About Zenosis
Benefits of Zenosis
Zenosis Regulatory Affairs & Compliance
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
Zenosis Clinical Trials
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
GMP/CMC
Drug Safety & Pharmacovigilance
Request a Zenosis Trial
Zenosis Terms & Conditions
Pathways Summary
Benefits of Zenosis
The benefits of Zenosis e-Learning to an organisation and end user include:
24/7 learning – Users can access courses when they want. For example at work, at home or when travelling.
Always up to date – New information allows the end user to always be in touch with changing regulations and legislations.
No geographical barriers – Bringing users together from various locations on a specific date is eradicated.
User overheads are lower - No travel, accommodation, or food costs to account for.
Flexibility – The end-user is able to skip through information they may already know, and a beginner has up to a year to access the information if they need it or simply for reference.
Self paced learning – This allows the user to learn at their own speed; to stop and start as they choose.
Course design – We can amend or change a course to meet specific company needs.
Greener – The company’s carbon foot print is reduced with no travel.