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Zenosis® is a regulatory and compliance eLearning library for the medicinal and pharmaceutical products sector. All Zenosis® courses have been accredited with CPD points by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom. The courses are updated regularly with up-to-date statistical data, and with vital changed to any industry, regulatory, governmental or other factors. The Zenosis® courses feature high quality instructional design and expert content, and all Zenosis® modules are available “off-the-shelf” or can be tailored to fit your specific business-need.

TitlePublisherTraining TimeBase Price
An Introduction to Clinical Trial Preparation and DesignZenosis4 Hours£ 200.00
An Introduction to Clinical Trials and Drug DevelopmentZenosis1 Hour 30 Minutes£ 74.00
An Introduction to Drug Safety and PharmacovigilanceZenosis2 Hours£ 98.00
An Introduction to Good Manufacturing Practice for Medicinal ProductsZenosis1 Hour 30 Minutes£ 74.00
An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and RegistrationZenosis1 Hour 30 Minutes£ 74.00
Clinical Trial Monitoring: Site Evaluation and Set-upZenosis1 Hour 30 Minutes£ 74.00
Clinical Trial Monitoring: Study Monitoring, Documentation and ClosureZenosis2 Hours£ 98.00
Commissioning and Installation QualificationZenosis1 Hour 30 Minutes£ 120.00
Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures Zenosis1 Hour 30 Minutes£ 74.00
Computer Systems Validation, Part 1: PlanningZenosis1 Hour£ 120.00
Computer Systems Validation, Part 2: ImplementationZenosis1 Hour£ 120.00
Conducting Pharmacokinetic and Pharmacodynamic StudiesZenosis1 Hour 30 Minutes£ 74.00
Corrective and Preventive Action (CAPA) in Medicinal Products ManufactureZenosis1 Hour£ 39.00
Electronic Common Technical Document (eCTD)Zenosis2 Hours 30 Minutes£ 120.00
Equipment Cleaning ValidationZenosis1 Hour 30 Minutes£ 120.00
Essentials of EU and US Regulatory Affairs for Human Medicinal ProductsZenosis3 Hours£ 149.00
Essentials of Monoclonal AntibodiesZenosis1 Hour£ 39.00
Good Clinical Practice Inspections and AuditsZenosis2 Hours 30 Minutes£ 120.00
Good Documentation PracticeZenosis1 Hour£ 39.00
Good Manufacturing Practice for the WarehouseZenosis1 Hour 30 Minutes£ 74.00
Good Manufacturing Practice in Cleaning and SanitationZenosis1 Hour£ 39.00
Good Manufacturing Practice in Packaging Medicinal ProductsZenosis1 Hour£ 39.00
Good Manufacturing Practice in Processing Medicinal ProductsZenosis1 Hour£ 39.00
Good Pharmacoepidemiology PracticeZenosis1 Hour£ 39.00
How to Gain Approval to Conduct Clinical Trials in EuropeZenosis3 Hours£ 149.00
How to Gain Approval to Market a Generic Drug in the USAZenosis3 Hours£ 149.00
ICH Good Clinical PracticeZenosis3 Hours£ 149.00
Introduction to ValidationZenosis1 Hour 30 Minutes£ 120.00
Medical Devices - An Introduction to the Regulation of Medical DevicesZenosis1 Hour£ 49.00
Operational and Performance QualificationZenosis1 Hour£ 120.00
Orphan Drug Designation in the USA and EuropeZenosis1 Hour 30 Minutes£ 74.00
Preparing Submissions in the Common Technical Document (CTD) FormatZenosis1 Hour 30 Minutes£ 74.00
Registration of Medicinal Products Based on Monoclonal AntibodiesZenosis1 Hour 30 Minutes£ 74.00
Risk Management Planning for Medicinal ProductsZenosis1 Hour 30 Minutes£ 61.00
Signal Detection and Management in PharmacovigilanceZenosis1 Hour 30 Minutes£ 74.00
The Decentralised Procedure (DCP)Zenosis2 Hours£ 98.00
The European Centralised Procedure (CP) Zenosis1 Hour 30 Minutes£ 74.00
The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical TrialsZenosis3 Hours£ 149.00
The Mutual Recognition Procedure (MRP)Zenosis2 Hours£ 98.00
The New Drug Application (NDA) for Marketing Approval in the USAZenosis3 Hours 30 Minutes£ 176.00
The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USAZenosis30 Minutes£ 25.00
Urgent Safety RestrictionsZenosis45 Minutes£ 39.00
Validation Plans and DocumentationZenosis1 Hour 30 Minutes£ 120.00
Variations to Marketing Authorisations in EuropeZenosis3 Hours 30 Minutes£ 176.00