First of all, the regulations are often hard to interpret certainly when it comes down to the finer points.

The laws governing pharmacovigilance lay down strict instructions on what pharmaceutical companies must do in the event of detecting a serious adverse event, and indeed what constitutes a serious adverse event. With these major demands on pharmaceutical companies, it is important for them to set up an appropriate pharmacovigilance system, and this causes a number of problems.

Second of all, if Pharmacovigilance institute you get it wrong, you can be subject to a pharmacovigilance inspection, and you may eventually have your marketing authorization revoked for a particular product.

So, there is an awful lot riding on having effective pharmacovigilance solutions to hand. As a pharmaceutical company, you basically have two choices: either do the whole lot in-house or outsource some or all of your pharmacovigilance operation.

There are pros and cons to both.

In-House Pharmacovigilance:

Pros – Inevitably, in-house wages will be lower than using qualified staff. In-house staff already know the company culture and systems and will adapt quickly to running and working in a pharmacovigilance department. Where you have marketing authorization for many products in many territories it makes sense to have dedicated staff to deal with drug safety where a smaller company might be better off outsourcing their pharmacovigilance operation.

Cons – You need specialist staff in pharmacovigilance. You can get training, but where and at what cost? You will need a pharmacovigilance database that is validated, not just a spreadsheet in Excel or some Web site the CEOs kid knocked up in Access.

Then there’s the training – pharmacovigilance training. Would you like your staff trained by academics who don’t really understand the industry? Or maybe they should be trained by former regulators who have never had to work in a pharmaceutical company so their knowledge is only theoretical? Or maybe you could have them trained by someone who used to work for a pharmaceutical company who will have no real idea about what the regulators are thinking.

Or possibly you could find someone who has experience of all three arenas who could train your staff, someone accepted as a registered presenter for Continuous Professional Development by the CPD Certification Service. Such people are out there but would be hard to find. When you look at the qualifications of the people doing the training at pharmacovigilance conferences and in-house, these are the sorts of factors that should influence your decision to attend – do the presenters have the right experience so that my staff and I will learn what we need to in these sessions?

Discussion of the requirements of the pharmacovigilance legislation in the European Union is continued on the Pharmacovigilance Information Service’s Web site with particular emphasis on Volume 9 of the rules governing medicinal products in the European Union, which contains pharmacovigilance guidelines for medicinal products for both human and veterinary use. You can see the full text of Volume 9A of the Rules Governing Medicinal Products in the European Union: Pharmacovigilance for medicinal products for human use – at 229 pages it is a little long to paste here.