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Zenosis

Titel Publisher Enrolment Duration Training Time
An Introduction to Clinical Trial Preparation and Design (CT04) Zenosis 3 months 4 Hours
An Introduction to Clinical Trials and Drug Development (CT07) Zenosis 3 months 1 Hour 30 Minutes
An Introduction to Drug Safety and Pharmacovigilance (PV03) Zenosis 3 months 2 Hours
An Introduction to Good Manufacturing Practice for Medicinal Products (GMP01) Zenosis 3 months 1 Hour 30 Minutes
An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration (PKPD01) Zenosis 3 months 1 Hour 30 Minutes
Clinical protocol design (CT04B) Zenosis 3 months 45 Minutes
Clinical Research Teamwork (CT03B) Zenosis 3 months 15 Minutes
Clinical study design (CT04F) Zenosis 3 months 30 Minutes
Clinical Trial Documentation (CT03C) Zenosis 3 months 30 Minutes
Clinical trial endpoints (CT04d) Zenosis 3 months 30 Minutes
Clinical trial investigator's GCP responsibilities (CT03E) Zenosis 3 months 30 Minutes
Clinical trial monitor's GCP responsibilities (CT03G) Zenosis 3 months 30 Minutes
Clinical Trial Monitoring: Site Evaluation and Set-up (CT06) Zenosis 3 months 1 Hour 30 Minutes
Clinical Trial Monitoring: Study Monitoring, Documentation and Closure (CT08) Zenosis 3 months 2 Hours
Clinical Trial Preparation (CT04C) Zenosis 3 months 45 Minutes
Clinical Trial Safety Reporting Requirements in the EU and USA (CT14) Zenosis 3 months 2 Hours
Clinical trial sponsor's GCP responsibilities (CT03D) Zenosis 3 months 30 Minutes
Clinical trials in drug development (CT04A) Zenosis 3 months 30 Minutes
Commissioning and Installation Qualification (VAL03) Zenosis 3 months 1 Hour 30 Minutes
Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures (ICT01) Zenosis 3 months 1 Hour 30 Minutes
Computer Systems Validation, Part 1: Planning (VAL06) Zenosis 3 months 1 Hour
Computer Systems Validation, Part 2: Implementation (VAL07) Zenosis 3 months 1 Hour
Conducting Pharmacokinetic and Pharmacodynamic Studies (PKPD02) Zenosis 3 months 1 Hour 30 Minutes
Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA (SAM03) Zenosis 3 months 1 Hour
Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture (GMP07) Zenosis 3 months 1 Hour
Data capture (CT04G) Zenosis 3 months 15 Minutes
Documentation (GMP01) Zenosis 3 months 30 Minutes
Electronic Common Technical Document (eCTD) (SUB05) Zenosis 3 months 2 Hours 30 Minutes
Equipment Cleaning Validation (VAL05) Zenosis 3 months 1 Hour 30 Minutes
Essentials of EU and US Regulatory Affairs for Human Medicinal Products (ESS01) Zenosis 3 months 3 Hours
Essentials of Monoclonal Antibodies (ESS02) Zenosis 3 months 1 Hour
GMP – what and why Zenosis 3 months 30 Minutes
Good Clinical Laboratory Practice (GLP03) Zenosis 3 months 1 Hour
Good Clinical Practice Inspections and Audits (CT09) Zenosis 3 months 2 Hours 30 Minutes
Good Documentation Practice (GMP02) Zenosis 3 months 1 Hour
Good Laboratory Practice Zenosis 3 months 1 Hour
Good Manufacturing Practice for the Warehouse (GMP04) Zenosis 3 months 1 Hour 30 Minutes
Good Manufacturing Practice in Cleaning and Sanitation (GMP03) Zenosis 3 months 1 Hour
Good Manufacturing Practice in Packaging Medicinal Products (GMP06) Zenosis 3 months 1 Hour
Good Manufacturing Practice in Processing Medicinal Products (GMP05) Zenosis 3 months 1 Hour
Good Pharmacoepidemiology Practice (PV07) Zenosis 3 months 1 Hour
Good Practices (GxP) in Drug Development and Manufacturing (GXP01) Zenosis 3 months 30 Minutes
Good Quality Control Laboratory Practice (GLP02) Zenosis 3 months 1 Hour
How to Conduct Clinical Research Under the EU Clinical Trials Regulation (CT12) Zenosis 3 months 1 Hour
How to Gain Approval to Conduct Clinical Trials in Europe (CT01) Zenosis 3 months 3 Hours
How to Gain Approval to Market a Generic Drug in the USA (SUB13) Zenosis 3 months 3 Hours
How to Gain Authorisation for Clinical Research under the EU Clinical Trials Regulation (CT11) Zenosis 3 months 2 Hours
Hygiene cleaning and sanitation (GMP01c) Zenosis 3 months 30 Minutes
ICH Good Clinical Practice (CT03) Zenosis 3 months 3 Hours
ICH, Harmonisation and Principles of Good Clinical Practice (CT03A) Zenosis 3 months 15 Minutes
Informed Consent in Clinical Trials (CT03F) Zenosis 3 months 15 Minutes
Introduction to Validation (VAL01) Zenosis 3 months 1 Hour 30 Minutes
Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA (SAM01) Zenosis 3 months 1 Hour
Marketing of Prescription Drugs in the USA - Interactions with Healthcare Professionals (SAM04) Zenosis 3 months 1 Hour
Medical Devices - An Introduction to the Regulation of Medical Devices (MD01) Zenosis 3 months 1 Hour
Operational and Performance Qualification (VAL04) Zenosis 3 months 1 Hour
Orphan Drug Designation in the USA and Europe (SUB01) Zenosis 3 months 1 Hour 30 Minutes
Preparing Submissions in the Common Technical Document (CTD) Format (SUB04) Zenosis 3 months 1 Hour 30 Minutes
Principles of GMP (GMP01b) Zenosis 3 months 30 Minutes
Registration of Medicinal Products Based on Monoclonal Antibodies (SUB12) Zenosis 3 months 1 Hour 30 Minutes
Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA (SAM02) Zenosis 3 months 1 Hour 30 Minutes
Risk Management Planning for Medicinal Products (PV05) Zenosis 3 months 1 Hour 30 Minutes
Safety Reporting in Clinical Trials (CT13) Zenosis 3 months 2 Hours
Signal Detection and Management in Pharmacovigilance (PV04) Zenosis 3 months 1 Hour 30 Minutes
Statistical elements (CT04E) Zenosis 3 months 30 Minutes
The 505(b)(2) Application for Marketing Approval in the USA Zenosis 3 months 30 Minutes
The Biologics License Application (BLA) for Marketing Approval in the USA (SUB15) Zenosis 3 months 3 Hours 30 Minutes
The Decentralised Procedure (DCP) (SUB11) Zenosis 3 months 2 Hours
The European Centralised Procedure (CP) (SUB02) Zenosis 3 months 1 Hour 30 Minutes
The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials (CT10) Zenosis 3 months 3 Hours
The Mutual Recognition Procedure (MRP) (SUB03) Zenosis 3 months 2 Hours
The New Drug Application (NDA) for Marketing Approval in the USA (SUB09) Zenosis 3 months 3 Hours 30 Minutes
The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA (SUB14) Zenosis 3 months 30 Minutes
Urgent Safety Restrictions (PV06) Zenosis 3 months 45 Minutes
Validation Plans and Documentation (VAL02) Zenosis 3 months 1 Hour 30 Minutes
Variations to Marketing Authorisations in Europe (SUB06) Zenosis 3 months 3 Hours 30 Minutes

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