This course will introduce the attendee to the historical development of vaccines, the different types (classes) of vaccines in use today, and will orient the attendee to the laws (PHSA, FD&CA) and regulations (ICH, FDA Guidance’s) required for vaccine development and commercialisation. The separate roles of FDA and CDC in the US will be discussed, and the regulatory pathways for marketing authorisation (MAA) of vaccines in the EU will be presented.

The basic bioprocess steps to produce bacterial and viral vaccines will be discussed with a focus on global regulatory guidance (ICH) and FDA Guidelines of importance. Requirements imposed on vaccine CMC development and commercialisation by the Public Health Service Act (PHSA) and the Food, Drug and Cosmetic Act (FD&CA) will be discussed. Quality control strategies for classes of vaccines will be presented.

An overview of the elements of the immune system will be presented and factors affecting the immune response to vaccines will be discussed. Immunological assays applied to certain vaccines in the measurement of quantity and potency will be highlighted.

We will conclude with an overview of therapeutic vaccine development strategies (vaccine types) regulated by CBER’s Office of Therapeutics and Advanced Therapies, followed by a more in-depth look at some vaccines developed globally to address the Covid-19 pandemic, with an examination of the unique production methods and drug product formulation requirements for the new class of mRNA vaccines and a view of the associated control testing of these products.

Who Should Attend

This 20-hour course is designed for senior management, directors, managers, supervisors, project planners, and professional staff seeking to obtain a broad understanding of vaccines and the regulation/Regulatory Guidelines, CMC development and quality assurance/control of vaccines for infectious disease or therapeutic indications. Typical attendees would include Regulatory Affairs, Quality, Product/Process Development and Project Management functions and Business Decision Makers.

The course can be customised to address specific organisational, departmental or functional issues and delivered on-site.

Please click here to register for this course.