What’s New for MedDRA Version 16.1

Meet the New CMO!

MedDRA MSSO New Website and New MedDRA Logo

User Group Meetings

MSSO Maintains ISO 9001:2008 Recertification

MSSO MedDRA Training

Coming Soon for MedDRA Training

September 2013 Published by MedDRA MSSO for our Users

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What’s New for MedDRA Version 16.1 By Brian J. O’Hare Terminology Maintenance Manager

Number of Terms MedDRA Version 16.1

System Organ Classes (SOC) 26

High Level Group Terms (HLGT) 334

High Level Terms (HLT) 1717

Preferred Terms (PT) 20307

Lowest Level Terms (LLT) 72072

In addition to above changes, there were 307 translation correction requests implemented in the non-English versions of MedDRA. Below is a summary of the number of changes implemented and the language affected.

12 Chinese

4 Dutch

32 French

13 German

20 Italian

226 Spanish

Please see the Change Request section of the MedDRA website if you wish to request corrections to a non-English version of MedDRA.

The MSSO encourages MedDRA users to consider submitting change requests identified during MedDRA usage to help us maintain MedDRA as a rigorous terminology responsive to user needs. Change requests can be submitted to the MSSO via the online change request application WebCR (https://mssotools.com/webcr). Please see the following URL for details: http://www.meddra.org/how-to-use/change-

requests.

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MedDRA Version 16.1 was made available to subscribers on 1 September 2013 from the Downloads page on the MedDRA website.

There were a total of 1813 change requests processed for this version; 1356 change requests were approved and implemented, and 320 change requests were not approved. There are, in addition, 137 change requests suspended for further consideration and resolution beyond this version. Below are highlights of v16.1 changes. Please see What’s New Document for details:

A proactive maintenance review to identify and add missing American or British spellings of existing terms throughout MedDRA

A proactive maintenance review to add a set of catheter site terms

A proactive maintenance review of terms relating to the neonatal period.

Four new Level 1 SMQ were released into production in MedDRA v16.1 – SMQ Arthritis, SMQ Myelodysplastic syndrome, SMQ Noninfectious diarrhoea and SMQ Tumour lysis syndrome. There are now 94 Level 1 SMQs in production as of this version. Please see the MedDRA v16.1 SMQ Introductory Guide for specific information about these new SMQs and other SMQ changes made in v16.1.

MedDRA v16.1 is a simple change version which means changes are only made at the PT and LLT levels of the MedDRA hierarchy. Information on specific changes (e.g., new terms added, LLT promotions, PT demotions, PT primary SOC changes, etc.) which occurred since the prior MedDRA release can be obtained via the Version Report included with the English language MedDRA download.

In addition, 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.

Meet the New CMO!

By Pat Revelle MSSO Director

I’m pleased to announce that Dr. Judy Harrison has accepted the position as Chief Medical Officer (CMO) of the MSSO. I expect that many of you know Judy in one of her many previous roles as an MSSO trainer, a member of the ICH M1 “Points to Consider” Working Group, a presenter at DIA meetings, or as the “voice” of the MSSO (for those of you who place a phone call to the Help Desk and reach our recording).

Judy replaces Patricia Mozzicato who left the MSSO on 1 July 2013 to take on another position in industry. Throughout her time at the MSSO, Patricia was a key contributor who demonstrated a true passion for MedDRA that was combined with a deep understanding of the regulated biopharmaceutical industry. We wish Patricia the best in her new position.

Judy graduated from the University of Cambridge (MA) and received her medical degree from the University of Oxford (BM BCh). Post-registration, she held positions in cardiothoracic surgery and anesthetics before pursuing a career in the pharmaceutical industry. She has over 20 years’ experience in clinical research and pharmacovigilance including positions at Bayer in the U.K. and Schering-Plough Research Institute in the U.S. In 2004, Judy joined the MSSO where, as well as training, she has been responsible for providing medical support for terminology maintenance and development activities.

In addition to her work at the MSSO, Judy is an Adjunct Assistant Professor at Rutgers, the State University of New Jersey where she teaches on MedDRA and pharmacovigilance for the Master’s of Science in Clinical Trial Sciences program offered by the School of Health Related Professions. She also chairs a Data Safety Monitoring Board for the National Institutes of Health.

Judy is a dual U.K. and U.S. citizen and has lived in New Jersey in the U.S. since 1991. She is an avid horsewoman who spends much of her free time riding her horse and enjoying the sport of eventing (equestrian triathlon).

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MedDRA MSSO New Website and New MedDRA Logo

By Anna Zhao-Wong, MD, PhD MSSO Deputy Director

Have you visited the MedDRA website lately? The MSSO launched the new MedDRA website with a brand new logo on 23 July 2013. Words from users to describe the website include “beautiful,” “great,” “exciting,” “organized”…!

