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 on pharmaceutical companies, it is important to establish an appropriate system of pharmacovigilance, which causes a number of problems.

First of all, regulations are often difficult to interpret for sure 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, there are a large number of practical pharmacovigilance training solutions at hand. As a pharmaceutical company, you have two basic options: doing the entire batch internally, an external part, or all of the pharmacovigilance.

Pharmacovigilance training:

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 database for pharmacovigilance, not just a spreadsheet in Excel or on a website called CEO 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 it will be difficult to find them. When you look at the qualifications of the people who train at the vigilance 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 and team members know what we need in these sessions?

The requirements for Pharmacovigilance training in Hyderabad legislation continue 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. Use. See the full text of Volume 9A of the EU Drugs Rules: