requirements for Biosimilars
Quality Regulatory Requirements for Biosimilars

Course Description

This 3-day CMC training is designed to keep you up to date on emerging strategies and practices relevant to the Quality Requirements and Regulatory landscape for Biosimilars. You will learn how to develop best Biosimilar development practices which are relevant for intended uses and regulatory compliance to avoid costly project and market-approval delays. This course is suitable for all those involved in Biosimilar workflows, where training is especially desired on Quality. Suitable for staff from R&D, process development and manufacturing areas including research scientists, process development, MSAT and manufacturing scientists and engineers, management and executive staff and Quality staff such as QC, QA, CMC and QPs.
  • Legal & Regulatory Framework
  • Scientific foundations of Biosimilar Development
  • QbD for Biosimilars
  • Regulatory pathways and submissions
  • Biologics Regulations for Biosimilars
  • Comparability, extrapolation & switching, Interchangeability
  • Analytical Quality considerations
  • References, Regulatory assistance and reliances
  • Change management: FMEA de-risking, tech transfer & CMC activities
  • Case studies – challenges & solutions (successful and unsuccessful cases)
  • Non-clinical and clinical studies
  • CMC assays & Control Strategy
  • Understanding emerging trends in the field of Biosimilars
  • The Regulatory frameworks and expectations relevant for Biosimilars
  • Differences in various stages – R&D, Process Development and Manufacturing
  • Key starting materials, classifications, references and standards
  • Understanding risk management
  • Quality by Design (QbD) and how to implement best practices
  • CMC strategies and control practices
  • Criticality of analytical quality
  • Important facets of comparability
  • Extrapolation guidelines
  • Clarified interchangeability and further Biosimilar guidances for designation
  • How to deal with changes

Quality & Regulatory Requirements for Biosimilars

20 - 22 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 training is designed to keep you up to date on emerging strategies and practices relevant to the Quality Requirements and Regulatory landscape for Biosimilars. You will learn how to develop best Biosimilar development practices which are relevant for intended uses and regulatory compliance to avoid costly project and market-approval delays. This course is suitable for all those involved in Biosimilar workflows, where training is especially desired on Quality. Suitable for staff from R&D, process development and manufacturing areas including research scientists, process development, MSAT and manufacturing scientists and engineers, management and executive staff and Quality staff such as QC, QA, CMC and QPs.
  • Legal & Regulatory Framework
  • Scientific foundations of Biosimilar Development
  • QbD for Biosimilars
  • Regulatory pathways and submissions
  • Biologics Regulations for Biosimilars
  • Comparability, extrapolation & switching, Interchangeability
  • Analytical Quality considerations
  • References, Regulatory assistance and reliances
  • Change management: FMEA de-risking, tech transfer & CMC activities
  • Case studies – challenges & solutions (successful and unsuccessful cases)
  • Non-clinical and clinical studies
  • CMC assays & Control Strategy
  • Understanding emerging trends in the field of Biosimilars
  • The Regulatory frameworks and expectations relevant for Biosimilars
  • Differences in various stages – R&D, Process Development and Manufacturing
  • Key starting materials, classifications, references and standards
  • Understanding risk management
  • Quality by Design (QbD) and how to implement best practices
  • CMC strategies and control practices
  • Criticality of analytical quality
  • Important facets of comparability
  • Extrapolation guidelines
  • Clarified interchangeability and further Biosimilar guidances for designation
  • How to deal with 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

Quality & Regulatory Requirements for Biosimilars

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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