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
- SUB15: The Biologics License Application (BLA) for Marketing Approval in the USA
- SUB16: The 505(b)(2) Application for Marketing Approval in the USA
- ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products
- ESS02: Essentials of Monoclonal Antibodies
- CT01: How to Gain and Maintain Approval for Clinical Research Under the EU Clinical Trials Directive
- CT10: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials
- CT11: How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation
- CT12: How to Conduct Clinical Research Under the EU Clinical Trials Regulation
- CT13: Safety Reporting in Clinical Trials
- CT14: Clinical Trial Safety Reporting Requirements in the EU and USA
- GXP01: Good Practices (GxP) in Drug Development and Manufacturing