New Regulatory & Pharmacovigilance training webinars available
pharmafile | March 15, 2011 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing |
Wainwright Associates 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 premises. 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.






