E3: xEVMPD Maintenance with Donika Doda

We have the right people on board, we have defined project objectives and a project plan, and we can start the project. Or can we? The Life Sciences Industry has to follow the same regulations, but companies meet that goal differently. Inside the company there can be a gap between the needs of IT and Business. We need to put them on the same journey and work towards the common goal. Anne Pouzet, Senior Consultant, discusses common challenges that companies face when running transformation projects, and shares practical ideas on how to make those projects successful.

In a world where technology is evolving rapidly, and the volume of data that has to be managed is expanding exponentially, how do you maximize what it has to offer? Paul Attridge, VP Regulatory Strategy, shares insights on how people, processes, and data are influencing and impacting the business transformation.

Head of RA Systems and Analytics Helen Donnelly shares her insights into the use of leading and lagging metrics and KPIs, how they are different, and how they can be used to course-correct efforts before it’s too late.

In this episode, Donika Doda, a Regulatory Affairs Specialist with expertise in xEVMPD, discusses strategies and complexities that companies face when trying to make appropriate data submissions to the European Medicines Agency.

Ricard Andreu Saumell, an experienced Regulatory Affairs Officer,  explains the three steps he takes when changes or variations occur, the  importance of alignment across a company, and how a centralised software  solution can help.

Racha Wardeh, a Quality Compliance & Project Manager, graciously joins the podcast to talk about one of her favorite topics: Change Management in the pharmaceutical industry and how to avoid silos that may slow down these processes unnecessarily.