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Topic Areas
(click on a box to see all the available courses)
ICH E6 Good Clinical Practice (CT03)
Clinical Trial Monitoring: Site Evaluation and Setup (CT06)
An Introduction to Clinical Trials and Drug Development (CT07)
Clinical Trial Monitoring: Study Monitoring, Documentation and Closure (CT08)
Good Clinical Practice Inspections and Audits (CT09)
How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation (CT11)
How to Conduct Clinical Research Under the EU Clinical Trials Regulation (CT12)
An Introduction to Drug Safety and Pharmacovigilance (PV03)
Signal Detection and Management in Pharmacovigilance (PV04)
Risk Management Planning for Medicinal Products (PV05)
Urgent Safety Restrictions (PV06)
Good Pharmacoepidemiology Practice (PV07)
An Introduction to Good Manufacturing Practice for Medicinal Products (GMP01)
Good Documentation Practice (GMP02)
Good Manufacturing Practice in Cleaning and Sanitation (GMP03)
Good Manufacturing Practice for the Warehouse (GMP04)
Good Manufacturing Practice in Processing Medicinal Products (GMP05)
Good Manufacturing Practice in Packaging Medicinal Products (GMP06)
Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture (GMP07)
An Introduction to the Regulation of Medical Devices (MD01)
An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration (PKPD01)
Conducting Pharmacokinetic and Pharmacodynamic Studies (PKPD02)
Introduction to Validation (VAL01)
Validation Plans and Documentation (VAL02)
Commissioning and Installation Qualification (VAL03)
Operational and Performance Qualification (VAL04)
Equipment Cleaning Validation (VAL05)
Computer Systems Validation, Part 1: Planning (VAL06)
Computer Systems Validation, Part 2: Implementation (VAL07)
Orphan Drug Designation in the USA and Europe (SUB01)
The European Centralised Procedure (CP) (SUB02)
The Mutual Recognition Procedure (MRP) (SUB03)
Preparing Submissions in the Common Technical Document (CTD) Format (SUB04)
Electronic Common Technical Document (eCTD) (SUB05)
Variations to Marketing Authorisations in Europe (SUB06)
The New Drug Application (NDA) for Marketing Approval in the USA (SUB09)
The Decentralised Procedure (DCP) (SUB11)
Registration of Medicinal Products Based on Monoclonal Antibodies (SUB12)
How to Gain Approval to Market a Generic Drug in the USA (SUB13)
The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA (SUB14)
Essentials of EU and US Regulatory Affairs for Human Medicinal Products (ESS01)
Essentials of Monoclonal Antibodies (ESS02)
How to Gain Approval to Conduct Clinical Trials in Europe (CT01)
The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials (CT10)
How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation (CT11)
How to Conduct Clinical Research Under the EU Clinical Trials Regulation (CT12)
Essentials of EU and US Regulatory Affairs for Human Medicinal Products (ESS01)
Essentials of Monoclonal Antibodies (ESS02)
An Introduction to Good Manufacturing Practice for Medicinal Products (GMP01)
An Introduction to Clinical Trials and Drug Development (CT07)
ICH E6 Good Clinical Practice (CT03)
An Introduction to Clinical Trial Preparation and Design (CT04)
An Introduction to Drug Safety and Pharmacovigilance (PV03)
Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures (ICT01)
The courses are approved by:
Onorach Ltd is a company registered in Scotland (SC363090). VAT No. GB 108816609
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