What’s New for MedDRA Version 18.1

MSSO Achieves ISO 9001:2008 Recertification Update on 27th SOC Product issues

Points to Consider Documents

MDB Update Available in 2015

Thanks to Volunteer Testers

MVAT Access Available to JMO Users

User Group Meetings

Friend of MedDRA Awards

New Webinar: Getting Started with MedDRA

September 2015 Published by MedDRA MSSO for our Users

Quick Links:

Follow us on MedDRA trademark is owned by IFPMA on behalf of ICH

What’s New for MedDRA Version 18.1 By Brian J. O’Hare Terminology Maintenance Manager

1

No new SMQs were added to MedDRA Version 18.1, but there were 292 approved changes to existing SMQs. This included 225 PTs added to existing SMQs, 38 changes related to PT demotions, 22 changes related to promotions, 6 changes to PT status and 1 PT scope change. Only minor changes were made to the SMQ Introductory Guide.

Please see the What’s New document included with the Version 18.1 release package for details.

For more detailed information on MedDRA term additions and changes, users may wish to use the MedDRA Version Analysis Tool (MVAT) – https://mssotools.com/mvat - which is an online tool that compares any two MedDRA versions – including non-consecutive versions – to identify changes. The output of MVAT is similar to the Version Report. MVAT is free to MedDRA users as part of their subscription. The updated MVAT, which was released on 27 May 2015, includes a number of enhancements including user interfaces and data reports in all MedDRA languages. Please see the article “MVAT Access Available to JMO Users” in this edition of the Messenger.

The MSSO encourages MedDRA users to consider submitting change requests to help us maintain MedDRA as a rigorous terminology that is responsive to your needs. Change requests can be submitted to the MSSO via the online change request application WebCR – https://mssotools.com/webcr.

MedDRA Version 18.1 was made available to MedDRA users on 1 September 2015 from the Downloads page on the MedDRA website. MedDRA Version 18.1 is a simple change version which means that changes are made at the PT and LLT levels only. There were a total of 1,799 change requests processed for this version; 1,323 change requests were approved and implemented, and 431 change requests were not approved. There are, in addition, 45 change requests suspended for further consideration and resolution beyond this version. The changes include 751 new PT and LLTs, 21 promotions of LLTs to the PT level, 50 demotions of PTs to the LLT level, and 20 changes to LLT currency status. See the table below for MedDRA Version 18.1 term counts. The implemented changes included “Proactivity requests” to address the placement of hemorrhage and hematoma terms and the placement of “tinea” infection concepts.

Number of Terms in MedDRA Version 18.1

System Organ Classes (SOC) 26

High Level Group Terms (HLGT) 335

High Level Terms (HLT) 1,721

Preferred Terms (PT) 21,612

Lowest Level Terms (LLT) 53,368

2

MSSO Achieves ISO 9001:2008

Recertification

By Mike Burke MedDRA MSSO QA Manager

The MedDRA MSSO is pleased to announce that, effective 31 August 2015, it has successfully achieved an ISO 9001:2008 recertification from BSi™, a quality management systems registrar. The ISO 9001:2008 standard is an internationally recognized quality management system standard developed by the International Organization for Standardization (ISO).

To be certified to the standard, enterprises must implement a Quality Management System (QMS) encompassing the activities of the enterprise for controlled product planning, training on roles and responsibilities in the QMS, controlled development of products, controlled purchasing of materials and services, and controlled delivery of the products and services. Certification to ISO 9001:2008 reinforces to MedDRA users through an independent third-party that the MSSO operates a QMS in accordance with the standard. Pat Revelle, MSSO Director, notes "We are extremely proud to be recertified to the ISO 9001:2008 standard. It demonstrates our commitment to MedDRA users that the MSSO is heavily engaged in continuing process improvement, world-class performance, and monitoring our terminology maintenance operations to ensure that we deliver on the commitments we make to our users, staff, and vendors." The MSSO achieved its first certification to the ISO 9001:2000 standard on 14 November 2003. The MSSO achieved certification to the ISO 9001:2008 standard on 18 August 2009 and now recertification to the same standard on 31 August 2015. BSi™ is a trademark of BSI Management Systems America, Inc.

