Project Manager - FDA Final Rule for Post-marketing Safety Reporting (PMSR) for Combination Products.
Our client is working to implement a process to ensure compliance with the FDA Final Rule for Post- marketing Safety Reporting (PMSR) for Combination Products. A combination product is a product composed of any combination of: drug, biologic or device. The goal of PMSR is to protect the public health by ensuring a combination product’s continued safety and effectiveness once on the market. Instead of having two separate reports for Adverse events and reportable Product Malfunctions, one combined MedWatch form is preferred to be submitted to FDA. The compliance date for the Final Rule is July 19, 2018.
Project Management support is required to ensure timely execution of the implementation plan to meet compliance with FDA Final Rule.
Project Management support is required for the following areas: