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Mercure Paris La Défense Grande Arche

Apr 19, 2016 8:00 AM - Apr 20, 2016 4:30 PM

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

The Regulatory Framework in Europe

Master the Regulatory Affairs essentials.

SESSION 5: VARIATIONS / POST APPROVAL CHANGES

Session Chair(s)

Katarina  Jelic Maiboe, PhD

Katarina Jelic Maiboe, PhD

Denmark

  • Definition of variations
  • Classification of a variation
  • Procedural guidance
  • Renewals

Speaker(s)

Katarina  Jelic Maiboe, PhD

VARIATIONS / POST APPROVAL CHANGES

Katarina Jelic Maiboe, PhD

Denmark

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