Service Types

We have designed a multitude of courses on general and specific regulatory & pharmacovigilance topics including:

Analytical Validation
Appeals, Hearings and Representations
Centralised, Decentralised & Mutual Recognition Procedures
Chemistry of the Drug Substance
Clinical Trial Authorisations
Dossier Content, Style & Presentation
EU Pharmaceutical Regulation of Clinical Trials
EU Paediatric Regulation
EU Product Information
Expedited Reporting of Safety Reports in the European Union
Introduction to Pharmacovigilance – For Administrators
Introduction to Pharmacovigilance – For Sales Representatives
Introduction to the Common Technical Document (CTD)
Marketing Authorisation Applications in the EU
Orphan Medicinal Products in the EU
Overviews and Summaries
Pharmacovigilance System Components & Responsibilities
Pharmacovigilance
Pharmacovigilance Inspections
Periodic Safety Update Reports
Project Planning
Reasons for Rejecting a Marketing Authorisation Application
Regulatory Report Writing
Roles and Responsibilities of an EU Qualified Person for Pharmacovigilance
Scientific Advice in the EU

These courses can be delivered via webinar, offsite or onsite at your presises. We are happy to customise our training modules to meet your company's own requirements.

Please contact us on +44 (0)1628 530554 or email training@wainwrightassociates.com to discuss your training requirements.