Agenda eRA 2023
Day 1 - 05 July
Subject to change
Registration and Networking
Welcome & EXTEDO's transformation
Martin Schmid, CEO, EXTEDO
Schei Dattner, VP Sales & PM, EXTEDO
2023 and beyond: what's coming and are you ready to face the future?
Remco Munnik, Director, Iperion (a Deloitte company)
A 12-month recap of EU IDMP: Industry and agency feedback on DADI, SPOR, ePI, the initial TOM and their impact on MRP/DCP
Kristiina Puusaari, European Medicines Agency (EMA)
Networking Coffee Break
SPOR - The importance of structured and controlled data - An overview of the implementation guide, next steps & room for improvement
Beatriz Ugalde Dionicio, Regulatory Data Manager, Asphalion
Transforming a Life Science organization towards a compliant and robust data-driven quality culture – lessons learned and observations
Tore Bergsteiner, Managing Partner, MAIN5
Dominik Gigli, Management Consultant, MAIN5
Panel Discussion - eCTD 4.0 - how to prepare? Agency vs. Industry
Anjana Pindoria-Rettenberger, Director Product Strategy, EXTEDO & Panelists
Networking Buffet Lunch
Break-Out Sessions
Break-Out Session 1
including a Networking Coffee Break at 15:00
Global Overview of eCTD 4.0 - Current Status and Future Expectations - Shakul Hameed, BeiGene
The new superstar on the horizon - Is the pharma world ready for eCTD 4.0? - Anjana Pindoria-Rettenberger, EXTEDO
[Title] - Stan van Belkum, CCMO
Highlights on issues between Industry and Agency by using eCTD submissions across regions - Ana Veronica Mak, Parexel
EXTEDO's Publishing Services Offering - A Case Study at Argenx - Sylvie Colin, EXTEDO
Moderated by Maren Müller, EXTEDO
Break-Out Session 2
including a Networking Coffee Break at 15:00
Navigating through the landscape of the new Clinical Trial Regulations and connections to the R3 standard - Dr. Reinhard Nibler, Dr. Nibler & Partner
Managing PV information in an international Organization
Compliance with Chinese PV requirements - How to implement them? - [Speaker Name], AB Cube
Pharma Market and Regulations in the GCC Region - Dr. Mona Al Moussli, PRA Consultancy
The use of Artificial Intelligence (AI) in Drug Safety - Solution for all your challenges? - Stavros Kardahakis, EXTEDO
Moderated by Andrea Striebel, EXTEDO
Break-Out Session 3
including a Networking Coffee Break at 15:00
Central Intelligence & Compliance by Design - Data Integrity and data efficiency - Oliver Bosch, Epista
Processing a change request with an end-to-end RIM platform solution - A Case Study at Heumann Pharma - Lukas Ebertsch, Heumann Pharma
It's all about automation - Efficient regulatory processes for a shorter time to market - Nicole Sagner, EXTEDO
Regulatory Intelligence - Quickly accessible, always up-to-date regulatory information to speed up daily business - Michael Faust, EXTEDO
EXTEDO Customer Case Study - Helena Catena, Asphalion
Moderated by Anna Thaidigsmann, EXTEDO
Break-Out Session 4
including a Networking Coffee Break at 15:00
EXTEDO's Cloud Services - Bertram Dorn, Amazon Web Services
EXTEDO's Validation Services - Keith Wallace, EXTEDO
Changes in Regulatory Fields in CIS Countries - Dr. Polina Dombure, Inpharmatis Group
Efficient global organization-wide viewing and reviewing of submissions - Big Pharma Customer Case Study
Effective digital transformation of regulated business processes within the CARA platform - Max Kelleher, Generis
Moderated by Dr. Gerhard Neurauter, EXTEDO
End of Official Part Day 1
Evening Event and Dinner
meet in front of hotel for bus shuttle (included in all passes)
Registration and Networking Welcome Coffee
Welcome & EXTEDO's transformation
2023 and beyond: what's coming and are you ready to face the future?
A 12-month recap of EU IDMP: Industry and agency feedback on DADI, SPOR, ePI, the initial TOM and their impact on MRP/DCP