An Introduction to Clinical Trial Preparation and Design | Zenosis | 4 Hours | £ 200.00 |
An Introduction to Clinical Trials and Drug Development | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
An Introduction to Drug Safety and Pharmacovigilance | Zenosis | 2 Hours | £ 98.00 |
An Introduction to Good Manufacturing Practice for Medicinal Products | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
Clinical Trial Monitoring: Site Evaluation and Set-up | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
Clinical Trial Monitoring: Study Monitoring, Documentation and Closure | Zenosis | 2 Hours | £ 98.00 |
Commissioning and Installation Qualification | Zenosis | 1 Hour 30 Minutes | £ 120.00 |
Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
Computer Systems Validation, Part 1: Planning | Zenosis | 1 Hour | £ 120.00 |
Computer Systems Validation, Part 2: Implementation | Zenosis | 1 Hour | £ 120.00 |
Conducting Pharmacokinetic and Pharmacodynamic Studies | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture | Zenosis | 1 Hour | £ 39.00 |
Electronic Common Technical Document (eCTD) | Zenosis | 2 Hours 30 Minutes | £ 120.00 |
Equipment Cleaning Validation | Zenosis | 1 Hour 30 Minutes | £ 120.00 |
Essentials of EU and US Regulatory Affairs for Human Medicinal Products | Zenosis | 3 Hours | £ 149.00 |
Essentials of Monoclonal Antibodies | Zenosis | 1 Hour | £ 39.00 |
Good Clinical Practice Inspections and Audits | Zenosis | 2 Hours 30 Minutes | £ 120.00 |
Good Documentation Practice | Zenosis | 1 Hour | £ 39.00 |
Good Manufacturing Practice for the Warehouse | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
Good Manufacturing Practice in Cleaning and Sanitation | Zenosis | 1 Hour | £ 39.00 |
Good Manufacturing Practice in Packaging Medicinal Products | Zenosis | 1 Hour | £ 39.00 |
Good Manufacturing Practice in Processing Medicinal Products | Zenosis | 1 Hour | £ 39.00 |
Good Pharmacoepidemiology Practice | Zenosis | 1 Hour | £ 39.00 |
How to Gain Approval to Conduct Clinical Trials in Europe | Zenosis | 3 Hours | £ 149.00 |
How to Gain Approval to Market a Generic Drug in the USA | Zenosis | 3 Hours | £ 149.00 |
ICH Good Clinical Practice | Zenosis | 3 Hours | £ 149.00 |
Introduction to Validation | Zenosis | 1 Hour 30 Minutes | £ 120.00 |
Medical Devices - An Introduction to the Regulation of Medical Devices | Zenosis | 1 Hour | £ 49.00 |
Operational and Performance Qualification | Zenosis | 1 Hour | £ 120.00 |
Orphan Drug Designation in the USA and Europe | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
Preparing Submissions in the Common Technical Document (CTD) Format | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
Registration of Medicinal Products Based on Monoclonal Antibodies | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
Risk Management Planning for Medicinal Products | Zenosis | 1 Hour 30 Minutes | £ 61.00 |
Signal Detection and Management in Pharmacovigilance | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
The Decentralised Procedure (DCP) | Zenosis | 2 Hours | £ 98.00 |
The European Centralised Procedure (CP) | Zenosis | 1 Hour 30 Minutes | £ 74.00 |
The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials | Zenosis | 3 Hours | £ 149.00 |
The Mutual Recognition Procedure (MRP) | Zenosis | 2 Hours | £ 98.00 |
The New Drug Application (NDA) for Marketing Approval in the USA | Zenosis | 3 Hours 30 Minutes | £ 176.00 |
The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA | Zenosis | 30 Minutes | £ 25.00 |
Urgent Safety Restrictions | Zenosis | 45 Minutes | £ 39.00 |
Validation Plans and Documentation | Zenosis | 1 Hour 30 Minutes | £ 120.00 |
Variations to Marketing Authorisations in Europe | Zenosis | 3 Hours 30 Minutes | £ 176.00 |