This course on Regulatory Affairs (RA) for Biologics and Biotechnology Products will provide an in-depth understanding of the regulatory framework and drug approval process for biologics. It will cover the development, manufacturing, and regulatory requirements for biologics, including drug delivery considerations, safety, Quality Control (QC), and Chemistry, Manufacturing, and Controls (CMC) requirements.
The course will start with an introduction to the science behind biologics and biotechnology products, including their development and production. Participants will learn about the various types of biologics, such as monoclonal antibodies, recombinant proteins, vaccines, and gene therapy products. They will also gain an understanding of the unique challenges and considerations that arise in the development of biologics, such as variability, heterogeneity, and immunogenicity.
Next, the course will focus on drug delivery considerations for biologics and the challenges that come with each method. Participants will also learn about the various drug delivery devices and the importance of ensuring their safety and efficacy.
The course will then cover the safety and QC requirements for biologics, including the need for extensive preclinical and clinical studies to establish safety and efficacy. Participants will also learn about the importance of post-market monitoring and pharmacovigilance to ensure ongoing product safety.
Finally, the course will cover the regulatory framework for biologics, including the different regulatory agencies responsible for overseeing biologics in various regions, such as Health Canada, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA). Participants will also gain an understanding of the drug approval process for biologics, including the various stages of regulatory review and the requirements for CMC data submission.
Throughout the course, case studies and examples will be used to illustrate key concepts and provide practical insights. By the end of the course, participants will have a comprehensive understanding of the regulatory requirements for biologics and biotechnology products, including drug delivery considerations, safety, QC and CMC requirements, and the drug approval process.