Overview
This beginner to intermediate level virtual training course will describe contemporary principles, practical approaches, and regulatory expectations for the Pharmacovigilance Quality Management System. The topics will cover organizational structure, responsibilities, processes and resources required for the pharmacovigilance (PV) system and its quality system. The course employs a mixture of informative instructional sessions, real-world case studies, and hands-on interactive exercises where attendees can apply what they learn. Learners will leave the course with an understanding of how elements of the Pharmacovigilance and Quality Management Systems fit together to achieve regulatory compliance.
A working knowledge of drug safety and pharmacovigilance principles is necessary in order to gain maximum benefit from the course.
What participants from the previous virtual QMS course say:
"Highly informative course, detailing every aspect of a well established QMS, in a professional and clear format, delivered by knowledgeable presenters."
Pharmacovigilance Manager, Romania
"Experienced Pharmacovigilance Consultant with a demonstrated history of working in the pharmaceutical industry. A high quality standard in relation to processes and data analysis. Able to act inter- and intradepartmental taken with the focus on teamwork. Acting EU-QPPV. Experienced in case processing, data analysis, EV reporting (ICSRs as well as art57/XEVMPD), compilation of pharmacovigilance system master files (PSMF), initial compilation and maintenance of CCDS and setting up PV systems. EMA and IGJ inspection experience. Eager to transfer knowledge to people in order to make them grow in the field of pharmacovigilance."
Bianca Schrans-Stassen, EU QPPV, Interdos, The Netherlands
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