NAVIGATING THE REGULATORY PATHWAY TO GLOBAL MARKETING SUCCESS
PRA Health Sciences brings smart insight into designing and operationalizing a drug development program for cross-border data acceptability within Europe and beyond.
This interactive workshop will examine today’s increasingly complex regulatory and operational landscape, providing clarity and guidance to ensure compliance, and streamline study progression. We will explore proven methodologies on engaging with regulatory bodies, best-practices to help shape a comprehensive data package, and demonstrate how an in-depth analysis of available data can influence decision pathways and operational strategy for global eCTD submission.
Experts from PRA Health Sciences’ therapeutic, operational, data analytics and regulatory groups will be on hand to share the keys to success.
Date: 29 September 2016
Time: 12:30 – 16:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Ground floor
Registration fee: FREE
Speakers
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Ewoud-Jan van Hoogdalem |
Jo Hulbert |
Jane Quigley |
David Passov |
Program
12:30 |
Registration |
13:00 |
Opening Remarks – Welcome and Introduction |
13:10 |
What Data Do You Need? |
13:40 |
Regulatory Strategy & Engagement; A Development Essential |
14:10 |
Refreshment Break |
14:40 |
Leverage Real world Data to make better decisions – New insights from PRA Data Lake |
15:10 |
Flexible, fit-for-purpose operational delivery models |
15:45 |
Closing remarks |
16:00 |
Afternoon/drinks reception |
In collaboration with: