Investigational products - PowerPoint PPT Presentation

Serious Adverse Event Reporting

Serious Adverse Event Reporting. Start-up Meeting March 25, 2010 Kingston, ON. Procedures. Using Pfizer Products MUST follow Pfizer SAE reporting policies. SAEs Defined. Any untoward medical occurrence that at any dose results in: Death Is life-threatening

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Presentation of BE data in a product dossier

Presentation of BE data in a product dossier. Drs. Jan Welink. Training workshop: Training of BE assessors, Kiev, October 2009. Data in a bioequivalence dossier. Data in a bioequivalence dossier. Ethics:. Independent Ethics committee Ethical conduct of study Subject information and consent.

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324 views • 13 slides

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