PVPlan ProSanos' PVPlan software enables you to create and manage a Pharmacovigilance Plan, in accordance with the EU Risk Management Plan Template (EU-RMP). With PVPlan, you can document identified and potential safety concerns for a product, and track actions, accountable persons, status, and related milestones for characterizing those concerns and identifying additional concerns. The web based platform makes it easy for diverse and/or geographically separate teams to collaborate and share information through the product lifecycle, and to manage the Pharmacovigilance process. PVPlan enables you to document all Safety Concerns for a product, not just signals generated post product launch or by data mining. Management and QP views allow summary Safety Concern visibility.

Benefits:

• Document Safety Concerns and associated actions throughout the product lifecycle, with an easy-to-use, web based platform.
• Develop and maintain a Pharmacovigilance Plan consistent with EMEA Risk Management Plan (EU-RMP) template.
• Share information and manage pharmacovigilance actions among diverse and/or geographically distributed teams.
• Option to integrate the results of quantitative signal detection into the documentation process