Update on 27th SOC Product issues By Judy Harrison, MD Chief Medical Officer

The ICH MedDRA Management Board has endorsed the creation of an additional (27th) System Organ Class for implementation in MedDRA Version 19.0. SOC Product issues will include terms relevant for issues with product quality, devices, product manufacturing and quality systems, supply and distribution, and counterfeit products.

An Expert Working Group comprising the MSSO, JMO, and representatives from regulatory authorities and industry with expertise in MedDRA and in product quality provided input on the proposed structure and contents of the new SOC. The MedDRA Version 19.0 complex change proposals have been posted on the Change Requests page of the MedDRA website and the MSSO encourages MedDRA users to submit their comments through 25 September 2015. Once the proposals are finalized and approved, the HLGTs and HLTs will be populated with existing PTs and LLTs, and users will be able to submit Change Requests to add new terms to the hierarchy (see the timeline below).

For more information on SOC Product issues, please visit the 27th SOC page on the MedDRA website and watch for other communications from the MSSO such as webinars, broadcast emails, and presentations.

3

4

Points to Consider Documents By Judy Harrison, MD Chief Medical Officer

The Points to Consider (PtC) documents for MedDRA Version 18.1 are available in English and Japanese and were posted on the MedDRA and JMO websites on 1 September 2015. Starting with this release, the Summary of Changes documents have been replaced by redlined copies of the two PtC documents. The redlined documents identify changes made from the previous to the current release of the documents. It is hoped that this new format will make it easier for users to identify relevant changes for updating their own internal coding and retrieval conventions.

The PtC documents are available in the following formats on the MedDRA Website. Word (“clean” and “redlined”), PDF, and HTML. The PtC Working Group invites MedDRA users to provide feedback on the documents by sending an email to the MSSO Help Desk.

Change to Example in Section 3.15.1.2 in MedDRA Term Selection:

Points to Consider document shown in redline

We want your Feedback! Please contact us:

Email: mssohelp@meddra.org MedDRA website: www.meddra.org Toll Free International: +1.877.258.8280 Direct: +1 703.556.2950 Fax: +1 703.556.1744

MDB Update Available in 2015 By Shalini Gupta IT Support Manager

The MSSO is currently working on an update to the MedDRA Desktop Browser (MDB), which was last updated in 2013. The MDB is a standalone PC application designed to allow a user to search for MedDRA terms and browse the MedDRA hierarchy. The MDB requires users to load the MedDRA files from their PC or a central location within their organization designated by their IT department. The MDB is free to all MedDRA users as part of their subscription. The update will include the following enhancements: • The user interface will closely resemble the Web-Based Browser (WBB) • The user interface language may be changed to any of the available MedDRA languages • On-line access to the latest concept descriptions, MedDRA documentation, and the MDB

user guide • Display, browse, and search up to three languages simultaneously • Support for the unique features of the Japanese translation of MedDRA • Import a previously exported Research Bin

In addition to these features, the MDB will include the following, which will be incorporated in the next WBB update: • Display term hierarchy when exporting both search results and Research Bin • Export SMQs in multiple languages

These updates are expected to be available by the end of summer of 2015. The MSSO will produce an updated videocast on how to use the MDB enhancements. For questions about the new MDB, please contact the MSSO Help Desk.

