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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.

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SESSION 6: INTERFACE WITH REGULATORY AFFAIRS: LABELLING, VARIATIONS AND RESPONDING TO SAFETY REQUESTS

Session Chair(s)

Shelley Gandhi, MSc

Strategic Advisor, Pharmacovigilance and Drug Safety

NDA Group, United Kingdom

This session will discuss best team-working practices to ensure QPPV involvement in labelling decisions, CCSI creation and maintenance and their implementation through SPC variations and awareness of regulatory safety queries with input where necessary.

Speaker(s)

INTERFACE WITH REGULATORY AFFAIRS: LABELLING, VARIATIONS AND RESPONDING TO SAFETY REQUESTS

Shelley Gandhi, MSc

NDA Group, United Kingdom

Strategic Advisor, Pharmacovigilance and Drug Safety

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Advanced Workshop: QPPV Tool Box – Your Key to Success

SESSION 6: INTERFACE WITH REGULATORY AFFAIRS: LABELLING, VARIATIONS AND RESPONDING TO SAFETY REQUESTS

Session Chair(s)

Shelley Gandhi, MSc

Speaker(s)

INTERFACE WITH REGULATORY AFFAIRS: LABELLING, VARIATIONS AND RESPONDING TO SAFETY REQUESTS

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