Delving into the Latest Updates on Mylan Laboratories SAS with Synapse

Overview

A review.The 2017 PAC iAM Survey confirmed many of the perceptions and anecdotal experience within industry and regulatory authorities about the complexity of PAC management.Data from the survey confirms that many organizations deal with long change approval timelines, multiple item versions, or variants of products to manage and multiple global regulatory submissions.This complexity has the unintended consequence of creating drug shortage and supply issues, compliance issues, and more importantly resulting in organizations foregoing innovation and process improvements.The data supports the ongoing efforts from both regulators and industry to ease postapproval regulatory complexity, accelerate innovation, and ensure sustainable supply of quality medicines to patients.It is noted that the use of PACMPs or comparability protocols in the United States (US) and European Union (EU) markets provides some level of relief from PAC complexity; however, as these approaches are not accepted globally, the overall burdensome situation remains unchanged, and the barriers to continual improvement, innovation, and technol. advances remain high and insurmountable in many cases.Steps towards global convergence of regulatory requirements and leveraging addnl. mechanisms such as the companies' pharmaceutical quality system (PQS) for change management are needed to ensure our industry continues to move forward and provide sustainable supply of product to patients.

100 Deals associated with Mylan Laboratories SAS

Login to view more data

100 Translational Medicine associated with Mylan Laboratories SAS

Login to view more data