Recommendations from PRAC – Insights and implementation

Welcome to NDA’s free breakfast seminar Wednesday the 21st of November 08:30 – 09:30

All marketing authorization holders (MAH) are responsible for monitoring and implementing PRAC’s recommendations for signal detection, PSUSA procedures, and referrals, to name a few.

Join us to hear Shelley Gandhi, NDA’s Strategic Advisor of Pharmacovigilance & Patient Safety, share her experience and provide her insights into how PRAC works, how recommendations are decided and how these recommendations are expected to be implemented.

About the speaker

With 19 years experience at the MHRA, and her work with the European pharmacovigilance legislation, has provided Shelley Gandhi with an enormous breadth of experience and knowledge within this area. During her career she has focused on the processes that ensure the safety of medicines and related devices.

When: Wednesday 21st November 08:30 – 09:30. Breakfast from 08:00

Where: NDA Regulatory Service AB, Johanneslundsvägen 2, 2tr, 194 61 Upplands Väsby

The breakfast seminar will be an open and interactive workshop with the opportunity to ask questions to Shelley. Specific questions can also be sent in advance to

Please advise if you would like to discuss them openly during the meeting; otherwise you can book meetings to discuss them separately after the seminar.

Registration: RSVP by Wednesday 14th November to

Contact: Denise Strömquist, Client Relations, Nordics, +46 (0)8 590 778 00 or email