15-17 November 2010
Brussels
| Monday, 15 November 2010 |
| 8:30-9:00 |
Registration |
| 9:00-9:15 |
Introduction and Day I Overview |
| 9:15-10:00 |
What is an eCTD for the US? |
| 10:00-10:15 |
Refreshment Break |
| 10:15-11:45 |
What is an eCTD for Europe and how does it differ from US? How is it the same?
Looking at eCTD for European Medicines Agency and Other European Bodies |
| 11:45-12:45 |
Luncheon Provided |
| 12:45-14:45 |
Issues Regarding the Content of an Electronic Submission |
| 14:45-15:00 |
Refreshment Break |
| 15:00-16:45 |
How to Produce Your eCTD
- Conduct eCTD Readiness Assessment
- Review of eCTD Vendors & Implementation Options
- Role of Electronic Document Management in eCTD Authoring
- How to Integrate the eCTD Culture Within Your Company
|
| 16:45-17:00 |
Questions & Answers
Review of Day I
|
| Tuesday, 16 November 2010 |
| 9:00-9:15 |
Day II Overview |
| 9:15-10:00 |
Best Practices in Use of MS Word and Adobe Acrobat Professional (Demonstration) |
| 10:00-10:15 |
Refreshment Break |
| 10:15-12:00 |
Building the eCTD (Demonstration)
- Initial Submission
- Lifecycle Management
- Repurposing eCTD for Another Country
|
| 12:00-13:00 |
Luncheon Provided |
| 13:00-14:00 |
Feature Topics and Hot Tips From Industry |
| 14:00-15:00 |
Labeling Challenges in Europe |
| 15:00-15:15 |
Refreshment Break |
| 15:15-16:15 |
Interactive Breakout Session
Conduct an eCTD Readiness Assessment for a Hypothetical Company and Build Your Findings and Recommendations
|
| 16:15-16:45 |
Present Findings and Recommendations of Breakout Session |
| 16:55-17:00 |
Questions & Answers
Review of Day II
|
| Wednesday, 17 November 2010 |
| 8:30-10:00 |
Put It to Practice: Hands-on Activity, Part I
MS Word and Adobe Acrobat Professional |
| 10:00-10:15 |
Refreshment Break |
| 10:15-12:00 |
Put It to Practice: Hands-on Activity, Part II
Tools for QC’ing the eCTD and Validation |
| 12:00 |
Adjourn |