Pharmacovigilance in pharmaceutical companies: An overview.

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance.

Effects of ethanol on the development of genetically determined epilepsies in rats.

In the present study, we provide evidences for a differential effect of perinatal alcohol exposure with a direct correlation to the genetic background on the development of seizures. Ethanol (EtOH) is a widely used psychoactive substance that exerts its action by affecting multiple targets in the central nervous system. EtOH is known to interact with almost all identified neurotransmitters although its effects on excitatory and inhibitory amino acid neurotransmissions are considered to be particularly important in the mediation of its behavioural effects.