Andrew Williams Senior Director European Medical Operations GlaxoSmithKline Company logo here. Disclaimer

Transcription

1 Fit for the future - A new strategic approach to Medical Information management within GSK Andrew Williams Senior Director European Medical Operations GlaxoSmithKline Company logo here 1 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. 2

2 Strategic drivers for change Manage Risk Enhance Value Efficiency Simplify 3 Vision and strategy Medical Information is defined as: the production, maintenance and delivery of medical information content to unsolicited enquiries from healthcare professionals and consumers Value Proposition: In response to unsolicited enquiries, GSK Medical Information will provide objective and consistent scientific information related to GSK products to enable HCPs to use the right GSK medicine with the right patient at the right time. Strategic Goal: Ensure that all Medical Information responses are accurate, objective specific to question and consistent across all GSK operating companies 4

3 GSK Global MI strategy 5 Governance & Networks Global Europe LOC Estonia GMIE EMIC MI Lead 6

4 SOP & Global Business Rules Global SOP Global Business Rules Ensures all LOC responses are Globally consistent with GSK medical position on the topic Fairly and accurately reflect safety & efficacy data from all GSK studies and other sources Specific to query raised Operational rules covering : Medical Information Content Style Guide Procedures Developed by Global Team Living framework 7 Content Management Global Designate LOC that will take on world-wide responsibility for the development and maintenance of Global Medical Information content for assigned product(s) Global Designate model Ensures clear accountability for the development and maintenance of global MI responses according to Global policy and rules Enables GSK to pool and share expertise 8

5 MI System Medical Information Management System: WISDOM (Worldwide Integrated System for Drug and Medical Information) Paradigm Shift: from Document Management to Content Management Documents Content Pieces 9 WISDOM System 10

6 MI Content Hierarchy MASTER (US English) Globally Valid content (Inc References) TRANSLATED (9 languages) Translated Global content Local Response Local Response Local Response Translated Global content plus local Brand name Disclaimer Guidelines SPC (if needed) 11 Medical Information Fulfilment Only providing responses in one of the supported languages (e.g. English, German, Spanish, French) Ensuring first mention, local indication statements & disclaimers are included either via system or cover letter No additional data to be included No local interpretation (eg. in cover letter) Standard format Electronic fulfilment wherever possible No local MI databases 12

7 Fulfilment 2 tier approach Designate/Major Markets Smaller Markets MASTER (US English) or TRANSLATE or + Standar d Cover Letter Local Language Disclaimers LOCAL 13 Implementation US Europe/Biologics APJEM Designate + fulfilment Live Designate Fulfilment Designate Fulfilment 14

8 Challenges Change management Language Designate model Scope products and businesses Technology Digital Information strategy 15 Critical Success factors Corporate strategy Trans-national Pragmatism Evolving business rules Dialogue Regional/Global Teamwork 16