Become a member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Not a Member?

Create Account and Join

Mercure Paris La Défense Grande Arche

Nov 13, 2017 8:00 AM - Nov 14, 2017 4:30 PM

17/20 Esplanade Ch. de Gaulle - Rue des Trois Fontanot, 92000 Nanterre (Paris region), France

Advanced Workshop: QPPV Tool Box – Your Key to Success

ONLY 2 SEATS LEFT! The workshop will allow you to be more efficient in solving the problems in your daily business, and learn the right thinking processes to land at good results.

Back to Agenda

SESSION 4: POST-AUTHORISATION SAFETY STUDIES AND COMMITMENTS AS PART OF THE LIFECYCLE REQUIRING AND INTERFACE WITH CLINICAL TEAMS

Session Chair(s)

Shelley Gandhi, MSc

Strategic Advisor, Pharmacovigilance and Drug Safety

NDA Group, United Kingdom

This session will discuss how the QPPV can to assure and demonstrate oversight of PASS processes in accordance with regulatory requirements with production of PASS reports of adequate quality and completeness in a timely manner. The QPPV needs to be aware of post-authorisation clinical trials, non-interventional studies and future development plans for the product.

Speaker(s)

POST-AUTHORISATION SAFETY STUDIES AND COMMITMENTS AS PART OF THE LIFECYCLE REQUIRING AND INTERFACE WITH CLINICAL TEAMS

Shelley Gandhi, MSc

NDA Group, United Kingdom

Strategic Advisor, Pharmacovigilance and Drug Safety

Have an account?

Advanced Workshop: QPPV Tool Box – Your Key to Success

SESSION 4: POST-AUTHORISATION SAFETY STUDIES AND COMMITMENTS AS PART OF THE LIFECYCLE REQUIRING AND INTERFACE WITH CLINICAL TEAMS

Session Chair(s)

Shelley Gandhi, MSc

Speaker(s)

POST-AUTHORISATION SAFETY STUDIES AND COMMITMENTS AS PART OF THE LIFECYCLE REQUIRING AND INTERFACE WITH CLINICAL TEAMS

Be informed and stay engaged.