PDA EU00183 CMC Regulatory Compliance Strategy for Recombinant Proteins and Monoclonal Antibodies - Training / Workshop von PDA Europe gGmbH

Biopharmaceuticals (recombinant proteins, monoclonal antibodies, Fc-fusion proteins, fragment Fabs, bispecific antibodies, antibody-drug conjugates, and biosimilars) are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging manufacturing processes and complex products.

Frequently the development of the CMC regulatory strategy is an afterthought. This course will provide insights and practical guidance for the CMC teams to develop a cost-effective, risk-based CMC regulatory-compliant strategy for the manufacture and control of protein-based biopharmaceuticals from first-in-human (FIH) clinical studies through market approval. The course emphasis will include FDA, EMA, and ICH guidance. Real-world case examples of CMC regulatory compliance problems and delays affecting recombinant proteins, monoclonal antibodies, engineered antibodies, and biosimilars will be discussed.

Upon completion of this course, attendees will be able to:

• Understand the importance and underlying principles of an effective CMC regulatory strategy for biopharmaceuticals to move their products through clinical development into the marketplace
• Learn how to avoid major CMC delays in clinical development or market approval due to an ineffective CMC regulatory compliance strategy

This training course is intended for professionals who are involved in the manufacturing, quality and GMP compliance of ATMPs during clinical stages of development.

Departments REGULATORY AFFAIRS   RESEARCH AND DEVELOPMENT   QUALITY COMPLIANCE   MANUFACTURING   QUALITY ASSURANCE OPERATIONS   TECHNICAL OPERATIONS   TRAINING Roles AUDITOR/INSPECTOR   OPERATOR/TECHNICIAN   SUPERVISOR   SENIOR MANAGER   ENGINEER DIRECTOR