1. Perspective on GCP Warning Letters
DIA GCP and QA SIAC
Perspective on GCP Warning Letters
Sydney A Gilman, PhD
July 27, 2010, 10:00 AM

2. Disclaimer
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), the presenter’s affiliated companies, either DIA or their company directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.
These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
The presenter is presenting his opinion on his perspective of GCP Warning Letters.

3. Regulatory Compliance
Overview
Regulatory Compliance
IND/(A)NDA Regulations
Code of Federal Regulations, Title 21, parts 50, 312 and 314
International Committee on Harmonization
Good Clinical Practice (E6)

4. Overview - Continued Company Compliance
Working within a proposed budget
Challenge and resolve issues economically with focus towards a potential blockbuster
Build a working regulatory strategic plan to ensure success with minimal obstacles
Hire experienced staff to avoid pitfalls and delays

5. Overview - Continued Auditor Compliance
Retain experienced auditors who have interacted successfully with companies
Depend on auditors who know how FDA thinks and how FDA views sites
Rely on auditors who can prepare sites for the 483s
Know that auditors can prepare remediation plans to ensure corrective actions become preventative ones

6. Overview - Continued FDA Compliance
Anticipate skilled Inspectors that follow the flow of Clinical documentation at your site
Preparation of formal notice of observations (form 483) with clarification and rationale to be adequately addressed by the Sponsor/Applicant
Skillfully assessing company responses that adequately and consistently fail to address critical observation(s) which contribute to the preparation of a Warning Letter

7. What’s on Our Minds in a Clinical Study?

8. Recent Warning Letter Examples
Johnson & Johnson – 09-HFD
Ketek – Aventis – 07-HFD
Coast IRB – 09-HFD
ICON CRO - 10-HFD

9. What Could be Worse?
Stopping the Application process/ ban on distribution.
Repeating the clinical study
Consent decree

10. Impact of Actions After Issuance of Warning Letter
Company Actions
Conversion to absolute Regulatory Compliance or digging –in and challenging the system
Layoffs, delays in forecasts, investment decline, credibility
Company Employee Actions:
Compliance to company directives;
Option to look for greener pastures
Starting over

11. Impact of Actions After Issuance of Warning Letter - Continued
Auditor Actions
Maintaining focus to correct and prevent
Regulatory Actions
Revising the development plan to ensure acceptance/approval
Field Actions

12. What Might Help? Developing a Framework that Moves…

13. Embracing Change Building Company Credibility
Maintaining Auditor Credibility
Respecting FDA Credibility

14. Planning for Now and the Future
Don’t be intimidated
Document everything
Focus on solutions
Never try to hide problems

15. FDA Websites for Additional Information

16. Successful Outcomes