The new MedDRA logo has a meaningful visual connection to MedDRA terminology. The five vertical bars on the left side represent the five hierarchical levels (i.e., SOC, HLGT, HLT, PT, and LLT) in MedDRA and the globe symbolizes the global harmonization effort of the International Conference on Harmonization (ICH), of which MedDRA is a part.

The blue color in the MedDRA logo, a color often associated with healthcare, is similar to the ICH logo shown below.

The new website has a similar look and feel as the ICH website to identify MedDRA as an ICH product. Users may access the ICH website by clicking on the ICH Logo on the upper right corner of each page in the MedDRA website. The MedDRA website is welcoming and user-friendly. The home page greets viewers with recent news, upcoming MedDRA training classes and access to non-English web pages in all of the MedDRA

languages, i.e., Chinese (中文), Czech (Čeština),

Dutch (Nederlands), French (Français), German (Deutsch), Hungarian (Magyar), Italian (Italiano),

Japanese (日本語), Portuguese (Português), and

Spanish (Español). The non-English web pages provide MedDRA non-English speaking users the opportunity to learn about MedDRA and MSSO services in their native languages.

The new website puts an emphasis on helping new and prospective users get oriented with MedDRA while allowing experienced users quick access to frequently visited pages. Visit the “How to use” areas to learn about MedDRA Basics and Case studies of MedDRA in regulatory use, industry use, implementation planning, SMQs, and academic use.

One of the new features of the MedDRA website is the ability to sign-up a for a MedDRA subscription or renew your subscription online without emailing a PDF attachment or subscription agreement. For new commercial users, after signing up on the Online Subscription Page, you will receive a subscription invoice from the MSSO. Your subscription application process is complete as soon as the payment is received. For current users who have planned subscription renewal in their schedule, renew online so you do not have to wait for the MSSO to send you a subscription renewal notice email.

You can now access all MedDRA release documentation (e.g., Introductory Guide, What’s New) without the trouble of having to enter your User ID, password, and release specific unzip passwords. With the support of the ICH MedDRA Management Board, the MSSO has made MedDRA release documents publicly available. These documents include the What’s New Document, the MedDRA Introductory Guide, the SMQ Introductory Guide, and the MedDRA Distribution File Format Document. MedDRA release documents and the Points to Consider Documents together can be found in the Support Documentation section (this includes English and all MedDRA translations).

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MedDRA User Group 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, EU, and China) and is also involved with meetings hosted by the US and EU Industry MedDRA User Groups. The MSSO-hosted meetings feature presentations on a variety of MedDRA related topics delivered by regulatory and industry speakers. Recent presentations include:

Quality Assurance and MedDRA, presented by Health Canada

EU Legislation - Changes Related to Pharmacovigilance presented by the EMA

Signal Detection and SMQs presented by Novartis Pharma AG

The User Group section of the MedDRA website has information on the dates and locations of upcoming meetings. The next meeting is the US Industry User Group Meeting hosted by Eisai which will be held at Woodcliff Lake, NJ USA on 27 September 2013. Registration for this meeting is open until 13 September. Agendas and presentations from past meetings are also available.

The MSSO encourages MedDRA user participation in these free meetings and looks forward to seeing you at the next meeting.

By Brian J. O’Hare Terminology Maintenance Manager

Terminology Maintenance Manager

User Group Meetings

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MedDRA MSSO New Website and New MedDRA Logo

Registering for free MedDRA Training is easier and faster than ever! In the training schedule page, seat availability is shown for each class. A snapshot of the training schedule as of 12 August 2013 (shown below) shows that there are no seats left for September 17 and 18 classes in Bridgewater, New Jersey US, 1 seat left for September 18 class in Haarlem, Netherlands, and 10 seats left for the September 25 class in Chicago, IL US. Click on the class with available seats and register. You will receive an immediate confirmation upon registration. You may also click on the class without available seats, and register to be added to the waiting list for that class. While you are at the class registration page, do not forget to check out the course material and “meet” your trainer in advance by clicking on the trainer’s name to view his or her picture and a short biographical sketch. For more details about the Training pages on the MedDRA website, please see the article on training in this edition of the Messenger.

MedDRA Training Schedule

MSSO Maintains ISO 9001:2008 Recertification

By Mike Burke

Manager, Quality Assurance

The MedDRA MSSO is announcing effective 21 August 2013, it has successfully maintained its ISO 9001:2008 certification from BSi™, a quality management systems registrar. The MSSO achieved excellent results from a surveillance audit conducted 20-21 August 2013. 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 customers through an independent third-party that the MSSO operates a QMS in accordance with the standard. For example, the MSSO produces a release plan for each MedDRA Release; manages execution of the plan by monitoring and measurement through product and process verifications; and delivers the prescribed products on time with the correct resources.

