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
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Zenosis is Intellego’s internet-based, regulatory and compliance learning-on-demand programme.
Zenosis is available as a remote or integrated solution for pharmaceutical, biotechnology or healthcare organisations irrespective of the number of users requiring access. This almost instantly deployable solution is a continually updated resource providing vital knowledge that will enable your staff to comply with regulatory requirements and increase productivity. This is offered at a cost substantially less than that of conventional training methods, resulting in increased return on investment.
Featuring high quality instructional design and expert content, all Zenosis modules are available “off-the-shelf” or can be tailored to fit your specific business-need.
We supply a substantial range of courses on regulatory affairs and compliance and on clinical trials, plus courses on aspects of Quality/CMC and drug safety.
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. Please click here to view our suite of courses for Regulatory Affairs and Compliance.
Our courses on clinical trials cover the design, set-up, monitoring and audit/inspection of trials. Please click here to view our suite of courses for Clinical Trials.