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 help you meet that requirement.
Benefits of attending:
This course will be relevant for anyone requiring an overview of pharmacovigilance or wishing to consolidate existing knowledge. It
will also benefit those working in pharmacovigilance, as well as those who support or interact with pharmacovigilance from areas including medical information, regulatory affairs, clinical, sales and marketing, legal, commercial and quality.
An introduction to EU pharmacovigilance
Documentation to be supplied to regulatory authorities
Department links in the company to pharmacovigilance
The roles and responsibilities of a licence holder
The role of the Qualified Person for Pharmacovigilance (QPPV)
Standard operating procedures (SOPs) in relation to pharmacovigilance
Graeme Ladds (27 Apr 2020)
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.