Pharmacovigilance
Drug safety or pharmacovigilance is an important and growing field in the pharmaceutical industry, which is strongly influenced by Swiss, European and international laws and regulations. According to HMG Art. 59, the authorization holder, manufacturer or distributor of ready-to-use remedies must provide for a PV reporting system. This includes, inter alia, the name of a pharmacovigilance responsible person (CH) / Qualified Person for pharmacovigilance (international). This technically qualified person is responsible for fulfilling the reporting obligation for adverse drug reactions and must have a very good pharmacovigilance knowledge, which the authorities must certify.
Your challenge
The regulation of pharmacovigilance has become considerably more complex. At the same time, the importance of compliance with pharmacovigilance obligations has increased as regulatory inspection and sanctioning risks have also increased. We enable our clients to comply with pharmacovigilance requirements without having to build up additional capacity.
Our pharmacovigilance service
We relieve pharmaceutical companies and provide the following services:
- External pharmacovigilance responsible person / QPPV
- Assessment, evaluation and review of suspected adverse drug reactions (ADRs)
- Evaluation of the existing pharmacovigilance (Pharmacovigilance System Master File with the associated SOPs)
- Medical Literature Monitoring
- Efficient securing of legal requirement
Leave A Comment