The law governing pharmacovigilance lay down rigid details on what pharmaceutical firms must do in the event of analysing a serious adverse event and indeed what constitutes a serios adverse event. With these major demands on pharmaceutical firms, its essential for them to set up a right pharmacovigilance system and this might cause a various of issues.
First of all, the regulations are usually tough to interpret specifically when it comes down to the finer points.
Second of all, if you get it wrong, you can subject to pharmacovigilance inspection and you might in time have the marketing authorization revoked for a specific product. So, there is a terrible lot riding on having effective solutions to hand on pharmacovigilance. As a pharmaceutical firm, you must have two choice: either do the whole lot in – house or outsource some of the pharmacovigilance operation.
The Benefits And Disadvantages Of Both
Advantages Of In – House Pharmacovigilance
Inevitably, in – house wages will be less than experienced staff. In – house employees already know the firm’s culture and systems and will adapt immediately to running and working in a pharmacovigilance department. Where you have marketing authorization for various products in various territories it makes sense to have experienced and dedicated employees to deal with drug safety where a smaller firm might be better off outsourcing the operation of pharmacovigilance.
Disadvantages Of Pharmacovigilance
You need specialist expert in pharmacovigilance. You can get training, but where and at what cost? You might need a pharmacovigilance database that is validated, not just a spreadsheet in excel or online the CEOs kid knocked up in access.
Then there is training – pharmacovigilance training. If your life the employees trained by academics who don’t really know the industry? Or maybe they must be trained by formed regulators who have never had to work in a form so their knowledge is only theoretical? Or maybe you can have them trained by someone who used to work for the firm who might have no real idea about the regulators are thinking.
Or just you might someone who has experience of all 3 areas who can train your employees, someone accepted as a registered presenter for CPD certification service which means Continuous Professional Development. Such people are out there but not easy to find. When you look at the qualifications of the people performing the training at the conferenced and in – house, these are the kinds of elements that must influence the decision to attend – do the presenters have the right experience so that the employees and you know what you want to in these sessions?
Discussion of the requirements pf the legislation in the European Union is continued on the information service website of pharmacovigilance with specific emphasis on volume 9 of the governing rules medicinal products on the European Union, which has the guidelines for medical products for both veterinary and human use.
There are various firms out there offering these services but very few that have been set up as dedicated contract research firms by some of the people who have been in the field since the start.