msso meddra update 2019 hyderabad india...• msso is seeking locations to host free training in...
TRANSCRIPT
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MedDRA Update
MedDRA User Group MeetingHyderabad India12 March 2019
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Topics
• MedDRA 20th Anniversary• Subscription changes 2019• MedDRA Translations• New MSSO Staff• MedDRA Documents• WEB-RADR • MedDRA Training• Overview of MedDRA IT Tools
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20 Years of MedDRA
• In 2019 the MSSO will be celebrating twenty years of MedDRA– First release of MedDRA (version 2.1) on 1 March 1999– MedDRA was originally provided on diskettes and hardcopies were
available for an additional charge
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Many Contributors to MedDRA
• ICH M1 Expert Working Group developed MedDRA• ICH’s decision to establish a dedicated maintenance and
support organization to high standards• MSSO staff efforts to develop and refine processes and
policies for maintenance, subscriptions, and training• Most significantly, the role of MedDRA users to improve
MedDRA and drive the MSSO to meet their needs• MSSO acknowledges and thanks MedDRA users and we look
forward to our continued partnership
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MedDRA Translations
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MedDRA Translations
• Currently MedDRA is available in 12 languages –Chinese, Czech, Dutch, English, French, German, Hungarian, Italian, Japanese, Portuguese, Russian, and Spanish
–Translation includes all terms and documentation
• Currently working on Korean and Brazilian Portuguese translation–Release dates to be determined
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2019 MedDRA Subscription Rates
• Effective 1 January 2019, additional $850 subscription fee for the Japanese translation of MedDRA has been eliminated
• MSSO subscribers receive all MedDRA languages with their subscription at no additional cost
• All 2019 MedDRA subscription rates have been reduced 5% from 2018 levels
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2019 MedDRA Subscription Rate Table
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77% of all MedDRA users pay no fee or
$688 (or less)
5% Reduction from 2018 rates
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New MSSO Staff
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MSSO Organization
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• 39 full and part time staff members• Mix of Medical Professionals (MDs, nurse, etc.) IT, data
managers, project support, finance
MSSO Director
Business Operations
Terminology Development and Services
Help Desk
Training
Terminology Maintenance
IT Support
MedDRA Maintenance
Quality Assurance
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New MSSO Staff
• MSSO has hired new US-based staff for program development–They will support MedDRA mapping initiatives and
terminology maintenance• MSSO has hired locally-based support staff for the
Republic of Korea and Argentina (supporting Latin America)–They will provide support (e.g., Help Desk, training) for
local MedDRA users• MSSO has also hired a part-time trainer based in
Germany• Additional locally-based support staff hires are
planned for China and India by the end of 201911
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New MSSO Staff
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Dr. Amanda Saunders Dr. Carol‐Ann Wilson
Dr. Ali Awan
Ana García Rubio
Yun Hui Do
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Update on Points to Consider (PtC) Documents, MedDRA Best Practices Document, User Documents
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PtC Documents
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PtC Category PtC Document Purpose Languages Release CycleTerm Selection MedDRA Term Selection:
Points to ConsiderPromote accurate and consistent coding with MedDRA
English and Japanese
Updated with each MedDRA release
MedDRA Term Selection: Points to Consider Condensed Version
Shorter version focusing on general coding principles to promote accurate and consistent use of MedDRA worldwide
All MedDRA languages (except English and Japanese)
Update as needed
Data Retrieval and Presentation
MedDRA Data Retrieval and Presentation: Points to Consider
Demonstrate how data retrieval options impact the accuracy and consistency of data output
English and Japanese
Updated with each MedDRA release
MedDRA Data Retrieval and Presentation: Points to Consider Condensed Version
Shorter version focusing on general retrieval and analysis principles to promote accurate and consistent use of MedDRA worldwide
All MedDRA languages (except English and Japanese)
Update as needed
General MedDRA Points to Consider Companion Document
More detailed information, examples, and guidance on specific topics of regulatory importance. Intended as a “living” document with frequent updates based on users’ needs. First edition covers data quality and medication errors.
