With the largest change in regulations in the European Union becoming fully effective in July 2015, it is not an understatement to say the Pharmacovigilance environment is changing at an unprecedented pace.
These new regulations work to strengthen transparency and communication and enhance drug safety. However, transitioning to comply with these regulations can be challenging.
Pharmacovigilance System Master File
The Pharmacovigilance System Master File is one of the most critical documents for regulators and is generally the first document that is requested in any EU PV audit or inspection. It is essential to make sure your company’s processes and tools regarding this have been optimized to ensure:
- Greater visibility and reduced risk from outsourced vendors
- Process standardization
- Heightened quality and efficiency
- Reduced administrative burden
Click on the link below to view our webinar and see how implementing a nimble software tool can provide practical solutions and give you peace of mind.