Importance of a PVA A Pharmacovigilance Agreement’s importance boils down to the shared activities between two or more parties, which is defined in this legal document between the Marketing Authorization Holder (MAH) and a third party. The purpose of the agreement is for the MAH to access all the relevant information relating to PV activities
Key take-aways from our June Webinar on modernizing your PVAs. Insights from presenters Katherine Long and Kevin Fetterman on streamlining your PV Agreement process from versioning through implementation with total oversight throughout. A robust Pharmacovigilance Agreement can protect both sides of a business partnership from uncertainty, communication gaps, and compliance risks. In fact, the GVP
At a roundtable we recently facilitated on the topic of managing PV partners and associated agreements, we discussed with industry experts the best practices and lessons learned. This topic was fresh on all of our minds, particularly in a year where remote coordination was mission critical. Managing Decentralized PV Organizations The first area of focus
The successful handling of PVA obligations is a critical but often overlooked consideration.
Most Pharma companies rely on passive tools—such as spreadsheets and email—for tracking and managing their Risk Management Plans (RMPs) and Additional Risk Minimization Measures (ARMMs). However, passive tools are inefficient. So, what can Pharma companies do to scale? The answer is: utilize modern technology strategies for managing these processes. However, the first decision they should
