Pharmacovigilance
We are an experienced and interdisciplinary team. On the basis of good pharmacovigilance practice (GVP) recommendations we provide comprehensive and individual support for all pharmacovigilance matters.
We have the expertise!
Pharmacovigilance tasks
We undertake individual pharmacovigilance tasks:
- Literature research
- Evaluation and on-time communication of adverse-reaction notifications (incl. follow-up)
- Maintenance of your company-specific adverse-reaction database
- Periodic reports (PSURs/PBRERs) and addendum to the clinical overview
- Risk-management plans (RMPs)
- Signal management and continuous safety evaluation
- Extended EudraVigilance product report message/medicinal product dictionary (XEVPRM/XEVMPD)
Pharmacovigilance system
Set-up and optimisation of pharmacovigilance systems:
- Consultation and support during set-up, the further development and review of your pharmacovigilance systems
- Creation and maintenance of your pharmacovigilance system master file (PSMF)
- Creation, review and maintenance of SOPs
- Training staff and sales force
- Conducting system audits (self-inspections)
- Preparation and follow-up of inspections
- Taking on the functions of the responsible person (EU-QPPV, Stufenplanbeauftragter graduated plan officer)
- Advice on EudraVigilance
- Undertaking pharmacovigilance in clinical trials
Information on privacy for pharmacovigilance
Information on how we process your personal data according to Article 13 of the GDPR can be found in the information centre under data protection.
Karlheinz Gutzler
Vigilance & Quality Services
Phone: +49 7272 7767-2525
Email: k.gutzler@hwi-group.de
Contact us. We’re happy to help!
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