The 4th PDA Europe Annual Meeting will open with an overview of some of the latest regulatory developments.

Former UK MHRA regulator Andrew Hopkins and Irish Health Products Regulatory Agency representative Anne Hayes will offer their insights. Hayes will focus her talk primarily on PIC/S. Additional speakers from EMA and WHO have been invited.

During the first set of breakout sessions, one session will explore how to manage regulatory requirements.

The Quality Systems Interest Group will convene one day prior the meeting on June24. Big data will serve as the keynote presentation for this interest group meeting.

Other presentations during the interest group meeting will cover quality management systems (QMS), integrating quality risk management (QRM) into a QMS and best practices for conducting management reviews. Group discussions will be led, focusing on management reviews, metrics, QRM, knowledge management and more! Interest group leader Lothar Hartmann, PhD, Managing Director, PhACT GmbH, will moderate the presentations and facilitate discussion.