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Pharmacovigilance has become one of the most demanding aspects to both understand and comply with. There are many requirements and duties for companies to perform regarding the safety of their products to satisfy regulatory demands, and sanctions for non-compliance can be severe. This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements. EU pharmacovigilance legislation requires companies to train all staff, including those not working directly in pharmacovigilance and this course will meet that requirement.
Key topics to be covered:
Gain an overview of EU pharmacovigilance
Understand the documentation required to be supplied to regulatory authorities
Clarify the roles and responsibilities of a licence holder
Understand the role of the Qualified Person for Pharmacovigilanc (QPPV)
What are the Standard Operating Procedures (SOPs) in relation to pharmacovigilance
