MedDRA Update

MedDRA User Group MeetingHyderabad India12 March 2019

Topics

• MedDRA 20th Anniversary• Subscription changes 2019• MedDRA Translations• New MSSO Staff• MedDRA Documents• WEB-RADR • MedDRA Training• Overview of MedDRA IT Tools

2

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

3

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

4

MedDRA Translations

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

6000286

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

7000286

2019 MedDRA Subscription Rate Table

8

77% of all MedDRA users pay no fee or 

$688 (or less)

5% Reduction from 2018 rates

New MSSO Staff

MSSO Organization

10

• 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

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

New MSSO Staff

12

Dr. Amanda Saunders Dr. Carol‐Ann Wilson

Dr. Ali Awan

Ana García Rubio

Yun Hui Do

Update on Points to Consider (PtC) Documents, MedDRA Best Practices Document, User Documents

PtC Documents

14

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

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

15

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 - mssohelp@meddra.org

16

Support Documentation

17

• 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

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

18

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

19000244

WEB-RADR 2

(WEB Recognising Adverse Drug Reactions)

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

21

Consortium members

WEB-RADR 2 Consortium Meeting

2 November 2018 at MHRA, UK

23

MedDRA Training

MSSO Free Training Program

• Formats–Face-to-face sessions, webinars, videocasts, YouTube Channel

• Languages–English, French, German, Spanish, Mandarin Chinese

• Locations–Worldwide and “virtual”

25

Face to Face Training Session Titles

• Coding with MedDRA• Safety Data Analysis and Standardised

MedDRA Queries (SMQs)• Getting Started with MedDRA

26

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

27

Face to Face Training Tab

28

Webinar Training Tab

29

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– mssohelp@meddra.org 30

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

31

MedDRA IT Tools

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

second quarter 2019 33

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

34

WBB 3.0 Secondary SOC Information

35

• 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

WBB 3.0 Secondary SOC Information (cont)

• Example export with Secondary SOC information*

36

*Primary SOC hierarchy information is included by default

SMQ Analysis

• Purpose – assist MedDRA users in applying SMQs to their coded data

• Input:

37

SMQ Analysis (cont)

38

SMQ Analysis (cont)

• Output:

39

Planned MVAT 3.0 Updates

• Ability to run reports on supplemental changes

• Option to include secondary SOC changes• Expected second quarter 2019

40

MVAT 3.0 – Secondary SOC Information

41

Secondary SOC information also available in Data Impact Report

000286

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

42

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

43

Application Program Interfaces -Examples

44

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

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?

45

Home Page

46

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

Thank You

Questions?