会议日程

天 1 2017 年 10 月 23 日

7:30 AM — 8:30 AM

Registration and Continental Breakfast

8:30 AM — 8:45 AM

Introduction and Pre-Recorded Session 1: Drug Development: An Overview

8:45 AM — 9:00 AM

Session 2: The IND – A General Introduction

9:00 AM — 9:45 AM

Session 3: The IND in Detail - Modules 1, 2, and 5

9:45 AM — 10:15 AM

Refreshment Break

10:15 AM — 12:00 PM

Session 4: Special Topics for Clinical Research

12:00 PM — 12:30 PM

Session 5: IND in Detail - Module 3

12:30 PM — 1:30 PM

Luncheon

1:30 PM — 2:15 PM

Session 6: The IND in Detail - Modules 4 and 5

2:15 PM — 2:45 PM

Session 7: The IND in Detail - Additional Topics

2:45 PM — 3:15 PM

Refreshment Break

3:15 PM — 4:00 PM

Session 8: Quality Assurance in Drug Development (GxPs)

4:00 PM — 4:30 PM

Session 9: FDA's Actions on the Original IND and Future Amendments

4:30 PM — 5:00 PM

Session 10: IND Amendments and Maintenance

5:00 PM — 6:00 PM

Reception

天 2 2017 年 10 月 24 日

7:30 AM — 8:00 AM

Continental Breakfast

8:00 AM — 8:30 AM

Session 10: IND Amendments and Maintenance (continued)

8:30 AM — 9:30 AM

Session 11: Workshop - IND Amendment

9:30 AM — 10:30 AM

Session 12: Special Regulatory Considerations for Development

10:30 AM — 11:00 AM

Refreshment Break

11:00 AM — 11:45 AM

Session 13: Reporting Adverse Events (AEs) During Clinical Trials

11:45 AM — 12:30 PM

Session 14: Workshop: AE Reporting

12:30 PM — 1:30 PM

Luncheon

1:30 PM — 2:30 PM

Session 15: The NDA in CTD Format: Types of NDAs

2:30 PM — 3:00 PM

Refreshment Break

3:00 PM — 5:00 PM

Session 16: The NDA in CTD Format: Modules 1-5

天 3 2017 年 10 月 25 日

7:30 AM — 8:00 AM

Continental Breakfast

8:00 AM — 9:00 AM

Session 16: The NDA in CTD Format

9:00 AM — 10:30 AM

Session 17: The NDA in CTD Format: How to Submit an Action on Applications

10:30 AM — 11:00 AM

Refreshment Break

11:00 AM — 12:00 PM

Session 18: The FDA and Risk Management

12:00 PM — 1:00 PM

Luncheon

1:00 PM — 2:15 PM

Session 19: Regulatory Requirements for Prescription Drug Labeling

2:15 PM — 3:30 PM

Session 20: Post-NDA Approval Regulatory Requirements

3:30 PM — 4:30 PM

Session 21: Post Approval Workshop (includes a 15 minute refreshment break)

4:30 PM — 5:00 PM

Preparation for Mock FDA Meeting

天 4 2017 年 10 月 26 日

7:30 AM — 8:00 AM

Continental Breakfast

8:00 AM — 9:15 AM

Session 22: Interactions with FDA - Part 1

9:15 AM — 10:30 AM

Session 23: Interactions with FDA - Part 2

10:30 AM — 10:45 AM

Refreshment Break

10:45 AM — 12:45 PM

Session 24: Mock FDA Meeting

12:45 PM — 1:45 PM

Luncheon (Inspection Video: Optional)

1:45 PM — 3:00 PM

Session 25: Regulatory Compliance and FDA Inspections: What To Expect After Submitting the NDA

3:00 PM — 3:30 PM

Refreshment Break

3:30 PM — 4:30 PM

Session 26: Review of Prescription Drug/Biologics Advertising and Promotional Labeling

4:30 PM — 5:00 PM

Feedback and Wrap-up

Regulatory Affairs: The IND, NDA, and Postmarketing

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