Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group, has been invited by Drug Safety Research Unit (DSUR) to chair the course ‘Global Pharmacovigilance Regulatory Requirements: What’s New?’ in London 31 May – 1 June.
In our global pharmacovigilance market the legislation requires the Marketing Authorisation Holder (MAH) of medicinal products to have a pharmacovigilance system where all aspects comply with the requirements of the appropriate regulatory authority. As more MAHs work globally it is increasingly important that they understand local differences in requirements for compliance around the world including inspection procedures and legal implications.
This course brings together a panel of international experts from industry, regulatory and legal backgrounds to provide up-to-date information on all aspects of compliance in pharmacovigilance (both pre-marketing and post-marketing) for Europe, the USA, Latin America, Russia, Africa and Japan including inspection and legal implications.
Click here to find out more about the event.
Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group