Pharmacovigilance
XEVMPD population and maintenance
DADA is capable of processing the regulatory information contained in the Summary of Product Characteristics and submitting this information to the extended EudraVigilance Medicinal Product Dictionary (XEVMPD) in line with Article 57(2) of the new pharmacovigilance legislation. The experienced team at DADA will conduct several quality checks during the creation of product report messages (XEVPRM) for submission to the XEVMPD and keep you informed of successful population. Maintenance of the XEVMPD will require close and clear communication to ensure timely updating of the submitted information, a trademark of the DADA team.
Services
Other services in Pharmacovigilance
- Audits
- Communication with National Competent Authorities
- EU Qualified Person for Pharmacovigilance (QPPV)
- Expedited reporting
- Global and local literature screening and review
- ICSR/SUSAR processing
- Inspection readiness
- Local (QP)PV support and AE/MI/PQC processing
- Organisation set-up and changes
- Periodic safety reporting
- Post-Authorisation Safety Studies (PASS)
- PV SOPs and other controlled operating instructions
- PV System Master File (PSMF)
- Risk Management Plans (RMPs)
- Safety Data Exchange Agreements (SDEAs)
- Signal detection and evaluation – benefit/risk assessment in safety review meetings
- Training in pharmacovigilance
- Veterinary PV support
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed