Day 1 - 22 May
subject to change
08:30 Registration and Networking Welcome Coffee
09:00 Opening Address and Welcome - Maximilian Munte and Martin Schmid, Managing Directors, EXTEDO
- We Listen to Your Feedback
- Results RIMS Survey
- Customer Success Project
09:30 Regulatory Telematics Panel - Anjana Pindoria, Remco Munnik, Fakhredin Sayed Tabatabaei, Kevin Horan and Gary Wilson
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
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
- Approaching Master Data and Controlled Vocabulary Management
- Choosing the correct implementation style for your organization
- Establish strong data governance and drive data quality.
12:30 Introduction to the Interactive Sessions - Choose two of your favorite Barcamps
12:40 Networking Buffet Lunch
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, EXTEDO and Remco Munnik, ASPHALION
14:10-17:30 Moderated by Inpharmatis
15:30 Networking Coffee Break
16:00 Regulatory Update for the EAEU Region - Konstantin Koshechkin, Scientific Center for Expertise of Medical Application Products, Ministry of Health, Russian Federation
- Regulation of digital submission for marketing approval of medicines in the Eurasian Economic Union
- Legal regulation of the procedures in the Eurasian Economic Union
- Market authorization and medicines assessment rules in Eurasian Economic Union
- Electronic submission of the dossier
- Market authorization Procedure in the Russian Federation
16:30 Challenges and Best Practices on Asian Submissions - Simon Li, Molecular Science Center, Genetics Generation Advancement Corp.
- The regulatory environment in Taiwan, a South East Asia Country
- What is the RA market strategy in Taiwan?
- How Taiwan RA concur the global submission challenges?
17:00 Optimization of Regulatory Data by Implementing RImanager at Kern Pharma - Marta Gascon Moya and Beatriz Domínguez Pérez, Kern Pharma
- The past: Decision for implementation of RIM solution
- The current: Challenges and achievements
- The future: Benefits and road ahead
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)