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CMC Regulatory Requirements for Biosimilars
CMC
Pharma & Biotech

CMC Regulatory Requirements for Biosimilars

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

Understanding emerging trends in the field of Biosimilars

Understanding emerging trends in the field of Biosimilars

Learning Objective

The Regulatory frameworks and expectations relevant for Biosimilars

The Regulatory frameworks and expectations relevant for Biosimilars

Learning Objective

Differences in various stages – R&D, Process Development and Manufacturing

Differences in various stages – R&D, Process Development and Manufacturing

Learning Objective

Key starting materials, classifications, references and standards

Key starting materials, classifications, references and standards

Learning Objective

Understanding risk management

Understanding risk management

Learning Objective

Quality by Design (QbD) and how to implement best practices

Quality by Design (QbD) and how to implement best practices

Learning Objective

CMC strategies and control practices

CMC strategies and control practices

Learning Objective

Criticality of analytical quality

Criticality of analytical quality

Learning Objective

Important facets of comparability

Important facets of comparability

Learning Objective

Extrapolation guidelines

Extrapolation guidelines

Learning Objective

Clarified interchangeability and further Biosimilar guidances for designation

Clarified interchangeability and further Biosimilar guidances for designation

Learning Objective

How to deal with changes

How to deal with changes



KEY TOPICS

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

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.

Learn More →

Video Invitation

Watch the video invitation from the trainer.