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An Introduction to Clinical Trial Preparation and Design (CT04)
Publisher
Zenosis
Duration
4 Hours
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An Introduction to Clinical Trials and Drug Development (CT07)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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An Introduction to Drug Safety and Pharmacovigilance (PV03)
Publisher
Zenosis
Duration
2 Hours
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An Introduction to Good Manufacturing Practice for Medicinal Products (GMP01)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration (PKPD01)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Assuring Data Integrity in Clinical Research
Publisher
Zenosis
Duration
1 Hour
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Assuring Data Integrity in the Manufacture of Medicinal Products
Publisher
Zenosis
Duration
1 Hour
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Clinical Investigator's ICH E6(R3) GCP Responsibilities (CT03E)
Publisher
Zenosis
Duration
30 Minutes
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Clinical protocol design (CT04B)
Publisher
Zenosis
Duration
45 Minutes
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Clinical research teamwork (CT03H)
Publisher
Zenosis
Duration
15 Minutes
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Clinical study design (CT04F)
Publisher
Zenosis
Duration
30 Minutes
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Clinical trial endpoints (CT04d)
Publisher
Zenosis
Duration
30 Minutes
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Clinical Trial Monitoring: Site Evaluation and Set-up (CT06)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Clinical Trial Monitoring: Study Monitoring, Documentation and Closure (CT08)
Publisher
Zenosis
Duration
2 Hours
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Clinical Trial Preparation (CT04C)
Publisher
Zenosis
Duration
45 Minutes
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Clinical Trial Safety Reporting Requirements in the EU and USA (CT14)
Publisher
Zenosis
Duration
2 Hours
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Clinical Trial Sponsor's ICH E6(R3) GCP Responsibilities (CT03D)
Publisher
Zenosis
Duration
30 Minutes
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Clinical Trial Sponsor's ICH E6(R3) GCP Responsibilities for Monitoring (CT03G)
Publisher
Zenosis
Duration
30 Minutes
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Clinical trials in drug development (CT04A)
Publisher
Zenosis
Duration
30 Minutes
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Commissioning and Installation Qualification (VAL03)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures (ICT01)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Computer Systems Validation, Part 1: Planning (VAL06)
Publisher
Zenosis
Duration
1 Hour
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Computer Systems Validation, Part 2: Implementation (VAL07)
Publisher
Zenosis
Duration
1 Hour
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Conducting Pharmacokinetic and Pharmacodynamic Studies (PKPD02)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA (SAM03)
Publisher
Zenosis
Duration
1 Hour
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Data Capture and Management in Clinical Trials (CT04G)
Publisher
Zenosis
Duration
15 Minutes
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Electronic Common Technical Document (eCTD) (SUB05)
Publisher
Zenosis
Duration
2 Hours 30 Minutes
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Equipment Cleaning Validation (VAL05)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Essentials of EU and US Regulatory Affairs for Human Medicinal Products (ESS01)
Publisher
Zenosis
Duration
3 Hours
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Good Clinical Laboratory Practice (GLP03)
Publisher
Zenosis
Duration
1 Hour
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Good Clinical Practice Inspections and Audits (CT09)
Publisher
Zenosis
Duration
2 Hours 30 Minutes
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Good Laboratory Practice
Publisher
Zenosis
Duration
1 Hour
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Good Manufacturing Practice for the Warehouse (GMP04)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Good Practices (GxP) in Drug Development and Manufacturing (GXP01)
Publisher
Zenosis
Duration
30 Minutes
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Good Quality Control Laboratory Practice (GLP02)
Publisher
Zenosis
Duration
1 Hour
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How to Conduct Clinical Research Under the EU Clinical Trials Regulation (CT12)
Publisher
Zenosis
Duration
1 Hour
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How to Gain and Maintain Approval for Clinical Research Under the EU Clinical Trials Directive (CT01)
Publisher
Zenosis
Duration
3 Hours
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How to Gain Approval to Market a Generic Drug in the USA (SUB13)
Publisher
Zenosis
Duration
3 Hours
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How to Gain Authorisation for Clinical Research under the EU Clinical Trials Regulation (CT11)
Publisher
Zenosis
Duration
2 Hours
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ICH and Harmonisation of Requirements for Clinical Research (CT03A)
Publisher
Zenosis
Duration
15 Minutes
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ICH E6(R3) GCP Expectations for Records and Data Governance (CT03C)
Publisher
Zenosis
Duration
30 Minutes
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ICH E6(R3) Good Clinical Practice (CT03)
Publisher
Zenosis
Duration
3 Hours
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Informed Consent in Clinical Trials (CT03F)
Publisher
Zenosis
Duration
15 Minutes
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Introduction to Validation (VAL01)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA (SAM01)
Publisher
Zenosis
Duration
1 Hour
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Marketing of Prescription Drugs in the USA - Interactions with Healthcare Professionals (SAM04)
Publisher
Zenosis
Duration
1 Hour
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Medical Devices - An Introduction to the Regulation of Medical Devices (MD01)
Publisher
Zenosis
Duration
1 Hour
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Operational and Performance Qualification (VAL04)
Publisher
Zenosis
Duration
1 Hour
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Orphan Drug Designation in the USA and Europe (SUB01)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Preparing Submissions in the Common Technical Document (CTD) Format (SUB04)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Principles of ICH E6(R3) Good Clinical Practice (CT03B)
Publisher
Zenosis
Duration
15 Minutes
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Quality Management System Requirements for Medical Devices under ISO 13485:2016 and FDA QMSR (MD02)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Registration of Medicinal Products Based on Monoclonal Antibodies (SUB12)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA (SAM02)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Risk Management Planning for Medicinal Products (PV05)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Safety Reporting in Clinical Trials (CT13)
Publisher
Zenosis
Duration
2 Hours
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Signal Detection and Management in Pharmacovigilance (PV04)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Statistical Elements of Clinical Trials (CT04E)
Publisher
Zenosis
Duration
30 Minutes
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The 505(b)(2) Application for Marketing Approval in the USA
Publisher
Zenosis
Duration
30 Minutes
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The Biologics License Application (BLA) for Marketing Approval in the USA (SUB15)
Publisher
Zenosis
Duration
3 Hours 30 Minutes
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The Decentralised Procedure (DCP) (SUB11)
Publisher
Zenosis
Duration
2 Hours
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The European Centralised Procedure (CP) (SUB02)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials (CT10)
Publisher
Zenosis
Duration
3 Hours
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The Mutual Recognition Procedure (MRP) (SUB03)
Publisher
Zenosis
Duration
2 Hours
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The New Drug Application (NDA) for Marketing Approval in the USA (SUB09)
Publisher
Zenosis
Duration
3 Hours 30 Minutes
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The Regulatory Pathway to Approval of Follow-on Biologics (Biosimilars) in the USA (SUB14)
Publisher
Zenosis
Duration
30 Minutes
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Validation Plans and Documentation (VAL02)
Publisher
Zenosis
Duration
1 Hour 30 Minutes
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Variations to Marketing Authorisations in Europe (SUB06)
Publisher
Zenosis
Duration
3 Hours 30 Minutes
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