Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group, has been invited by the Drug safety Research Unit (DSRU) to chair the “Global Pharmacovigilance Regulatory Requirements: What’s New?” course, in London on 6-7 June.
Bridget King, Senior Consultant, NDA Group, will also be presenting on “Global considerations for periodic reports, benefit risk management and risk minimisation and the lifecycle implications” on Wednesday 6th June at 14:00 – 14:45.
In the 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.
The 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 Asia including inspection and legal implications.
This course is aimed at:
- Pharmaceutical industry personnel from areas including drug safety, clinical research, medical affairs, medical writing, regulatory affairs and medical information
- Staff from regulatory authorities
Click here to find out more about the event.