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