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Pharmaceutical

Title	Publisher	Enrolment Duration	Training Time
An Introduction to Clinical Trial Preparation and Design (CT04)	Zenosis	14 day eval	4 Hours
An Introduction to Clinical Trials and Drug Development (CT07)	Zenosis	14 day eval	1 Hour 30 Minutes
An Introduction to Drug Safety and Pharmacovigilance (PV03)	Zenosis	14 day eval	2 Hours
An Introduction to Good Manufacturing Practice for Medicinal Products (GMP01)	Zenosis	14 day eval	1 Hour 30 Minutes
An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration (PKPD01)	Zenosis	14 day eval	1 Hour 30 Minutes
Clinical Trial Monitoring: Site Evaluation and Set-up (CT06)	Zenosis	14 day eval	1 Hour 30 Minutes
Clinical Trial Monitoring: Study Monitoring, Documentation and Closure (CT08)	Zenosis	14 day eval	2 Hours
Clinical Trial Safety Reporting Requirements in the EU and USA (CT14)	Zenosis	14 day eval	2 Hours
Commissioning and Installation Qualification (VAL03)	Zenosis	14 day eval	1 Hour 30 Minutes
Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures (ICT01)	Zenosis	14 day eval	1 Hour 30 Minutes
Computer Systems Validation, Part 1: Planning (VAL06)	Zenosis	14 day eval	1 Hour
Computer Systems Validation, Part 2: Implementation (VAL07)	Zenosis	14 day eval	1 Hour
Conducting Pharmacokinetic and Pharmacodynamic Studies (PKPD02)	Zenosis	14 day eval	1 Hour 30 Minutes
Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA (SAM03)	Zenosis	14 day eval	1 Hour
Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture (GMP07)	Zenosis	14 day eval	1 Hour
Electronic Common Technical Document (eCTD) (SUB05)	Zenosis	14 day eval	2 Hours 30 Minutes
Equipment Cleaning Validation (VAL05)	Zenosis	14 day eval	1 Hour 30 Minutes
Essentials of EU and US Regulatory Affairs for Human Medicinal Products (ESS01)	Zenosis	14 day eval	3 Hours
Essentials of Monoclonal Antibodies (ESS02)	Zenosis	14 day eval	1 Hour
Good Clinical Practice Inspections and Audits (CT09)	Zenosis	14 day eval	2 Hours 30 Minutes
Good Documentation Practice (GMP02)	Zenosis	14 day eval	1 Hour
Good Manufacturing Practice for the Warehouse (GMP04)	Zenosis	14 day eval	1 Hour 30 Minutes
Good Manufacturing Practice in Cleaning and Sanitation (GMP03)	Zenosis	14 day eval	1 Hour
Good Manufacturing Practice in Packaging Medicinal Products (GMP06)	Zenosis	14 day eval	1 Hour
Good Manufacturing Practice in Processing Medicinal Products (GMP05)	Zenosis	14 day eval	1 Hour
Good Pharmacoepidemiology Practice (PV07)	Zenosis	14 day eval	1 Hour
Good Practices (GxP) in Drug Development and Manufacturing (GXP01)	Zenosis	14 day eval	30 Minutes
How to Conduct Clinical Research Under the EU Clinical Trials Regulation (CT12)	Zenosis	14 day eval	1 Hour
How to Gain Approval to Conduct Clinical Trials in Europe (CT01)	Zenosis	14 day eval	3 Hours
How to Gain Approval to Market a Generic Drug in the USA (SUB13)	Zenosis	14 day eval	3 Hours
How to Gain Authorisation for Clinical Research under the EU Clinical Trials Regulation (CT11)	Zenosis	14 day eval	2 Hours
ICH Good Clinical Practice (CT03)	Zenosis	14 day eval	3 Hours
Introduction to Validation (VAL01)	Zenosis	14 day eval	1 Hour 30 Minutes
Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA (SAM01)	Zenosis	14 day eval	1 Hour
Marketing of Prescription Drugs in the USA - Interactions with Healthcare Professionals (SAM04)	Zenosis	14 day eval	1 Hour
Medical Devices - An Introduction to the Regulation of Medical Devices (MD01)	Zenosis	14 day eval	1 Hour
Operational and Performance Qualification (VAL04)	Zenosis	14 day eval	1 Hour
Orphan Drug Designation in the USA and Europe (SUB01)	Zenosis	14 day eval	1 Hour 30 Minutes
Preparing Submissions in the Common Technical Document (CTD) Format (SUB04)	Zenosis	14 day eval	1 Hour 30 Minutes
Registration of Medicinal Products Based on Monoclonal Antibodies (SUB12)	Zenosis	14 day eval	1 Hour 30 Minutes
Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA (SAM02)	Zenosis	14 day eval	1 Hour 30 Minutes
Risk Management Planning for Medicinal Products (PV05)	Zenosis	14 day eval	1 Hour 30 Minutes
Safety Reporting in Clinical Trials (CT13)	Zenosis	14 day eval	2 Hours
Signal Detection and Management in Pharmacovigilance (PV04)	Zenosis	14 day eval	1 Hour 30 Minutes
The Decentralised Procedure (DCP) (SUB11)	Zenosis	14 day eval	2 Hours
The European Centralised Procedure (CP) (SUB02)	Zenosis	14 day eval	1 Hour 30 Minutes
The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials (CT10)	Zenosis	14 day eval	3 Hours
The Mutual Recognition Procedure (MRP) (SUB03)	Zenosis	14 day eval	2 Hours
The New Drug Application (NDA) for Marketing Approval in the USA (SUB09)	Zenosis	14 day eval	3 Hours 30 Minutes
The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA (SUB14)	Zenosis	14 day eval	30 Minutes
Urgent Safety Restrictions (PV06)	Zenosis	14 day eval	45 Minutes
Validation Plans and Documentation (VAL02)	Zenosis	14 day eval	1 Hour 30 Minutes
Variations to Marketing Authorisations in Europe (SUB06)	Zenosis	14 day eval	3 Hours 30 Minutes