5-7 June 2019
Dolce Fregate Provence
Saint-Cyr-sur-Mer, France

AMPLEXOR

WEDNESDAY, 
5 JUNE

Solutions Training Day, What’s New and What’s Coming with AMPLEXOR Life Sciences Suite Solution Offering

13:00 - 13:15

Overview: AMPLEXOR Life Sciences Suite and Compliance Foundation Updates
Renato Rjavec, Director of Product Management

13:15 - 13:40

Integral Management of Development Authorizations in the AMPLEXOR Life Sciences Suite 
Agnes Cwienczek, Senior Life Sciences Consultant and Team Lead

13:40 - 14:05

Enhancements of the End-to-end Marketing Authorization Process in the AMPLEXOR Life Sciences Suite 
Siniša Belina, Senior Life Sciences Consultant

14:05 - 14:30
Networking and Coffee Break
14:30 - 14:55

AMPLEXOR Compliance Foundation: New Hyperlinking, Collaborative Editing and Bulk Workflow Capabilities
Anamarija Doležal, Senior Product Consultant

14:55 - 15:20

How LabelExpert Will Enrich Existing Label Management Capabilities in the AMPLEXOR Life Sciences Suite 
Jelena Milićević, Product Consultant

15:20 - 15:45

Introduction of the New AMPLEXOR Life Sciences Suite Reporting and Analytical Capabilities
Sebastian Ladika, Product Consultant

16:30 - 18:30
Customer Circle Strategy Sessions
Table #1 – Challenges and Pitfalls of Label Management
Table #2  What and How Can Pharmaceutical and Medical Device Industries Learn from One Another?
Table #3  The Holy Grail of Submission Management and Publishing
Table #4  How Can Life Sciences Benefit from Artificial Intelligence Technology?
19:45
Opening and Networking Reception

THURSDAY,
6 JUNE

Solution Pavilion, Solution Academy and ASK AN EXPERT are ongoing Thursday through Friday. 

8:00
Welcome and Introductions
8:30 - 9:15
Keynote - Make Transformation Happen
Ruud Veltenaar - R. Veltenaar and Associates
9:50 - 10:10
Coffee Break
10:10 - 10:45
Digital Transformation: Human Interpretation Inclusion or Exclusion?
Grzegorz Kojro, CDM Senior Specialist - Pfizer
10:45 - 11:20
AI’s Disruptive Transformation Potential for Multilingual Content and Information-centric Life Sciences Processes
Monika Vytiskova, Global Solutions Architect - AMPLEXOR
Julio Bonis, Content Intelligence Senior Engineer - AMPLEXOR
11:20 - 11:40
Coffee Break
11:40 - 12:15
Achieving Transformation Through the Use of Principles of Best Practice: From A Regulatory (RA) and Quality (QA) Perspective
Yvonne Middlefell, RAC, FRAPS, Executive Director - Stellar Regulatory Affairs Consulting
12:15 - 12:50
Robotic Process Automation in Global Regulatory Affairs in LEO Pharma A/S – How to ensure scalable and robust implementation
Christian Lolk Thomsen, Project Manager - LEO Pharma
12:50 - 14:05
Lunch
14:05 - 14:50

Keynote - Transformation - Defining the Right Level of Regulatory Affairs Technical Checks of Regulatory Files
Dr. Michel Mikhail

14:50 - 15:25
Good RIM Capabilities: The Definition for Successful Transformation
Moncef Kafi, Head of Regulatory Compliance - GUERBET
15:25 - 15:45
Coffee Break
15:45 - 16:20
RIM Business Benefit Realization and Organization Transition
Steve Gens, Managing Director - Gens and Associates
16:20 - 16:55
Circular Information Management: End-to-End Regulatory Information Management
Hans van Bruggen, RIM Scientist - eCTDconsultancy and Qdossier
16:55 - 17:30
Structured Content Management - Reduce, Re-Use, Recycle: What Can Life Sciences Learn From Other Industries?
Jan Benedictus, CEO - FONTO XML
Romuald Braun, Vice President of Strategy - AMPLEXOR Life Sciences
19:15
AMPLEXOR Gala

FRIDAY,
7 JUNE

Solution Pavilion, Solution Academy and ASK AN EXPERT are ongoing Thursday through Friday. 

9:00 - 9:45

Keynote - Regulatory Information Management: Evolving Organizational Needs Versus Operational Necessities
Frits Stulp, Managing Director - IPERION

9:45 - 10:20
Patient Centricity and the Value of Transformation
Alexander Tryba, Managing Director - MAIN 5
10:20 - 10:40
Coffee Break
10:40 - 11:15
Labeling Transformation in the Pharmaceutical and Medical Device industry – Connecting the dots
Tara Baer, Sr. Director - PRA Health Solutions
11:15 - 11:50
Transforming Conflict into Opportunity
Orin Solomon, Senior Global Category Manager - Norgine
11:50 - 12:10
Coffee Break
12:10 - 12:45
The Great Regulatory Catch-Up: Lessons from Big Pharma as Medical Device Manufacturers Succumb to New Reporting Rigor
David Gwyn, Global Solutions Architect - AMPLEXOR Life Sciences
12:45 - 13:20
The New EU MDR/IVDR and Combination Devices
Ben Jacoby, PhD, Regulatory Consultant - Sensus Group, Ltd
13:20 - 14:35
Lunch