Pharmacovigilance has become one of the most demanding aspects to both understand and comply with. There are many requirements 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.
WHY YOU SHOULD ATTEND
The new Pharmacovigilance Legislation requires companies to train all staff, including those not working directly with Pharmacovigilance and this course will meet that requirement.
TOPICS TO BE COVERED INCLUDE:-
- An Introduction to EU Pharmcovigilance
- Documentation to be supplied to Regulatory Authorities
- Department links in the company to Pharmacovigilance
- Licensing partners and Pharmacovigilance
- The role of the Qualified Person for Pharmacovigilance
- Standard Operating Procedures (SOPs) in Relation to Pharmcovigilance
WHO SHOULD ATTEND
This course will be relevant for anyone requiring an overview of Pharmacovigilance. It may be of particular interest to those new to Pharmacovigilance or in a support staff role. It will also be relevant to anyone who works with Pharmacovigilance – eg Regulatory Affairs, Clinical, Sales & Marketing, Legal, Commercial and Quality.