Cases and

webinars

Webinar “The practical aspects of Pharmacovigilance system implementation”

Since the ICH GCP confirmation for pharmacovigilance system all Sponsors of clinical trials and registration certificate keepers must to organize the pharmacovigilance system. We pool the experience and give the advices for Pharmacovigilance system implementation in your company.

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What will we discuss in Webinar?

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• New legislative demands

• Qualification and experience of personal responsible for pharmacovigilance

• IT management methods (creation and validation)

• Pharmacovigilance quality system

• SOP creation

• Pharmacovigilance system master file preparing

• Rational resource and responsibilities assignment

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For whom?

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For drug developers, pharmaceutical and biotech companies, participants of the clinical trial market, doctors.

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Hosts:

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Julia  Trakhtenberg, IPHARMA Medical Director

Dmitry  Davydov, IPHARMA Medical Advisor , Qualified Person Responsible for Pharmacovigilance