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| Tuesday, April 15, 2008 (Optional Working Group sessions)* |
| 12:00 - 1:00 | Lunch |
| 1:00 - 2:30 | Master and Local Update Working Group |
| 2:30 - 3:00 | Break |
| 3:00 - 4:00 | Reports/Ad-hoc Query Working Group |
| 6:00 - 7:00 | Welcome Reception |
| * open to all attendees at no additional cost |
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| Wednesday, April 16 |
| 8:00 - 9:00 | Breakfast
Aris Global information / registration desk open |
| 9:00 - 9:15 | Welcome and Introductions
Tamir Sigal, Product Marketing Manager (Regulatory) |
| 9:15 - 10:00 | Strategy/Roadmap: Past, Present, and Future of Register
Tamir Sigal, Product Marketing Manager (Regulatory)
What is the current status of the Register application and what is the future of the Register application? This session will review the vision and future direction of Register. |
| 10:00 - 10:45 | Planning Module: What's the Hype? (Part I)
Wim Cypers, Vice President, Product Management
Register 5 includes an integrated product planning component that automates the tracking of registrations against global and local project plans. The new planning module addresses the challenge that many organizations face for managing the numerous activities and resources associated with global regulatory submissions. |
| 10:45 - 11:00 | Break |
| 11:00 - 12:00 | Planning Module: What's the Hype? (Part II - Demo)
Wim Cypers, Vice President, Product Management |
| 12:00 - 1:15 | Lunch |
| 1:15 - 2:00 | Customer Support at Aris Global
Diane Pepe, Senior Director of Customer Support
Customer service is our number one priority. Diane will cover the latest and greatest at Aris Global's support organization. |
| 2:05 - 3:00 | EVMPD Initiative
Simon Sparkes, Vice President, Corporate Strategy and Marketing and Theo Uijtdewilligen, Application Manager Demeter, Global Regulatory Operations, Organon
The EVMPD has been developed by the EMEA in collaboration with the EudraVigilance Implementation forums. The main objective of the EVMPD is to assist the pharmacovigilance activities in the European Economic Area (EEA). As such, the EVMPD has been designed to support the collection, reporting, coding and evaluation of authorized and investigational medicinal product data in a standardized and structured way. This session will provide an update on the initiative. |
| 3:00 - 3:15 | Break |
| 3:15 - 4:30 | Group Discussion - Improvements to the Register Application
Tamir Sigal, Product Marketing Manager (Regulatory)
Do you have enhancements and improvements you would like to make to Register? This will be a group discussion on a number of ideas to advance the Register application and provide direct input into future releases. A session not to be missed... |
| 6:30 - 9.00 | Group Dinner |
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| Thursday, April 17 |
| 8:00 - 9:00 | Breakfast |
| 9:00 - 09:45 | SPL/PIM Update and Discussion
Michel Vulpe, Founder and CTO i4i and Greg Heater, Business Development
A veteran in the field of regulatory standards and the application of mark-up technology, Mr. Vulpe has authored both standards and patents in this field. Most recently, following a lead role in the emergence of the SPL standard, he and his team have been working closely with the FDA in the area of drug registration and listing in preparation for the upcoming Release 4 (R4).
This session will put the current SPL and PIM initiatives in context, looking back at the history of the application of mark-up technology to the objectives of regulators, looking forward to what is next on the horizon, and, beyond the regulatory requirement, looking at how industry can leverage these standards to address the critical issue of inconsistency in labeling content. |
| 9:45 - 10.30 | SPL/PIM open discussion
Discussion led by Greg Heater, Business Development, i4i |
| 10:30 - 11:00 | Break (hotel check out) |
| 11:00 - 11:30 | Novo Nordisk Presentation
Eva Wulff Sørensen, Project Manager, Regulatory Affairs Strategic Management Support, Novo Nordisk
This presentation will provide the audience with an overview of the Register implementation at Novo Nordisk. |
| 11:30 - 12:30 | Regulatory and Manufacturing: Discussion and Update
Tamir Sigal, Product Marketing Manager (Regulatory)
There is a compliance gap between regulatory and manufacturing. This session will discuss the gap, and will provide an update on the integration between Register and SAP. |
| 12:30 - 1:30 | Lunch |
| 1:30 - 3:45 | User Interface, Configuration Tool, and Common Modules
Group Discussion: Wim Cypers, Vice President, Product Management; Simon Sparkes, Vice President, Corporate Strategy and Marketing; Tamir Sigal, Product Marketing Manager (Regulatory)
There will be a brief break at 2:45pm
A session not to be missed. This session will cover the specific user interface enhancements scheduled for Register and show a prototype of the new "Communications" module. This session will also discuss the configuration tool scheduled for Register. |
| 3:45 - 4:00 | Closing Remarks
Tamir Sigal, Product Marketing Manager (Regulatory) |
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