5

Thanks to Volunteer Testers

The MSSO developeds and maintains software tools for MedDRA users including the MedDRA Desktop Browser (MDB), the MedDRA Web-Based Browser (WBB), and the MedDRA Version Analysis Tool (MVAT). A key step in the development process is to collect feedback from MedDRA users before the new or upgraded software tool is launched. In the past year, the MSSO launched the WBB (December 2014) and an upgraded version of MVAT (May 2015). In both cases the MSSO received valuable feedback from MedDRA volunteer testers that was incorporated into both tools before launch. As a means of expressing our thanks, the MSSO recognizes the following volunteer testers for their efforts to help make these tools as useful as possible:

WBB – Sonja Brajovic (FDA), Christopher Breder (FDA), Sarah Vaughan (MHRA), Hilary Vass (EFPIA), Christina Winter (EFPIA), Kazayuki Sekiguchi (JMO), Dawn Ronan (ICH Secretariat), Carol-Ann Wilson (Bayer), Phil Thompson (AstraZeneca), Kathy Rand (P&G), Ian Slack (Vertex), Morell David (NDA Group), Sharon Germano (Covidien), Sue Lyons (Eisai), Jonathan Keach (GSK), Mike Appruzzese (J&J), Marlo Searcy (Genentech), Hank Dennis (Advanced Clinical)

MVAT – Petra Barth (Boehringer Ingelheim), Sonja Brajovic (FDA), Hank Dennis (Advanced Clinical), Marlo Searcy (Genentech) These testers provided the MSSO with helpful information on how these tools worked in their organization’s environments (e.g., different web browsers), the user interface, and the output of searches and reports. Both of these software tools were improved with the participation of these volunteer testers. If you would like to volunteer to test future software tools please contact the MSSO Help Desk.

By Patrick Revelle MSSO Director

MVAT Access Available to JMO Users By Shalini Gupta IT Manager

Organizations that subscribe to MedDRA through the Japanese Maintenance Organization (JMO) now have access to the MedDRA Version Analysis Tool (MVAT) application (https://tools.meddra.org/mvat) from the MSSO.

MVAT is a web-based application that allows MedDRA users to identify the changes that have occurred between any two MedDRA releases. For more information about MVAT, please go to the following link on the MedDRA website: http://www.meddra.org/versioning. All MSSO users have access to MVAT today by using your MedDRA User ID and password. If your organization subscribes to MedDRA through the JMO, please contact the JMO at info.jmo@pmrj.jp to obtain a user id and password to access MVAT.

6

User Group Meetings

By Brian J. O’Hare Terminology Maintenance Manager

7

MedDRA User Group (UG) meetings are a great way to learn more about MedDRA, MedDRA related topics, ask questions of the MSSO, and network with fellow MedDRA users. The MSSO hosts three User Group meetings per year (US, Europe, and China) and is involved with meetings and webinars hosted by the US and European Industry MedDRA User Groups. The MSSO-hosted meetings feature presentations on a variety of MedDRA related topics presented by regulatory and industry speakers. Recent presentations include:

• European Good Practice Guide on Medication errors presented by Victoria Newbould of the EMA (MSSO EU UG Meeting)

• Update on FAERS MedDRA coding QA program presented by Dr. Sonja Brajovic of the FDA (MSSO US UG Meeting)

• Use of MedDRA in the Review of New Drug Applications presented by Dr. Christopher Breder of the FDA (MSSO US UG Meeting)

• EDC Data and Impact on Safety Processing and SAE Reconciliation presented by Dr. Suzan Shaker of Theorem Clinical Research (MSSO US UG Meeting)

• Update on CDISC Initiatives in China presented by Dr. Zibao Zhang of CDISC China Coordinating Committee (MSSO Chinese UG Meeting)

• Use of Electronic Data Capture in clinical trials presented by Dr. Junchao Chen of Shanghai University of Traditional Chinese Medicine (MSSO Chinese UG Meeting)

• Practical application of SMQs presented by Dr. Sandy Zhang of Pfizer (MSSO Chinese UG Meeting)

Panel discussion on Coding guidelines in Drug safety

at the User Group meeting in Paris France From left to right: Barry Hammond, Terminologeze; Victoria Newbould, EMA; Pat Revelle,

