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:
This course will be relevant for anyone requiring an overview of pharmacovigilance or wishing to consolidate existing knowledge. It will be of relevance to those working in pharmacovigilance, as well as those who support or interact with pharmacovigilance eg medical information, regulatory affairs, clinical, sales & marketing, legal, commercial & quality.
09.00 Registration and Coffee
09.30 Meeting starts
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 Pharmacovigilance (QPPV)
Standard Operating Procedures (SOPs) in Relation to Pharmacovigilance
17.00 Meeting ends
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.