Pharmacovigilance training: should I outsource? And whom?

The laws governing surveillance prescribe 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 main requirements of the pharmaceutical companies, it is important that they create adequate pharmacovigilance the system, which causes a number of problems.

First, regulations are certainly difficult to interpret when it comes to more delicate points.

Second, if it is wrong, it can undergo a surveillance check and the marketing license of a particular the product can eventually be revoked.

Therefore, there is a long way and there are effective solutions for Pharmacovigilance training at hand. As a pharmaceutical company, you have two basic options: make the whole group within the company or outsource part or all of the pharmacovigilance process.

Pharmacovigilance at home:

Pros: Inevitably, wages in the home will be lower than the use of qualified personnel. Employees within the company already know the company's culture and systems and will adapt quickly to operate and work in the pharmacovigilance department. When you have a marketing permit for many products in many areas, it makes sense to have specialized personnel to deal with the safety of medications, since a smaller company may be in a subcontracting mode for the process of waking medications.

Cons: you need specialized personnel in the field of pharmacological precaution. You train, but where and at what price? You will need a validated pharmacovigilance database, not just a spreadsheet in Excel or some websites set up by your child's CEO in Access.

Then there is the training: Pharmacovigilance training in Hyderabad is in drug surveillance. Do you want to train your staff by academics who don't really understand the industry? Or maybe they should be trained by former regulators who never had to work for a pharmaceutical company so that their knowledge was only theoretical? Or maybe I could train them for someone who used to work for a pharmaceutical company that wouldn't have a real idea of ​​what the organizers thought.

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 through the CPD certification service. 

These people are there, but it will be hard to find. When you look at the qualifications of the people who are trained in pharmacological and internal surveillance conferences, these are the types of factors that should influence your decision to attend: do the presenters have the appropriate experience for my office staff to learn and what we need in these courses?

The requirements for EU drug surveillance legislation continues to be discussed on the Pharmacovigilance training in Mumbai Information Service website, with special emphasis on Volume 9 of the EU Medical Products Rules, which contains guidelines for pharmacovigilance of Human and veterinary medicines.