Zenosis 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.

• SUB01: Orphan Drug Applications in the EU and USA
• 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
  
• SUB07: Registration of Monoclonal Antibodies
• SUB08: The ANDA: Requirements for Obtaining Approval for a Generic Product in the USA
  
• SUB09: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA
  
• SUB11: The Decentralised Procedure (DCP)
  
• ESS01: Essentials of EU and US Regulatory Affairs for Human Medicinal Products
  
• CT01: How to Obtain Approval to Conduct Clinical Trials in the EU
  
• CT10: The IND: How to Gain Approval for Clinical Trials in the USA