Pat Revelle, MSSO Director, notes "We are extremely proud of our continuing certification 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 again on 31 August 2012. BSi will continue to conduct annual routine surveillance audits of the MSSOs business operations.

BSi™ is a trademark of BSI Management Systems America, Inc.

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We want your Feedback! Please contact us: Email: mssohelp@meddra.org Website: www.meddra.org Toll Free International: +1.877.258.8280 Direct: +1 703.556.2950 Fax: +1 703.556.1744

MSSO MedDRA Training By Elizabeth Thomas Training Coordinator

As with the rest of the new MedDRA website, the training page has a fresh new look and is simplified with four Training subheadings. The following article will take you through all the available features. Please explore the new training pages on the MedDRA website.

Training Page Button

Offerings: Basic information on the types of training available, i.e. Face-to-Face training, Webinars, Training videocasts, and ICH Global face-to-face training can be found here. Information regarding Fee-based on-site training is also provided.

Schedule: Lists the current Face-to-Face Training and Webinars scheduled events. By selecting either the Face-to-Face or Webinars buttons you will be shown the listing for each category (see Face-to-Face listing below). Each class or webinar event “button” takes you to the details of that specific event: title, date, venue address, course objective, description, and who should attend (see Webinar listing below).

Course listing and selecting a specific class event

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Offerings Schedule Training Materials MSSO Trainers

Face-to-face listing

Class Event Button

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MSSO MedDRA Training

Webinar listing and selecting a specific webinar event

Each class/event page has its own registration form to fill in and submit. The registration form also informs the viewer of seat availability for that specific session (see Training event information below). A confirmation email is automatically generated once you click the “Register” button. Upon registration you are also informed of any paired sessions to the one for which you just registered. No more missed learning opportunities for associated topics!

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Webinar Event Button

Webinar listing

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MSSO MedDRA Training

Training Event Information and Registration Form

If a session is full, individuals can request to be added to the waiting list by filling in the information and clicking on the “Sign up to waiting list” button, as shown below.

Remember, the free sessions are for current MedDRA subscribers only. Your training registration will not be accepted if your subscription has expired.

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Registration form

Trainer information

Seat availability

Who should attend

MSSO MedDRA Training

Add to Waiting List

Training Materials: This subheading provides a listing of and access to MSSO MedDRA videocasts and training materials by subject matter, as shown below.

For example, if you were interested to view some basic information on MedDRA you would select the General/Basics category where there are currently two presentations and three videocasts available (see General/Basics Training below ).

PDF files of course slides and presentations from User Group meetings that the MSSO considers to be useful for training are found on this page.

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Add to Waiting List form

Seat availability

MSSO MedDRA Training

Training Materials

MSSO Training materials and videocasts available under the General/Basics heading

MSSO Trainers: Select this page to view MSSO instructors’ biographical sketches. Additionally, each class has a link to the instructor’s information for that class.

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Coming Soon for MedDRA Training

Look out for two new items coming soon to the Training section of the MedDRA website:

Getting Started with MedDRA videocast

Is your organization getting ready to implement MedDRA? This videocast will provide a general overview of all you need to know to start using the terminology effectively. It will describe how ICH has developed MedDRA as a standardized international terminology for use in the monitoring of medical products through all phases of the clinical development cycle. Practical topics for implementation will also be covered: training, coding and data retrieval conventions, procedures documentation, legacy data conversion, and IT considerations. Finally, there will be a summary of the many resources available to MedDRA users including the new MedDRA website, the Help Desk, and User Group meetings.

The same “Getting Started with MedDRA” concept will be expanded into a half-day course in the near future. Please watch out on the MedDRA website for an announcement and further details about this new offering.

Training Curriculum

If you will be attending any of the MSSO’s face-to-face MedDRA training courses, the training curriculum is designed to help you take full advantage of the experience. The curriculum is a short list of introductory videocasts that the MSSO recommends that you view before coming to the classes. There will also be an optional online quiz to test your understanding of basic MedDRA principles after you have completed the series of videocasts. When you do attend the face-to-face courses, you will be well prepared with essential background knowledge and you will be able to engage fully in the interactive exercises and the discussions with the instructor and other attendees that are the most valuable parts of the “live” classroom experience.

By Judy Harrison, MD Chief Medical Officer

MedDRA Information Day Focusing on Medication Errors

The MSSO will be participating in the EMA’s 1st MedDRA Information Day on 22 October 2013 hosted by the European Medicines Agency in London, UK. This Information Day will focus specifically on the use of MedDRA for coding and retrieving adverse reactions and events occurring in the context of medication errors. Specific examples and MedDRA best practice coding principles will be discussed by experts from regulators, the MSSO, and pharmaceutical industry. The use of MedDRA in the context of EudraVigilance and other international databases will also be addressed. For more information and to register please visit the DIA website and search for event code 13542.

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