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Global Events

Four Points By Sheraton Bur Dubai

Dec 12, 2016 8:00 AM - Dec 13, 2016 5:30 PM

Khalid Bin Walid Street, Bur Dubai P.O. Box 33196, Dubai, United Arab Emirates

Building the eCTD - Practical Solutions to Compiling Electronic Submissions

This course offers insight into the compilation of the eCTDs, experience and best practice gained during eCTD submissions and explains the eCTD review und lifecycle process.

Agenda

Day 1 Dec 12, 2016

8:00 AM — 9:00 AM

REGISTRATION

9:00 AM — 9:15 AM

INTRODUCTION, LOGISTICS AND OVERVIEW OF LEARNING OBJECTIVES

9:15 AM — 10:45 AM

SESSION 1: INTRODUCTION TO ICH, CTD AND eCTD

10:45 AM — 11:15 AM

COFFEE BREAK

11:15 AM — 12:45 PM

SESSION 2: eCTD GENERATION AND SUBMISSION - BASICS

12:45 PM — 2:00 PM

LUNCH

2:00 PM — 3:30 PM

SESSION 3: SUBMISSION STANDARDS INSIDE AND OUTSIDE ICH - OVERVIEW

3:30 PM — 4:00 PM

COFFEE BREAK

4:00 PM — 5:30 PM

SESSION 4: eCTD VALIDATION AND REVIEW - BASICS

5:30 PM — 6:30 PM

DRINKS RECEPTION

Day 2 Dec 13, 2016

9:00 AM — 9:15 AM

INTRODUCTION, LOGISTICS AND OVERVIEW OF LEARNING OBJECTIVES

9:15 AM — 10:45 AM

SESSION 5: PREPARING YOUR COMPANY FOR eSUBMISSIONS

10:45 AM — 11:15 AM

COFFEE BREAK

11:15 AM — 12:45 PM

SESSION 6: eCTD NAVIGATION AND CROSS-REFERENCING

12:45 PM — 2:00 PM

LUNCH

2:00 PM — 3:30 PM

SESSION 7: eCTD LIFECYCLE MANAGEMENT

3:30 PM — 4:00 PM

COFFEE BREAK

4:00 PM — 5:40 PM

SESSION 8: GCC eCTD COMPILATION FURTHER DEVELOPMENT OF ELECTRONIC SUBMISSIONS

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Building the eCTD - Practical Solutions to Compiling Electronic Submissions

Agenda

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