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Pharmacovigilance means oversight of registered and marketed medicinal products in order to ensure maximum safety for patients who take such medicinal products.
Pharmaceutical companies develop, register and sell medicinal products, medical devices and vaccines. They all have a legal obligation to collect and evaluate any information concerning treatment safety, i.e. in particular concerning any suspected adverse effect and any complaints about the quality of their medicinal products.
For these purposes, pharmaceutical companies must set up internal work procedures and have a training plan requiring, among other things, regular annual pharmacovigilance training of their employees. These obligations concern all areas of their activity, including contracting activities such as e.g. market research. This is why, not only the employees of pharmaceutical firms but also all their contracting partners that take part in market research must undergo regular pharmacovigilance training.
The purpose of the AIFP’s project was to adopt a standardized approach to the pharmacovigilance obligations of pharmaceutical companies in conducting market research and training the employees of agencies conducting market research and to develop the pharmacovigilance cooperation of innovative pharmaceutical companies with agencies in order to protect patients and to save time and funds.
An indisputable advantage of the AIFP’s pharmacovigilance training is also the fact that its content has been approved by the State Institute for Drug Control (SIDC) and its completion shall be accepted in case of any potential inspection of pharmacovigilance systems.