Pharmacovigilance
SERVICE ▶
Pharmacovigilance
- Risk Management Plan Development
- Periodical Benefit Risk Evaluation Report Development
- Other Pharmacovigilance Activities
The obligation to submit Risk Management Plans continues to expand, and sponsors are increasingly required to submit them with marketing authorization applications.
QVIS prepares Risk Management Plans in accordance with drug authorization and review regulations and ICH E2E through staff qualified as US Certified Safety Officers. Risk Management Plans include the following items.
QVIS prepares Risk Management Plans in accordance with drug authorization and review regulations and ICH E2E through staff qualified as US Certified Safety Officers. Risk Management Plans include the following items.
· Important safety considerations
· Important efficacy considerations
· Pharmacovigilance plan
· Risk minimization measures
· Post-marketing surveillance plan
· Important efficacy considerations
· Pharmacovigilance plan
· Risk minimization measures
· Post-marketing surveillance plan
QVIS also supports revisions when new safety or efficacy information requires updates.
QVIS prepares risk management implementation evaluation reports and benefit-risk evaluation results in accordance with post-marketing safety management standards or ICH E2C.
This work may include vendor selection and management for post-marketing surveillance activities.
This work may include vendor selection and management for post-marketing surveillance activities.
QVIS provides services optimized for increasingly strengthened pharmacovigilance regulations.
· Case Processing
· Medical Review
· Literature Search
· ICSR Case Processing
· Signal Detection
· Aggregate Report Development (DSUR, PSUR, PBRER, etc)
· Reporting to KIDS and/or MFDS
· Pharmacovigilance System Management File Set-up and Management
· Pharmacovigilance SOP Development
· Good Pharmacovigilance Practice Audits
· Raw Data Analysis and Preparation of Product Renewal Reports
· Medical Review
· Literature Search
· ICSR Case Processing
· Signal Detection
· Aggregate Report Development (DSUR, PSUR, PBRER, etc)
· Reporting to KIDS and/or MFDS
· Pharmacovigilance System Management File Set-up and Management
· Pharmacovigilance SOP Development
· Good Pharmacovigilance Practice Audits
· Raw Data Analysis and Preparation of Product Renewal Reports