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
CT03: An Introduction to ICH Good Clinical Practice (ICHJ-GCP)
CT04: An Introduction to Clinical Trial Preparation and Design
CT05: An Introduction to Clinical Trials in India
CT06: Clinical Trial Monitoring: Site Evaluation and Setup
CT07: Introduction to Clinical Trials and Drug Development
CT08: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
CT09: Preparing for a GCP Audit or Inspection
SC01: Pharmacokinetics and Pharmacodynamics in Drug Registration
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
Our courses on clinical trials cover the design, set-up, monitoring and audit/inspection of trials. We offer modules providing extensive training for clinical research associates and other staff of pharma/biotech or contract research organisations involved in clinical development. We also offer modules of value both to such staff and to clinical investigators.
At a time of upheaval in the legislation on clinical research, our continually updated courses provide an essential guide to requirements and best practice.
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.
Other suggested courses include:
Please click here for a no obligation trial to demo a course that interests you.