Pharmacovigilance
PV SOPs and other controlled operating instructions
DADA can assist in the preparation and/or review of standard operating procedures (SOPs) and other quality-controlled operating instructions to facilitate the creation of a pharmacovigilance system or the improvement of a pre-existing system. In the tightly regulated world of pharmacovigilance, well-written, up-to-date and comprehensive SOPs and other quality documents are absolutely essential. These will be focused upon during an inspection, and all staff conducting the procedures described within should have documented that they were trained prior to initiating the procedure. DADA has a full suite of SOPs and work instructions describing all the pharmacovigilance activities we conduct on behalf of our clients. Our experienced staff can help you ensure that you have an adequate description of activities in line with current pharmacovigilance legislation.
For more information about this service, please contact: Angela van der Salm PhD – office@dada.nl
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 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
- XEVMPD population and maintenance
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed