Agenda eRA 2019
Day 1 - 22 May
draft version - subject to change
08:30 Registration and Networking Welcome Coffee
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 Panel
10:00 Validating Artificial Intelligence in Regulatory - Klavs Esbjerg, Epista
- What is Artificial Intelligence and how can it create value in Life Science: Software as (or in) a medical device, AI in a computer system (EDMS, ERP), Research, and more
- How is AI/machine learning related to data?
- Why is it critically important to keep data in control?
- What are the challenges, and solutions, when it comes to staying in control of data?
- What kind of problems do we have when we want to verify the results?
10:30 Networking Coffee Break
A2 Telematics - Back to the Future
11:00 How Today's Telematics Will Shape the Way You Work Tomorrow. (SPOR, Target Operating Model, eAF, CESP and ePI) - Remco Munnik, ASPHALION
- Overview of the Telematics Strategy
- Current status of ongoing programmes
- Impact on the Industry
11:30 How ePI (electronic Product Information) Will Impact Your Regulatory Working – Fakhredin Sayed Tabatabaei, Medicines Evaluation Board Netherlands
- What is ePI: Product Information as a database?
- Downstream: How ePI will improve Patient Safety?
- Upstream: ePI and the facilitation of regulatory working
12:00 The Evolution of CESP – Kevin Horan, Bearing Point
- The birth of CESP
- How CESP impacted the regulatory network
- The Future of CESP
12:15 Simplifying Your Controlled Vocabularies – Gary Wilson, CorrIT
12:30 Networking Buffet Lunch
A3-D3 Barcamps Part 1
14:00 Introduction to the Interactive Sessions - Choose two of your favorite topics
14:10 Submission Management in the Cloud
14:50 Submission Management in the Cloud
Moderated by Alexander Beck and Sven Pallarz, EXTEDO
14:10 Authorities and Industry – achieving mutual goals
14:50 Authorities and Industry – achieving mutual goals
Moderated by Schei Dattner, sales4u, Maren Müller and Michael Gessert, EXTEDO
14:10 Supporting the Collaboration between CRO and the Sponsor
14:50 Supporting the Collaboration between CRO and the Sponsor
Moderated by Kyle Stretch and Jason Grube, EXTEDO
14:10 CIS Session (in Russian)
14:50 CIS Session (in Russian)
Moderated by Inpharmatis
15:30 Networking Coffee Break
16:00 Regulatory Update for the EAEU Region
16:30 Challenges and Best Practices on Asian Submissions - Simon Li, Molecular Science Center, Genetics Generation Advancement Corp.
17:00 Successful Implementation of a Regulatory Information Management System at Kern Pharma - Marta Gascon Moya and Beatriz Domínguez Pérez, Kern Pharma