Regulatory Affairs & Compliance
Our courses on regulatory affairs and compliance cover the main submissions required for the development and marketing of medicinal products in Europe and the USA.
These include applications for approval to conduct clinical trials, to be granted orphan product status, to market new or generic products, and to make post-marketing changes.
Whether they are introductory courses for entry-level regulatory affairs and for support staff, or they are more advanced courses for more experienced staff, they provide both a training and a reference tool that is continually updated in response to developments in regulatory requirements.
Please select any of the below courses to look at detailed outlines of the modules, indicating what can be learnt and for whom it is most applicable.
Regulatory Affairs & Compliance courses
- SUB01: Orphan Drug Designation in the USA and Europe
- SUB02: The European Centralised Procedure (CP)
- SUB03: The Mutual Recognition Procedure (MRP)
- SUB04: Preparing Submissions in the Common Technical Document (CTD) Format
- SUB05: Electronic Common Technical Document (eCTD)
- SUB06: Variations to Marketing Authorisations in Europe
- SUB09: The New Drug Application (NDA) for Marketing Approval in the USA
- SUB11: The Decentralised Procedure (DCP)
- SUB12: Registration of Medicinal Products Based on Monoclonal Antibodies
- SUB13: How to Gain Approval to Market a Generic Drug in the USA
- SUB14: The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA
- ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products
- ESS02: Essentials of Monoclonal Antibodies
- CT01: How to Gain Approval to Conduct Clinical Trials in Europe
- CT10: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials