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Event info
Date:29 Sep
Time:12:30 - 16:00
Venue:Medicon Valley Alliance, Copenhagen S

DATA WITHOUT BORDERS

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

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Speakers

 250-x-250-Ewoud-Jan-van-Hoogdalem-web  250-x-250-Jo-Hulbert-web  250-x-250-Quigley_Jane-web 250 x 250 David Passov Photo BW tæt

Ewoud-Jan van Hoogdalem
Vice President
Global Scientific Affairs
PRA Health Sciences

Jo Hulbert
Director
Global Regulatory Affairs
PRA Health Sciences

Jane Quigley
Vice President
Medical Informatics
PRA Health Sciences

David Passov
Senior Vice President
Head of Project Management
PRA Health Sciences

Program

12:30

Registration

13:00

Opening Remarks – Welcome and Introduction

13:10

What Data Do You Need?
• Wider perspective – how to stay ahead of competition
• Target product profile – focused drug development plans
• Success rates
• How to fill the gaps and bring the data package into line with key opinion leader (KOL) feedback and regulatory requirements
Ewoud-Jan van Hoogdalem, Vice President, Global Scientific Affairs, PRA Health Sciences

13:40

Regulatory Strategy & Engagement; A Development Essential
• Taking your current data pack global – gap analysis/data assessment, ensuring existing data is compliant with GXPs and regulatory requirements
• Engaging with Regulatory Agencies – understanding the global engagement model and its variations, gaining buy-in from FDA vs EMA vs rest of world and current trends
• Global Marketing Authorizations – global eCTD for submission around the world, what are regulatory agencies looking for and ethnobridging
Jo Hulbert, Director, Global Regulatory Affairs, PRA Health Sciences

14:10

Refreshment Break

14:40

Leverage Real world Data to make better decisions – New insights from PRA Data Lake
• Showcasing the use of real world data to guide drug development.
• In depth analysis of PRA Data Lake and its influence on decision pathways.
Jane Quigley, Vice President, Medical Informatics, PRA Health Sciences

15:10

Flexible, fit-for-purpose operational delivery models
• How to turn drug development vision, regulatory constraints and real-world medical informatics data into successful operational strategies.
David Passov, Senior Vice President, Head of Project Management, PRA Health Sciences

15:45

Closing remarks

16:00

Afternoon/drinks reception

In collaboration with:

PRAHS