Pharmacovigilance training: Should I outsource? And from?

The laws governing pharmacovigilance provide strict instructions on what pharmaceutical companies should do if a serious adverse event is detected, and in fact, what constitutes a serious adverse event. With these large requirements for pharmaceutical companies, it is important to establish an appropriate system of pharmacovigilance, which causes a number of problems.

First, regulations are certainly often difficult to interpret when it comes to finer points.

Secondly, if you make a mistake, you may be subject to a vigilance screening of medicines, and ultimately, you can revoke the marketing license for a particular product.

Therefore, much more needs to be done to obtain effective solutions for Pharmacovigilance training. As a pharmaceutical company, you have two basic options: doing the entire batch internally, an external part, or all of the pharmacovigilance.

Internal pharmacovigilance:

Pros: Inevitably, internal salaries will be less than the use of qualified staff. Internal employees already know the company's culture and systems and will quickly adapt to work in the pharmacovigilance department. When you have marketing permission for many products in many areas, it makes sense to have specialized staff to deal with the safety of medicines, where a smaller company can outsource the drug vigilance process better.

Cons: You need staff that specializes in pharmacological caution. You get training, but where and at what price? You'll need a drug-validated database, not just a spreadsheet in Excel or a website discovered by the CEO in Access.

Then there is training: pharmacovigilance training. Do you want to train your staff by academics who don't really understand the industry? Or perhaps they should be trained by former regulators who never had to work for a pharmaceutical company, so their knowledge is only theoretical? Or maybe I could get someone who used to work for a pharmaceutical company to train them that would have no real idea of ​​what the organizers were thinking.

Or maybe you can find someone who has experience in all three areas that can train your employees, and someone has accepted as a registered provider of continuing professional development by CPD certification service. These people are there, but they will be difficult to find them. When you look at the qualifications of the people who train at the drug alert conferences and in the company, these are the kinds of factors that should influence your decision to attend: Do the presenters have the right experience so that employees know and know what we need in these sessions?

The requirements for EU drug vigilance legislation continues to be discussed on the website of the Pharmacovigilance Information Service, with particular emphasis on Volume 9 of the EU Drugs Rules, which contain drug awareness guidelines. For medicines for humans and veterinarians.

There are many companies that provide pharmacovigilance services, but very few of them have been established as research institutions for Pharmacovigilance training in Bangalore by some people working in the industry from the beginning. PrimeVigilance was created as a joint venture between Ergomed and CRO and Elliot Brown Consulting, whose managing director was an author of MedDRA, the medical dictionary of regulatory authorities, and is now used worldwide by all regulators and pharmaceutical companies and, more recently, the World Health Organization. Pietrek Associates offers a similar consulting service. The other option is to go with one of the larger CROs like Parexel, but costs with companies like these can be prohibitive.