Principal Regulatory Writer Certara Drug Development Solutions
Description: In chemistry, manufacturing, and controls (CMC) regulatory writing, there is a difference in the level of detail required for New Drug Applications (NDAs) and Biologic License Application (BLAs [including vaccines]) supporting different types of products. The expectations tend to diminish as time elapses and the regulatory authority becomes more familiar with a specific type of medicinal product. Small molecule oral solid products have been submitted to and approved by regulatory authorities more frequently and represent a different set of expectations than are expected for vaccines and biologics. Vaccines and biologics tend to be rather comparable to each other yet they contain significant differences in requirements for certain modules. This seminar will provide a high-level overview of the expectations required for Module 3 submissions for a small molecule oral solid product NDA, a parenteral biologic BLA, and a vaccine BLA. We will start with the small molecule oral solid, move to the biologic, then finish with the vaccine. The presentations will be followed by a question answer period.
Learning Objectives:
Participants will gain an understanding of the basic format of Module 3 for a small molecule, with a brief discussion of post approval changes for a small molecule oral solid
Participants will be able to describe differences between a small molecule, biologic, and vaccine application. This discussion will also include a brief discussion of post approval changes for a biologic.
Participants will gain a basic overview of the regulatory hurdles that need to be overcome for development of a vaccine.
