EXTEDO's eRA conference 2023

Meet global industry and agency experts at Extedo's eRA conference

Join Epista at eRA 2023, a unique learning and networking opportunity for regulatory, safety and quality professionals from around the globe.

This packed program will offer insights and the latest developments in the global regulatory landscape, with presentations from industry and authority thought leaders. Discover more about how new standards help connect the world and foster collaboration between industries as well as authorities.

Subjects covered will include the latest updates on IDMP, eCTD 4.0, and R3 worldwide, the importance of structured and controlled data to improve patient safety, the transition towards a data-driven world, the latest developments in regulatory information management from an industry and authority perspective, and much more.

As always, attending eRA offers a unique opportunity to network with industry and agency experts, create meaningful connections and work together to improve the life sciences industry for everyone. Epista will be speaking in Break-Out Session 3. Come and listen to our very own Oliver Bosch discuss Central Intelligence & Compliance by Design - Data Integrity and data efficiency. See the rest of the agenda below:

Agenda (subject to change):

Day 1: July 5

• 08:30 - Registration and Networking Welcome Coffee
• 09:00 - Welcome & EXTEDO's transformation
• 09:30 - 2023 and beyond: what's coming and are you ready to face the future?
• 10:00 - A 12-month recap of EU IDMP: Industry and agency feedback on DADI, SPOR, ePI, the initial TOM and their impact on MRP/DCP
• 10:30 - Networking Coffee Break
• 11:00 - SPOR - The importance of structured and controlled data - An overview of the implementation guide, next steps & room for improvement
• 11:30 - Transforming a Life Science organization towards a compliant and robust data-driven quality culture – lessons learned and observations
• 12:00 - Panel Discussion - eCTD 4.0 - how to prepare? Agency vs. Industry
• 12:30 - Networking Buffet Lunch
• 13:30 - Break-Out Sessions (including a Networking Coffee Break at 15:00)
• 16:30 - End of Official Part Day 1
• Evening Event and Dinner

Day 2: July 6

• 08:45 - Opening Day 2 & Recap Day 1
• 09:00 - World Health Organization (WHO) Presentation
• 09:30 - Current and future market trends - Where is Regulatory Information Management headed in the near and longer term?
• 10:00 - How to integrate electronic signatures in a seamless end-to-end document creation & approval process
• 10:30 - Networking Coffee Break
• 11:00 - ePI - product information standard from a European and a global perspective
• 11:30 - Panel Discussion - Transition towards a data-driven world (Recap both days)
• 12:15 - Thank you & Closing
• 12:30 - Networking Buffet Lunch
• 13:30 - User Group Meetings
• 14:30 - Networking Coffee Break
• 15:00 - User Group Meetings
• 16:30 - End of eRA Conference 2023

Learn more and register on Extedo's website!