An Introduction to Clinical Trial Preparation and Design (CT04) |
Zenosis |
4 Hours |
£ 200.00 |
An Introduction to Clinical Trials and Drug Development (CT07) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
An Introduction to Drug Safety and Pharmacovigilance (PV03) |
Zenosis |
2 Hours |
£ 99.00 |
An Introduction to Good Manufacturing Practice for Medicinal Products (GMP01) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration (PKPD01) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
Assuring Data Integrity in Clinical Research |
Zenosis |
1 Hour |
£ 49.00 |
Assuring Data Integrity in the Manufacture of Medicinal Products |
Zenosis |
1 Hour |
£ 49.00 |
Clinical protocol design (CT04B) |
Zenosis |
45 Minutes |
£ 29.00 |
Clinical Research Teamwork (CT03B) |
Zenosis |
15 Minutes |
£ 15.00 |
Clinical study design (CT04F) |
Zenosis |
30 Minutes |
£ 29.00 |
Clinical Trial Documentation (CT03C) |
Zenosis |
30 Minutes |
£ 29.00 |
Clinical trial endpoints (CT04d) |
Zenosis |
30 Minutes |
£ 29.00 |
Clinical trial investigator's GCP responsibilities (CT03E) |
Zenosis |
30 Minutes |
£ 29.00 |
Clinical trial monitor's GCP responsibilities (CT03G) |
Zenosis |
30 Minutes |
£ 29.00 |
Clinical Trial Monitoring: Site Evaluation and Set-up (CT06) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
Clinical Trial Monitoring: Study Monitoring, Documentation and Closure (CT08) |
Zenosis |
2 Hours |
£ 99.00 |
Clinical Trial Preparation (CT04C) |
Zenosis |
45 Minutes |
£ 29.00 |
Clinical Trial Safety Reporting Requirements in the EU and USA (CT14) |
Zenosis |
2 Hours |
£ 99.00 |
Clinical trial sponsor's GCP responsibilities (CT03D) |
Zenosis |
30 Minutes |
£ 29.00 |
Clinical trials in drug development (CT04A) |
Zenosis |
30 Minutes |
£ 29.00 |
Commissioning and Installation Qualification (VAL03) |
Zenosis |
1 Hour 30 Minutes |
£ 99.00 |
Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures (ICT01) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
Computer Systems Validation, Part 1: Planning (VAL06) |
Zenosis |
1 Hour |
£ 99.00 |
Computer Systems Validation, Part 2: Implementation (VAL07) |
Zenosis |
1 Hour |
£ 99.00 |
Conducting Pharmacokinetic and Pharmacodynamic Studies (PKPD02) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA (SAM03) |
Zenosis |
1 Hour |
£ 99.00 |
Data capture (CT04G) |
Zenosis |
15 Minutes |
£ 15.00 |
Electronic Common Technical Document (eCTD) (SUB05) |
Zenosis |
2 Hours 30 Minutes |
£ 120.00 |
Equipment Cleaning Validation (VAL05) |
Zenosis |
1 Hour 30 Minutes |
£ 99.00 |
Essentials of EU and US Regulatory Affairs for Human Medicinal Products (ESS01) |
Zenosis |
3 Hours |
£ 149.00 |
Good Clinical Laboratory Practice (GLP03) |
Zenosis |
1 Hour |
£ 61.00 |
Good Clinical Practice Inspections and Audits (CT09) |
Zenosis |
2 Hours 30 Minutes |
£ 120.00 |
Good Laboratory Practice |
Zenosis |
1 Hour |
£ 74.00 |
Good Manufacturing Practice for the Warehouse (GMP04) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
Good Practices (GxP) in Drug Development and Manufacturing (GXP01) |
Zenosis |
30 Minutes |
£ 29.00 |
Good Quality Control Laboratory Practice (GLP02) |
Zenosis |
1 Hour |
£ 74.00 |
How to Conduct Clinical Research Under the EU Clinical Trials Regulation (CT12) |
Zenosis |
1 Hour |
£ 49.00 |
How to Gain Approval to Conduct Clinical Trials in Europe (CT01) |
Zenosis |
3 Hours |
£ 149.00 |
How to Gain Approval to Market a Generic Drug in the USA (SUB13) |
Zenosis |
3 Hours |
£ 149.00 |
How to Gain Authorisation for Clinical Research under the EU Clinical Trials Regulation (CT11) |
Zenosis |
2 Hours |
£ 99.00 |
ICH Good Clinical Practice (CT03) |
Zenosis |
3 Hours |
£ 149.00 |
ICH, Harmonisation and Principles of Good Clinical Practice (CT03A) |
Zenosis |
15 Minutes |
£ 15.00 |
Informed Consent in Clinical Trials (CT03F) |
Zenosis |
15 Minutes |
£ 15.00 |
Introduction to Validation (VAL01) |
Zenosis |
1 Hour 30 Minutes |
£ 99.00 |
Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA (SAM01) |
Zenosis |
1 Hour |
£ 99.00 |
Marketing of Prescription Drugs in the USA - Interactions with Healthcare Professionals (SAM04) |
Zenosis |
1 Hour |
£ 99.00 |
Medical Devices - An Introduction to the Regulation of Medical Devices (MD01) |
Zenosis |
1 Hour |
£ 49.00 |
Operational and Performance Qualification (VAL04) |
Zenosis |
1 Hour |
£ 99.00 |
Orphan Drug Designation in the USA and Europe (SUB01) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
Preparing Submissions in the Common Technical Document (CTD) Format (SUB04) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
Registration of Medicinal Products Based on Monoclonal Antibodies (SUB12) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA (SAM02) |
Zenosis |
1 Hour 30 Minutes |
£ 99.00 |
Risk Management Planning for Medicinal Products (PV05) |
Zenosis |
1 Hour 30 Minutes |
£ 61.00 |
Safety Reporting in Clinical Trials (CT13) |
Zenosis |
2 Hours |
£ 99.00 |
Signal Detection and Management in Pharmacovigilance (PV04) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
Statistical elements (CT04E) |
Zenosis |
30 Minutes |
£ 29.00 |
The 505(b)(2) Application for Marketing Approval in the USA |
Zenosis |
30 Minutes |
£ 61.00 |
The Biologics License Application (BLA) for Marketing Approval in the USA (SUB15) |
Zenosis |
3 Hours 30 Minutes |
£ 99.00 |
The Decentralised Procedure (DCP) (SUB11) |
Zenosis |
2 Hours |
£ 99.00 |
The European Centralised Procedure (CP) (SUB02) |
Zenosis |
1 Hour 30 Minutes |
£ 74.00 |
The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials (CT10) |
Zenosis |
3 Hours |
£ 149.00 |
The Mutual Recognition Procedure (MRP) (SUB03) |
Zenosis |
2 Hours |
£ 99.00 |
The New Drug Application (NDA) for Marketing Approval in the USA (SUB09) |
Zenosis |
3 Hours 30 Minutes |
£ 176.00 |
The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA (SUB14) |
Zenosis |
30 Minutes |
£ 29.00 |
Validation Plans and Documentation (VAL02) |
Zenosis |
1 Hour 30 Minutes |
£ 99.00 |
Variations to Marketing Authorisations in Europe (SUB06) |
Zenosis |
3 Hours 30 Minutes |
£ 176.00 |
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