”In spite of the very wide-ranging investigations which a drug must undergo prior to approval, in particular rare risks can only be recognized after their market launch in the context of wider use and everyday use. Collecting spontaneous reports is still the best way to detect such problems at an early stage."
PHARMACOVIGILANCE.
Pharmacovigilance is a demanding area with complex legal requirements. We help you to fulfill all requirements.
Our team of trained experts develops with you your tailor-made PV system. Our services include:
- Tailor-made solutions for your pharmacovigilance responsibility
- Providing a temporary staff member for your pharmacovigilance department (e.g. holiday replacement)
- EU-QPPV/deputy function
- Country specific responsible person for pharmacovigilance – Local Safety Officer (LSO)
- Pharmacovigilance quality system set-up and management
- PSMF authoring
- MedDRA coding of AE notifications & preparation of PSURs (PBRERs)
- Case Processing / Adverse Event notifications to authorities via EVWeb
- PSURs / PBRERs
- Eudravigilance (company registration, data entry)
We take over all activities to register your company in the Eudravigilance Database starting from SPOR via EMA Account Management to Eudravigilance
- XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) – data entry
- Signal detection
- Local and global literature review
- Screening of PV relevant webpages
- Risk Management Plans (RMPs)
- Dear Doctor Letter (DHCPC)
- Quality Complaints / Recall Organisation
Reporting of quality complaints and agency contact, recall organisation and agency communication - Safety Data Exchange Agreements
- Pharmacovigilance Audits and vendor qualification
Clinical Trial Safety
- Clinical trial safety officer
- EudraVigilance responsible person for non-EU sponsors
- SAE/SUSAR processing, reporting, submission
- DSURs