25-27 May 2021
Online
Amplexor’s annual BE THE EXPERT conference brings together leading subject matter experts and industry professionals from around the world
For three days, Amplexor’s annual BE THE EXPERT conference brings together leading subject matter experts and industry professionals from around the world into one forum to discuss and exchange strategies that combat the challenges in an everchanging regulatory landscape.
Our conference will be hosted in a virtual event - comprised of live and on-demand sessions.
Daily speaker sessions are structured to address key industry topics:
- Regulatory Information Management
- IDMP
- Labeling Management
- Quality Management
Daily SCHEDULE:
TUESDAY, 25 MAY
14:15 - 14:25 CEST
Virtual Meeting Overview and Intro
Ian Crone, Global Strategic Accounts Consultant, Amplexor
14:30 - 15:15 CEST
Regulatory Impact of COVID-19: Shifting Priorities and Investments to get to RIM 2025
Steve Gens, Managing Partner, Gens & Associates
Most Regulatory Organizations were already in a significant modernization phase when COVID-19 disrupted how daily work was accomplished. This presentation focuses on how regulatory organizations are adjusting their focus and investments in the near and longer term. It is based off of Gens & Associates fall COVID-19 Research and their latest RIM 2025 projections
15:20 - 15:50 CEST
The importance of connected labeling in the times of digitalization
David Gwyn, VP Life Science Solutions, Amplexor
15:55 - 16:25 CEST
How holistic RIM is driving the future of Regulatory Affairs
Agnes Cwienczek, Head of Product Management and Consulting, Amplexor
16:30 - 16:40 CEST
Wrap-Up and Close
Ian Crone, Global Strategic Accounts Consultant, Amplexor
16:45 - 17:30 CEST
RIM Customer Circle - Interactive (by invitation only)
Agnes Cwienczek, Head of Product Management and Consulting, Amplexor
WEDNESDAY,
26 MAY
14:15 - 14:25 CEST
Welcome and introductions
Ian Crone, Global Strategic Accounts Consultant, Amplexor
14:30 - 15:15 CEST
The IDMP roadmap: current EMA needs (based on EU IG v2.0) and longer term telematics. How to make it fit
Frits Stulp, Managing Director, Iperion
15:20 - 16:00 CEST
xEVMPD today & IDMP tomorrow - recent challenges in the industry
Chris Kravogel, Project Coordination Manager, HCI Solutions AG
16:05 - 16:35 CEST
Supporting IDMP implementation through practical cases of AI-based data extraction
Renato Rjavec/Hanno Ebsen, Director of Products / Senior Manager, Amplexor/Averbis
16:40 - 16:50 CEST
Wrap-Up and Close
Ian Crone, Global Strategic Accounts Consultant, Amplexor
16:55 - 17:40 CEST
IDMP Customer Circle - Interactive (by invitation only)
Renato Rjavec, Director of Products, Amplexor
THURSDAY,
27 MAY
14:15 - 14:25 CEST
Welcome and introductions
Ian Crone, Global Strategic Accounts Consultant, Amplexor
14:30 - 15:15 CEST
A holistic data driven approach from R&D to Quality or how I can get rid of documents in the future
Peter Brandstetter, Senior Manager, Accenture
15:20 - 15:50 CEST
"Where is this coming from?" – a holistic view on suppliers
Siniša Belina, Senior Life Sciences Consultant, Amplexor
15:55 - 16:25 CEST
Controlling the domino effect of quality processes
David Gwyn, VP Life Science Solutions, Amplexor
16:30 - 16:40 CEST
Wrap-Up and Close
Ian Crone, Global Strategic Accounts Consultant, Amplexor
16:45 - 17:30 CEST
Quality Customer Circle - Interactive (by invitation only)
Siniša Belina, Senior Life Sciences Consultant, Amplexor
Keynote speaker highlight:
Partner
On-Demand
Sessions
As part of Amplexor’s upcoming BE THE EXPERT 2021 virtual event, we are pleased to announce the following partners who will present a pre-recorded webinar session to address the following:
- Regulatory Information Management
- Labeling Management
- Quality Document Management
All registrants will receive links to the on-demand webinars.