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.
What will we discuss in Webinar?
New legislative demands
Qualification and experience of personal responsible for pharmacovigilance
IT management methods (creation and validation)
Pharmacovigilance quality system
Pharmacovigilance system master file preparing
Rational resource and responsibilities assignment
For drug developers, pharmaceutical and biotech companies, participants of the clinical trial market, doctors.
Julia Trakhtenberg, IPHARMA Medical Director
Dmitry Davydov, IPHARMA Medical Advisor , Qualified Person Responsible for Pharmacovigilance