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