“You Want To Do What?!!!” Recognizing and Resolving Ethical Dilemmas and Compliance Issues in the Conduct of Research: Agenda

7:00 am to 7:45 am

Continental Breakfast

7:45 am to 8:15 am

Welcome and Introduction

8:15 am to 9:15 am

Keynote Presentation: Research Ethics - What and Why it matters to you.
Presenter:  John Z. Sadler, M.D.

9:15 am to 9:30 am

Break

9:30 am to 10:30 am

Presentation: Research Ethics part II/Panel Discussion - Do you see what I see?  Making sure your Ethical Glasses are clear
Presenter:  Robert Bash MD & John Z. Sadler MD

10:30 am to 12:00 pm

Presentation: Compliance with the FDA Guidances on Investigator Responsibilities and the Form 1572 - Or How to Avoid Getting a Warning Letter
Presenter:  P. Below Consulting, Inc.

12:00 pm to 1:00 pm

Lunch

1:00 pm to 2:30 pm

Presentation: Conducting Studies to the International Gold Standard - Going Beyond What the FDA Requires
Presenter:  P. Below Consulting, Inc.

2:30 pm to 2:45 pm

Break

2:45 pm to 4:15 pm

Presentation: A Tale of Two Cities - Working Between the Different Worlds of Pharmaceuticals and Medical Devices
Presenter:  P. Below Consulting, Inc.

4:15 pm to 4:30 pm

Closing Remarks and Conference Evaluation Submission