Human medicines
SERVICES
Human medicines
The development of the new pharmacovigilance legislation, which was the biggest change to the regulation of human medicines in the European Union (EU) since 1995, was based on the observation that adverse drug reactions (ADRs), ‘noxious and unintended’ responses to a medicine, caused around 197,000 deaths per year in the EU.
OUR SERVICES
- Help in achieving compliance with the guidelines on Good Pharmacovigilance Practices (GVP)
- Services of a QPPV (24/7) with access to medical adviser
- Establishment and maintenance of the Pharmacovigilance system and Pharmacovigilance system master file (PSMF), including Quality System
- Management of Critical pharmacovigilance processes and business continuity
- Management and reporting of adverse reactions to medicinal products
- Weekly monitoring of scientific literature
- Ongoing benefit-risk evaluation
- Preparation of Risk Management Plan and Risk minimisation measures
- Medical writing (PSUR, RMP, etc.)
- Signal detection and evaluation
- Managing PASS, PAES
- Regulatory actions (safety variations, communications with stakeholders, etc.)
- Electronic transmission of the pharmacovigilance data (Article 57), selection of appropriate tool and implementation of a quality system
- Training of personnel
- Setting up appropriate contractual arrangements and supervision
- Audit and pre-inspection consultations
For medical consultancy you need a lot of experience.
BILLEV PHARMA EAST
Do you have a question for us? Contact us and we will be happy to advise you and find the best solution for you together with you!
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Billev farmacija vzhod d.o.o.
Billev Pharma East Ltd.
2023 BILLEV PHARMA EAST
© 2023 |
Operation title: BILLEV FARMACIJA VZHOD digitalizacija
Link to the European Cohesion Policy website: www.eu-skladi.si
“The investment is co-funded by the Republic of Slovenia and the European Union from the European Regional Development Fund”. – Read more
Operation title: BILLEV FARMACIJA VZHOD digitalizacija Link to the European Cohesion Policy website: www.eu-skladi.si
“The investment is co-funded by the Republic of Slovenia and the European Union from the European Regional Development Fund.” – Read more
