How to Gain Approval to Conduct Clinical Trials in Europe
An Introduction to ICH Good Clinical Practice
An Introduction to Clinical Trial Preparation and Design
Clinical Trial Monitoring: Site Evaluation and Set-up
Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
An Introduction to Clinical Trials and Drug Development
Good Clinical Practice Inspections and Audits
The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials

Essentials of Monoclonal Antibodies
An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration
Conducting Pharmacokinetic and Pharmacodynamic Studies

An Introduction to ICH Good Clinical Practice
An Introduction to Clinical Trial Preparation and Design
An Introduction to Clinical Trials and Drug Development
Essentials of EU and US Regulatory Affairs for Human Medicinal Products
Essentials of Monoclonal Antibodies
An Introduction to Good Manufacturing Practice for Medicinal Products
An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration
An Introduction to Drug Safety and Pharmacovigilance
An Introduction to Good Quality Control Laboratory Practice
How to Gain Approval to Market a Generic Drug in the USA

Essentials of EU and US Regulatory Affairs for Human Medicinal Products
Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures
An Introduction to Drug Safety and Pharmacovigilance
Signal Detection and Management in Pharmacovigilance
Risk Management Planning for Medicinal Products
Urgent Safety Restrictions
Orphan Drug Designation in the USA and Europe
The European Centralised Procedure (CP)
The Mutual Recognition Procedure (MRP)
The Decentralised Procedure (DCP)
Preparing Submissions in the Common Technical Document (CTD) Format
Electronic Common Technical Document (eCTD)
Variations to Marketing Authorisations in Europe
Registration of Medicinal Products Based on Monoclonal Antibodies
How to Gain Approval to Market a Generic Drug in the USA
The Regulatory Pathway to Approval of Follow-on Biologics (Biosimilars) in the USA
The New Drug Application (NDA) for Marketing Approval in the USA

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