Manufacturing and Production

Regulatory Affairs and Dossier Preparation for Medicines

A registration dossier is assessed by people who will never see the factory, so the file has to answer questions before they are asked and be internally consistent in every place a reviewer can cross check. This course covers building one. Delegates work through the common technical document structure and what belongs in each module. Quality documentation is covered in detail, since that is where most queries originate: drug substance, drug product, control of excipients, container closure and stability. Specification setting and justification follow. Bioequivalence requirements are addressed for generic products, including when a study is needed and when a waiver applies. Regional requirements are covered for the medicines regulators of the region, along with the harmonisation initiatives changing them. Variations, renewals and lifecycle management follow. Responding to a query is treated as a skill, including what not to volunteer. Good manufacturing practice inspection linkage is addressed. The course closes on submission planning and on the timelines a launch depends on.