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
Mission3 Regulatory Information Management at DIA EDM
Global Submission Strategies:<br />Management of Product Registrations in a Global Regulatory Environment<br />Automating Regulatory Information Management<br />Dirk K Beth - CEO<br />
Disclaimer<br />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. <br /> <br /> 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. <br />www.diahome.org<br />Drug Information Association<br />2<br />
What are some questions we are trying to answer?<br />Tracking<br />What class 3 products do we have registered in the ASEAN region?<br />Where is the Acme 123 Product registered? Where will it be registered in the next 3 quarters?<br />What is the classification of Acme 123 in China?<br />Correspondence Management<br />What did we do when the MHW asked about this document?<br />Planning<br />How many products will we have registered in Q4 2012 compared to today?<br />When can we submit the EU marketing application?<br />Where-used<br />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?<br />Regulatory Intelligence<br />What will we have to submit for marketing renewal in ASEAN region for XYZ combination product?<br />www.diahome.org<br />Drug Information Association<br />3<br />
1 x 5000 x 80 = 400,000<br />company | products | regions | registrations<br />
Submission and Product Metadata</li></ul>1 global product yields <br />~10,000,000<br />regulatory data points*<br />Drug Information Association<br />www.diahome.org<br />6<br />
Companies Experiencing More Complexity<br />Capitalizing on Complexity - Insights from the Global Chief Executive Officer Study<br />Drug Information Association<br />www.diahome.org<br />7<br />
Where are you going to spend your time?<br /><ul><li>Regulatory Operations teams are already under pressure.
If asked for information during critical submission time - something has to give.</li></ul>Drug Information Association<br />www.diahome.org<br />8<br />
Regulatory Productivity<br />Regulatory Information<br />Not Both <br />
Where are you going to spend your time?<br />$900,000.00 <br />per Annum<br />in salary <br />for a medium size regulatory group<br />$3,000,000.00 <br />per DAY<br />in lost sales<br />30%* OF REGULATORY <br />OPERATIONS TIME IS SPENT LOOKING FOR INFORMATION<br />Drug Information Association<br />www.diahome.org<br />10<br />
No collaboration</li></li></ul><li>Regulatory Information Management - Definition<br /><ul><li>The tracking of product registrations, content and other meta-information for regulated products in a global enterprise to better enable decision making about product portfolios.
The codifying and maintaining of regional regulatory knowledge in a centralized and reproducible system.
The planning of global and local regulatory activity so as to synchronize efforts for maximum efficiency of enterprise regulatory resources.</li></ul>Drug Information Association<br />www.diahome.org<br />12<br />
Regulatory Information Management<br />Tracking = Business Intelligence<br /><ul><li>Easy access to configurable information (Dashboards, charts, exportable reports)
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
Integration (removal of process and data silos)
Normalization of metadata across enterprise systems</li></ul>BERLIN<br />Drug Information Association<br />www.diahome.org<br />3<br />16<br />
Business Intelligence<br /><ul><li>Business Intelligence (BI) refers to computer-based techniques used in spotting, digging-out, and analyzing business data.
Business Intelligence technologies provide historical, current, and predictive views of business operations.
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.</li></ul>Drug Information Association<br />www.diahome.org<br />17<br />
How - Integration of silo’d process & system<br />ERP<br />Documentum<br />Submission Publishing<br />Databases<br />OpenText<br />Labeling System<br />SharePoint<br />Clinical IWR<br />Global Regulatory Standards<br />Regulatory Submission<br />Quality System<br />SAP<br />Drug Information Association<br />www.diahome.org<br />18<br />
Business Intelligence<br /><ul><li>What happened?
Product Name</li></ul>One Definitive Truth<br />- No double entry<br />- Trusted Data Sources<br />- Easily find & report data<br />Drug Information Association<br />3<br />
The challenges RIM is designed to solve<br />Challenges<br />Solutions<br /><ul><li>FTEs are taken off task to locate and aggregate information from disparate systems worldwide
Days are wasted while other critical work is neglected; deadlines do not change
Tracking information is inaccurate or outdated since aggregation process is manual
How do we know what products, from which division, are registered or approved in which region or country?
When was correspondence from an agency received and how did we react to it?
Managers have ready access to information via reporting platform that integrates with existing systems
RA personnel can continue to work uninterrupted
Real-time information is provided without error-prone manual processes
Configure any report based on the information you are looking for and get the information back in real-time
See all regulatory correspondence in relationship to other temporal activity</li></ul>Drug Information Association<br />www.diahome.org<br />21<br />
The challenges RIM is designed to solve<br />22<br />Business<br />Intelligence<br />Eliminate<br />Data Entry<br />RIM<br />Report<br />Normalization<br />Logistics<br />Integration<br />Drug Information Association<br />www.diahome.org<br />