Confidence Beyond Compliance
The marketing authorization applicant/ holder shall have the necessary means to fulfil the tasks and responsibilities listed in EU Directive 2001/83/EC as amended by EU Directive 2010/84/EU.
If required, PharmaLex can take on the tasks and responsibilities of the EU Qualified Person Responsible for Pharmacovigilance, or provide a deputy in times of absence or illness. Key tasks of the EU-QPPV comprises:
- Ongoing monitoring of the benefit and risks of medicinal products.
- Maintenance of the Pharmacovigilance System Master File.
- Serving as point of contact to Regulatory Authorities with 24 hours availability.
PharmaLex can also support clients with the nomination of Pharmacovigilance contact person at national level, responsible for the maintenance of the local Pharmacovigilance System, and based on the EU Member States requirements
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Related Services
- Clinical Trial Applications
- Clinical Trial Safety Support
- Commercialization Readiness
- Global Procedure Management
- ICSR (Individual Safety Case Report) Management
- Interim / Contract QA
- Literature Monitoring & Screening
- MAA / NDA Submissions
- Market Access
- Marketing and Labeling Activities
- MedTech Services
- Pharmacovigilance Consulting
- Pharmacovigilance Systems
- SMARTPHLEX
- SMARTVIGICONTRACT
- SMARTVIGILIT
- SMARTVIGISCREEN
What our clients say
Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!
Head of Ethics and Compliance, Astellas Pharma Europe
There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.
VP Regulatory Strategy