MSSO; Petra Barth, Boehringer Ingelheim; and Morell David, NDA Group

Continued on page 8

Continued from page 7

User Group Meetings (continued)

Dr. Suzan Shaker of Theorem Clinical Research Presenting

at the User Group Meeting in Washington D.C. The MSSO would like to thank the speakers for their interesting presentations and for the time and effort they put in to making the meetings successful. If you are interested in presenting at a future User Group meeting, please contact the MSSO Help Desk. The User Group section of the MedDRA website has information on the dates and locations for upcoming meetings and presentations from past meetings. The next industry meeting will be hosted by Procter & Gamble in Cincinnati, Ohio USA on 18 September 2015 and the European Industry MedDRA User Group will host a webinar on “Medication error coding” on 13 October. Next year’s meetings are scheduled to be in Hamburg Germany on 9 April 2016 and on 30 June 2016 in Philadelphia, Pennsylvania USA. The location and date of the China user group meeting has yet to be determined. Keep checking the User Group section of the MedDRA website for updates. The MSSO encourages you to participate in the User Groups and looks forward to seeing you at the next meeting.

8

9

The MSSO awards the Friend of MedDRA (FOM) medal to those individuals who have made significant contributions to the development and improvement of MedDRA. At the two most recent MSSO User Group meetings (Paris and Washington, DC), two more awardees were recognized for their long time efforts in support of MedDRA.

Victoria Newbould receiving Friend of MedDRA Award in 2015

Ms. Victoria Newbould (EMA) received her FOM medal at the April User Group meeting in Paris for her efforts to promote the use of MedDRA. Ms. Newbould has encouraged the use of MedDRA within the EMA and has frequently participated in industry meetings to provide the regulatory view on coding and analysis with MedDRA as well providing guidance on the use of medication error terms in MedDRA.

At the June meeting in Washington, DC, Dr. Chris Breder (FDA) was recognized for his role as a MedDRA instructor within FDA for clinical reviewers, his active participation in the ICH M1 Points to Consider Working Group, and his role as a representative of FDA on the ICH MedDRA Management Board.

Chris Breder receiving Friend of MedDRA Award Please join me in congratulating Victoria and Chris on their contributions to MedDRA!

Friend of MedDRA Awards By Patrick Revelle MSSO Director

10

New Webinar: Getting Started with MedDRA Is your organization getting ready to implement MedDRA? The MSSO is pleased to offer a free two-hour webinar on the topic of “Getting Started with MedDRA.”

This new addition to the MSSO’s suite of webinars was first presented in June 2015 and is scheduled again on 28 October 2015. An experienced MedDRA instructor will provide a comprehensive overview of MedDRA and how to start using it effectively. The webinar is designed to be of interest to anyone involved with MedDRA including medical/clinical staff, clinical data managers, regulatory specialists, statisticians, programmers, and IT professionals.

Following an overview of the structure, scope and characteristics of MedDRA, practical implementation topics will be covered: downloading and installing MedDRA; versioning; procedures documentation and conventions; legacy data conversion; applications of MedDRA in coding and data retrieval, and IT considerations. There will also be a summary of the many resources available to new MedDRA users including further training opportunities, free software tools, the MedDRA website, the Help Desk, and User Group meetings. As in all the MSSO’s webinars, there will be opportunities to ask questions of the instructor.

Please visit the Training section of the MedDRA website for further information about the new “Getting Started with MedDRA” webinar.

By Judy Harrison, MD Chief Medical Officer

Please visit us at the MedDRA User Group

Meetings 18th US Industry MedDRA User Group Meeting Cincinnati, Ohio USA 18 September 2015 Hosted by: Procter & Gamble European Industry MedDRA User Group Meeting Webinar 13 October 2015 European User Group Meeting Hamburg, Germany 9 April 2016 US User Group Meeting Philadelphia, Pennsylvania USA 30 June 2016