Agenda eRA 2019

Day 1 - 22 May

draft version - subject to change

08:30 Registration and Networking Welcome Coffee

A1 Keynotes

09:00 Opening Address and Welcome - We listen to your feedback (Results RIMS Survey, Customer Success Project) - Martin Schmid and Maximilian Munte, Managing Directors, EXTEDO

09:30 Regulatory Agency Update

10:00 Validating Artificial Intelligence in Regulatory - Klavs Esbjerg, Epista

10:30 Networking Coffee Break

11:00 Successful Implementation of Controlled Vocabularies - Gary Wilson, CorrIT

11:30 Target Operating Model (TOM) - Concept, Status and Potential Impact of Implementation - Remco Munnik, ASPHALION

12:00 IDMP Datapilot – An Easy Exercise or a Kind of Magic - Christian Kravogel, EXTEDO

In an European project, a number of NCAs have been working on an IDMP data pilot during 2018 in order to more completely understand the product standards. In parallel, several MAHs have started their own IDMP datapilots to find out if all data required by IDMP iteration 1 is available or not. 

This presentation shows some of the typical pitfalls and challenges and helps you to make your own product data and systems ready for the upcoming IDMP implementation.

12:30 Networking Buffet Lunch

Barcamps Part 1

14:00 Introduction to the Interactive Sessions - Choose two of your favorite topics

Room A

14:10 eCTDmanager in the Cloud

14:50 eCTDmanager in the Cloud

Room B

14:10 Authorities and Industry – achieving mutual goals

14:50 Authorities and Industry – achieving mutual goals

Room C

14:10 Data protection in Pharmacovigilance: Daily challenges and solution possibilities

14:50 Data protection in Pharmacovigilance: Daily challenges and solution possibilities 

Room D

14:10 CIS Sessio(in Russian)

14:50 CIS Sessio(in Russian)

15:30 Networking Coffee Break

16:00 Regulatory Update for the EAEU Region

16:30 Customer Success Story (Asia)

17:00 Customer Success Story (Europe)

17:30 End of Official Part Day 1

18:30 Evening Event (Boat Cruise on Lake Starnberg) and Dinner - meet in front of hotel for bus shuttle (included in all passes)