| All sessions will be lead by Antoinette Azevedo, president & CEO, e-SubmissionsSolutions.com |
| MONDAY, 27 SEPTEMBER 2010 |
| 8:00–9:00 am |
Registration and Continental Breakfast |
| 9:00–9:10 am |
Introduction and Day I Overview |
| 9:10–10:00 am |
What Is an eCTD for the US? |
| 10:00–10:15 am |
Refreshment Break |
| 10:15–11:45 am |
What is an eCTD for Europe and How Does it Differ From US? How is It the Same? |
| 11:45 am–12:45 pm |
Lunch |
| 12:45–2:45 pm |
Issues Regarding the Content of an Electronic Submission |
| 2:45–3:00 pm |
Refreshment Break |
| 3:00–4:45 pm |
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
|
| 4:45–5:00 pm |
Questions & Answers - Review of Day I |
| 5:00 pm |
Adjourn |
|
| TUESDAY, 28 SEPTEMBER 2010 |
| 8:30–9:00 am |
Continental Breakfast |
| 9:00–9:10 am |
Day II Overview |
| 9:10–10:00 am |
Best Practices in Use of MS Word and Adobe Acrobat Professional (hands-on) |
| 10:00–10:15 am |
Refreshment Break |
| 10:15 am–12:00 pm |
Best Practices in Use of MS Word and Adobe Acrobat Professional (hands-on)
(continued) |
| 12:00–1:00 pm |
Lunch |
| 1:00–2:15 pm |
Building the eCTD (demonstration)
- Initial Submission
- Lifecycle Management
- Repurposing eCTD for Another Country
|
| 2:15–2:30 pm |
Refreshment Break |
| 2:30–3:30 pm |
Breakout Session
Conduct an eCTD Readiness Assessment for a Hypothetical Company and Build Your Findings and Recommendations |
| 3:30–4:30 pm |
Present Findings and Recommendations from Breakout Session |
| 4:30–4:45 pm |
Questions & Answers - Review of Day II |
| 4:45 pm |
Adjourn |