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Mission3 Regulatory Information Management at DIA EDM
- 1. Global Submission Strategies: Management of Product Registrations in a Global Regulatory Environment Automating Regulatory Information Management Dirk K Beth - CEO
- 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. www.diahome.org Drug Information Association 2
- 3. What are some questions we are trying to answer? Tracking What class 3 products do we have registered in the ASEAN region? Where is the Acme 123 Product registered? Where will it be registered in the next 3 quarters? What is the classification of Acme 123 in China? Correspondence Management What did we do when the MHW asked about this document? Planning How many products will we have registered in Q4 2012 compared to today? When can we submit the EU marketing application? Where-used What document and version did we send to Australia for the 3.2.P.3.3 for 100mg Tablet manufactured in the Puerto Rico site? Regulatory Intelligence What will we have to submit for marketing renewal in ASEAN region for XYZ combination product? www.diahome.org Drug Information Association 3
- 4. 1 x 5000 x 80 = 400,000 company | products | regions | registrations
- 5. Absolutely Do This Absolutely Do This Absolutely Do This Do This Absolutely Do This Absolutely Do This Absolutely Absolutely Do This Do This Absolutely 1 x 5000 x 80 = 400,000 company | products | regions | registrations
- 10. Derivative and regional documents
- 12. Source Marketing Submission plans
- 13. Regional Marketing Submission plan
- 14. Renewal plans
- 15. Submission and Product Metadata1 global product yields ~10,000,000 regulatory data points* Drug Information Association www.diahome.org 6
- 16. Companies Experiencing More Complexity Capitalizing on Complexity - Insights from the Global Chief Executive Officer Study Drug Information Association www.diahome.org 7
- 18. If asked for information during critical submission time - something has to give.Drug Information Association www.diahome.org 8
- 19. Regulatory Productivity Regulatory Information Not Both
- 20. Where are you going to spend your time? $900,000.00 per Annum in salary for a medium size regulatory group $3,000,000.00 per DAY in lost sales 30%* OF REGULATORY OPERATIONS TIME IS SPENT LOOKING FOR INFORMATION Drug Information Association www.diahome.org 10
- 22. No corporate wide visibility
- 23. In the hands of individuals
- 24. Can’t look at all the data at once
- 25. Who has the truth?
- 27. The codifying and maintaining of regional regulatory knowledge in a centralized and reproducible system.
- 28. The planning of global and local regulatory activity so as to synchronize efforts for maximum efficiency of enterprise regulatory resources.Drug Information Association www.diahome.org 12
- 30. Which regional or country registration has what status (Submitted to agency, affiliate, etc.) = What can I sell where or WHEN can I sell this there
- 31. Where used = What was sent to who and when
- 32. Correspondence = What was said to who and how did we reactDrug Information Association www.diahome.org 13
- 34. Establish cadence of post-approval registrations for each regionDrug Information Association www.diahome.org 14
- 35. Regulatory Information Management Process Registration & Content Planning= Drug Information Association www.diahome.org 15
- 38. Report (dashboard, comprehensive, configurable)
- 39. Logistics (planning with real data)
- 40. Integration (removal of process and data silos)
- 41. Normalization of metadata across enterprise systemsBERLIN Drug Information Association www.diahome.org 3 16
- 43. Business Intelligence technologies provide historical, current, and predictive views of business operations.
- 44. Business Intelligence aims to support better business decision-making. Business Intelligence uses technologies, processes, and applications to analyze mostly internal, structured data and business processes.Drug Information Association www.diahome.org 17
- 45. How - Integration of silo’d process & system ERP Documentum Submission Publishing Databases OpenText Labeling System SharePoint Clinical IWR Global Regulatory Standards Regulatory Submission Quality System SAP Drug Information Association www.diahome.org 18
- 48. Why did it happen?
- 50. What do I want to happen?Past Present Future People / Departments Regional Agencies / Affiliates Executives / Dependents Drug Information Association www.diahome.org 3 19
- 52. Catalog Number
- 55. Catalog Number
- 56. Submission Name
- 57. Application #
- 58. Region
- 59. Country
- 60. Where Used
- 62. Correspondence
- 65. Application #
- 66. Product Name
- 67. Catalog Number
- 68. Region
- 69. Country
- 71. Document Status
- 72. Document Version
- 73. Product NameOne Definitive Truth - No double entry - Trusted Data Sources - Easily find & report data Drug Information Association 3
- 75. Days are wasted while other critical work is neglected; deadlines do not change
- 76. Tracking information is inaccurate or outdated since aggregation process is manual
- 77. How do we know what products, from which division, are registered or approved in which region or country?
- 78. When was correspondence from an agency received and how did we react to it?
- 79. Managers have ready access to information via reporting platform that integrates with existing systems
- 80. RA personnel can continue to work uninterrupted
- 81. Real-time information is provided without error-prone manual processes
- 82. Configure any report based on the information you are looking for and get the information back in real-time
- 83. See all regulatory correspondence in relationship to other temporal activityDrug Information Association www.diahome.org 21
- 84. The challenges RIM is designed to solve 22 Business Intelligence Eliminate Data Entry RIM Report Normalization Logistics Integration Drug Information Association www.diahome.org
- 85. Dirk’s Contact Info Dirk KarstenBeth | Chief Executive Officer | Mission3, Inc. @dirkbeth @regtrack Group: Registration Tracking www.mission3.com dirk@mission3.com Drug Information Association www.diahome.org 23
Notes de l'éditeur
- Intro – Dirk Beth – CEO of Mission3 – RIM software company. Mission3 was really the first company to provide comprehensive tools for submission and content planning as well as provide automated business intelligence around the regulatory process about 6 years ago.Along w my colleagues (Brooke Casselberry and Jorg Schnitzler) I will be discussing Global Submission StrategiesThe flow will go like this. I will be covering high-level approach for RIM at global companies. Then we will discuss changes in the Reg Intelligence landscape for extra-US countries. And finally we will look at a specific case of product registration to the Swiss health authorities.
- Obligatory Disclaimer Slide
- In order to give you an idea of the magnitude of the problem, I want to present to you the situation. I find that often time we have a feeling that there is an issue but I have found that people do not often step back to understand the enormity and true complexity of the exact challenge that they deal with on a daily basis.
- In order to give you and idea of the magnitude of the problem, I want to present to you the situation. I find that often time we have a feeling that there is an issue but I have found that people do not often step back to understand the enormity and true complexity of the exact challenge that they deal with on a daily basis.
- This model leaves companies with the choice. Regulatory Productivity – the process of creating and maintaining regulatory assets such as submissions and registrationsVSRegulatory Information – the metadata and business intelligence about the regulatory processCan’t ask FTEs for both without losing value in both areas.
- The problem with silo’d data and processes are that individuals create their own “Best Way” to solve the problem.Most companies have a number of spreadsheets and document artifacts which are managed by individuals who are distributed out across the world. They rely on different sources of information to populate their spreadsheets. Re-entering information from a trusted system into an untrusted spreadsheet.* The way they store, classify, and organize information is inconsistent.* It is not possible to look at the information across the enterprise if the information is so different and locked away* Information cannot be compared or “sliced and diced”* Who has the truth?* Not able to collaborate internally or externally
- Another view of the model is business intelligences ability to provide informationAND the sources of that data