Promotional Materials. System Approach. Katie O Brien Associate Senior Consultant Global Quality Systems Eli Lilly and Company

Transcription

1 Promotional Materials and a Quality Management System Approach Katie O Brien Associate Senior Consultant Global Quality Systems Eli Lilly and Company

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 ), its 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. Drug Information Association 2

3 Objectives: Introduce Quality Management System (QMS) QMS: one approach for promotional materials (PMs) Lifecycle of PMs Drug Information Association 3

4 Background: QMS Other references: ICH Q10: Pharmaceutical Quality System ICH Q8: Pharmaceutical Development (QbD) ICH Q9: Quality Risk Management (QRM) article/quality-guidelines.html Adopted in manufacturing as the way to achieve quality/regulatory l t expectations ti Drug Information Association 4

5 Why try a QMS approach with PMs? Facilitates Voluntary Compliance: Objective is to have compliant promotion and not have violative promotion in the marketplace. Violative promotion needs to be addressed by enforcement actions Tom Abrams- FDA,,OPDP (2010 DIA conference) FDA and other regulatory authorities foster such approaches [QbD and QRM] Leslie Ball, M.D and Ann Meeker-O Connell FDA Building Q into Clinical Trials- A Regulatory Perspective Drug Information Association 5

6 What is a Quality Management System? QMS is a: systematic, organizational structure needed to ensure a product [e.g., PMs] meets expectations. Diagram by Karn G. Bulsuk ( Drug Information Association 6

7 QMS offers a way to enable: compliant PM in the marketplace (Compliance) a process that is monitored and institutionalized (Sustainable) the ability to respond to changing expectations (Continuous Improvement) Drug Information Association 7

8 ICH Q10: Pharmaceutical Quality System Lifecycle of Drug Product per ICH Q10 Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Lifecycle of Promotional Material (PM) Development and Approval Production Dissemination Discontinuation Drug Information Association 8

9 The Quality Management System- Defined Requirements Management Responsibility Procedures People Quality Management System is a combination of 4 elements (requirements, procedures, people and management responsibility), which assure that the output meets the defined quality objectives in a manner that is based on good science and appropriate risk management, drives continuous improvement, and meets regulatory requirements and company values. 9

10 Quality System Approach Sports Theme Q Objective: To win the game To play safely To play fair What Rules R l of the Game Tournament Regulations How The Team Play Book Position on team = role/responsibility Management Responsibility Team Owners Team Coaches Referees League Officials Game Reviews Rules Reviewed Who Team Coaches Players on the team 10

11 Quality System Approach PM Q Objectives: To create accurate, truthful and non-misleading material To produce what was actually approved To disseminate at the right time, to the right audience What Federal Regulations OUS Regulations Learned Lessons Internal Business Expectations How Designed to meet the What Job Specific Processes Procedures Social Media Management Responsibilities Escalation process defined Metrics Audit Who Capable and trained Marketing Medical Regulatory Legal 11

12 QMS Lifecycle of PM Development and Approval Production Dissemination Discontinuation Q: How does the organization ensure each step in the lifecycle l occurs as designed? d? A: Design a robust Control Strategy Q: What is a Control Strategy? A: Specific measures identified and implemented to manage risk and reduce errors Science Based Decisions Risk Based Decisions Drug Information Association 12

13 ICH Q9: Quality Risk Management (QRM) Risk Assessment Risk Control Risk Review What might go wrong? How severe would it b? be? How likely is it to happen? What checks and verifications are needed? What should be documented? Who should conduct certain steps? Monitor the performance and trends? Are the controls working? Are the risks changing? Drug Information Association 13

14 Control Strategy Example for Production of PM Development and Approval Production Dissemination Discontinuation Drug Information Association 14

15 QMS: What s next? Development and Approval Production Dissemination Discontinuation Four Elements of the QMS: Requirements Procedures People Management g responsibility Must Implement Core Quality System Elements: Process to monitor performance and quality Process to detect errors and implement fixes Process for management review Drug Information Association 15

16 Shameless Advertisement Poster Presentation on same topic. Abstract #44796 Drug Information Association 16

17 Acknowledgements Co-authors David Fryrear, Advisor Global Quality Systems Tim Grey, Consultant Global Quality Systems Drug Information Association 17