English and Japanese
Updated as needed
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PtC Updates v22.0
• Includes a mention of the Condensed Versions of PtC documents
• Term Selection document–Minor text changes in Exposures during Pregnancy and Breast Feeding section 3.10
• Data Retrieval and Presentation document–Added references to new Hierarchy Analysis and SMQ Analysis functions in MSSO browsers
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PtC Companion Document
• Reviewing feedback from users on medication errors section
• Plan to update in Q1/2 2019• Initial draft of new product quality
section underway• Send questions and comments to the
MSSO Help Desk - [email protected]
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Support Documentation
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• Condensed PtC documents available in all MedDRA languages except English and Japanese
• MedDRA Best Practices document available in all MedDRA languages
• Russian now available in v22.0
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MedDRA Best Practices Document
• Objective is to promote accurate and consistent use of MedDRA
• Sections on primary SOC allocation, versioning, supplemental terms
• Endorsed by MedDRA Management Committee
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MedDRA User Guides
• Specific to each release
• Includes:– MedDRA
Introductory Guide
– SMQ Introductory Guide
– What’s New – MedDRA file
format (schema) • Same documents
included with MedDRA download package
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WEB-RADR 2
(WEB Recognising Adverse Drug Reactions)
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WEB-RADR 2
• WEB-RADR 2 project funded by Innovative Medicines Initiative (IMI)
• ICH is a partner– MSSO participating as ICH’s subcontractor
• 18 month project (Sep 2018 – Feb 2020)• Work Package 4 “Terminology Mapping and Maintenance”
– Goal is to develop a bi-directional mapping between SNOMED CT and MedDRA
– Develop licensing and distribution agreements– Develop ongoing maintenance processes
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Consortium members
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WEB-RADR 2 Consortium Meeting
2 November 2018 at MHRA, UK
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MedDRA Training
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MSSO Free Training Program
• Formats–Face-to-face sessions, webinars, videocasts, YouTube Channel
• Languages–English, French, German, Spanish, Mandarin Chinese
• Locations–Worldwide and “virtual”
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Face to Face Training Session Titles
• Coding with MedDRA• Safety Data Analysis and Standardised
MedDRA Queries (SMQs)• Getting Started with MedDRA
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Webinar Titles
• MedDRA Overview• Getting Started with MedDRA• MedDRA Coding Basics• Advanced MedDRA Coding• Data Analysis and Query Building with
MedDRA• Standardised MedDRA Queries (SMQs)• What’s New with MedDRA and the MSSO
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Face to Face Training Tab
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Webinar Training Tab
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Host for Free Training?
• MSSO is seeking locations to host free training in India. – Could be at regulator or company site– Host can send 5 attendees – Host must allow other MedDRA users to attend– MSSO handles registration
• Qualifications– A conference room for 25-30 people– A projector and a screen– Guest WiFi
• Please contact MSSO Help Desk if you are interested in hosting training– [email protected] 30
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Social Media
• MSSO is developing a social media strategy to improve communications with MedDRA Users
• What social media platforms are used in India? • MSSO is looking to establish networks to improve
contacts –Spread the word about events such as free training
classes and user group meetings
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MedDRA IT Tools
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Web-Based Browser 3.0
• Major new features: –Ability to view supplemental changes–Upload terms to extract primary and secondary links
• Option to export secondary SOC links from the Research Bin and Search results
–Upload terms to run against SMQs• Options to use algorithmic and hierarchical SMQs
• Available as of October 2018• MedDRA Desktop Browser update expected in
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Web-Based Browser 3.0
• Purpose of Supplemental view in WBB 3.0:– Displays changes to MedDRA for the next release
immediately after approval– Improves transparency vs. current supplemental posting
• Not the default view
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WBB 3.0 Secondary SOC Information
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• Option to extract Secondary SOC* information: – Separate feature
to upload MedDRA terms and extract hierarchy in formation
– Exporting from the research bin
*Primary SOC is the default
Optional Secondary SOC hierarchy
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WBB 3.0 Secondary SOC Information (cont)
• Example export with Secondary SOC information*
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*Primary SOC hierarchy information is included by default
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SMQ Analysis
• Purpose – assist MedDRA users in applying SMQs to their coded data
• Input:
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SMQ Analysis (cont)
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SMQ Analysis (cont)
• Output:
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Planned MVAT 3.0 Updates
• Ability to run reports on supplemental changes
• Option to include secondary SOC changes• Expected second quarter 2019
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MVAT 3.0 – Secondary SOC Information
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Secondary SOC information also available in Data Impact Report
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Mobile WBB
• Mobile MedDRA Browser–Search MedDRA terms and codes via a mobile platform
–Smart Phone–Tablet
• Similar features as the Web-Based Browser• Some features may be limited due to
constraints of the mobile platform –Expected in middle of 2019
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MedDRA APIs
• MedDRA Application Program Interface (API) –Software building blocks to provide the best features of MSSO tools (e.g., WBB, MVAT)
–Allows users to develop their own MedDRA tools
–Provides a proven tool that accurately depicts MedDRA
–Expected early 2020
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Application Program Interfaces -Examples
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API
API
Input
Input
Outputs
Outputs
Request: SMQ Analysis
Request: MedDRA hierarchy
Data: List of MedDRA Terms MedDRA primary
& Secondary SOC hierarchy information
List of SMQ matches per the inputted term list
Data: List of MedDRA Terms
The user does not need to know how to apply the input data against MedDRA
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MedDRA Self-Service Application
• Improve service by providing information to appropriate individuals at any time of day: – Who is my MedDRA point of contact?– What is my MedDRA ID?– Can you confirm the subscription status of my
business partners?– I am a Point of Contact for my subscription, can
you provide me our subscription password?
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Home Page
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https://apps.meddra.org/selfservice
• Videocast available on the MedDRA Website that explains these features in detail.
• Training / Training Materials / Tools
https://youtu.be/APUTfxsK5bU
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Thank You
Questions?