| WEDNESDAY, 29 SEPTEMBER 2010 |
| 8:00 am |
Registration and Continental Breakfast |
| 9:00 am |
eCTD Overview & FDA Requirements
Antoinette Azevedo, president & CEO, e-SubmissionsSolutions.com |
| 10:00 am |
Refreshment Break |
| 10:15 am |
Quality (CMC) Content Overview
- Module 2-3 Quality Overall Summary
- Module 3 Drug Substance, Drug Product, Regional Information, Appendices
- Featuring a simulative, interactive group exercise to evaluate understanding of CMC
Deanna Murden, president, ePharmaCMC, LLC |
| 12:00 pm |
Lunch |
| 1:00 pm |
Safety (Nonclinical) Overview
- Module 2-4 Nonclinical Overview
- Module 2-6 Nonclinical Written and Tabulated Summaries
- Module 4 Safety Study Reports and Datasets
Antoinette Azevedo, president & CEO, e-SubmissionsSolutions.com |
| 2:00 pm |
Efficacy (Clinical) Content Overview
- Module 2-5 Clinical Overview
- Module 2-7 Clinical Summary
- Module 5-2 Tabular Listing of Clinical Studies
- Module 5 Clinical Study Reports, Case Report Forms, Datasets
Emily Onkka, Director, Regulatory Operations and Submissions, Cadence Pharmaceuticals, Inc. |
| 3:00 pm |
Refreshment Break |
| 3:15 pm |
Efficacy (Clinical) Content Overview, continued
Module 5 Case Report Forms & Datasets
Emily Onkka, director, regulatory operations and submissions, Cadence Pharmaceuticals, Inc. |
| 4:15 pm |
Regulated Product Submission (RPS) & eCTD Next Major Version (NMV)
Jason Rock, president & CTO, GlobalSubmit, Inc.
Hans van Bruggen, MSc, senior regulatory affairs consultant and director, eCTDconsultancy BV and Director, Qdossier BV
|
| 5:15 pm |
Review of Day 1 - Q&A and Discussion |
| 5:30 pm |
Adjourn |
|
| THURSDAY, 30 SEPTEMBER 2010 |
| 8:00 am |
Continental Breakfast |
| 8:30 am |
Hands-on eCTD Compilation
Lead Trainer: Warren Perry, director of eregulatory strategies, EXTEDO Inc.
Facilitator: Antoinette Azevedo, president & CEO, e-SubmissionsSolutions.com
|
| 10:00 am |
Refreshment Break |
| 10:15 am |
Hands-on eCTD Compilation
(continued) |
| 11:45 am |
Lunch |
| 12:45 pm |
Hands-on eCTD Compilation
(continued) |
| 3:00 pm |
Refreshment Break |
| 3:15 pm |
FDA eCTD Validation Specifications: How to Assure Your eCTD is Accepted for Review
Jason Rock, president & CTO, GlobalSubmit, Inc.
Antoinette Azevedo, president & CEO, e-SubmissionsSolutions.com
|
| 4:45 pm |
Review of Day 2 - Q&A and Discussion
|
| 5:00 pm |
Adjourn |
|
| FRIDAY, 1 OCTOBER 2010 |
| 7:30 am |
Continental Breakfast |
| 8:00 am |
eCTD Requirements for Europe
Hans van Bruggen, MSc, senior regulatory affairs consultant and director, eCTDconsultancy BV and Director, Qdossier BV |
| 10:00 am |
Refreshment Break |
| 10:15 am |
eCTD Requirements for Canada TPP
Ted Hanebach, director, regulatory standards, i3 CanReg |
| 11:15 am |
eCTD Requirements for Japan
Harv Martens, vice president, operations for North American & Japan, Extedo, Inc. |
| 12:15 pm |
Conclusion
|
| 12:30 pm |
Adjourn
|