MedDRA MSSO User Group Meeting. Glasgow, UK 28 March 2017

Transcription

1 MedDRA MSSO User Group Meeting Glasgow, UK 28 March 2017

2 Discussion Topics 2

3 MedDRA Users Profile As of 31 January ,846 Subscribing organizations 101 Countries Graph shows type of organizations (self identified) 3

4 MedDRA Users by Region and Top 25 Countries 4

5 2017 MedDRA Subscription Rates All subscription rates reduced at least 9-10% 2016 Commercial 2 subscription rate now divided into two levels: New 2017 Commercial 2 rate Revenue of $10-$20 Million USD reduced 50% to $2,765 New 2017 Commercial 3 rate Revenue of $20-$500 Million USD reduced to $4,976 As of 1 January 2017, additional fee for Chinese MedDRA translation removed 5

6 2017 MedDRA Subscription Rate Table 6

7 India User Group Meetings 1 st User Group Meetings in India Mumbai (6 Feb 2017) Bangalore (9 Feb 2017) Combined with UMC for a WHODrug- MedDRA day-long meeting Well attended Over 80 attendees in each location 7

8 Unqualified Test Name Term List MSSO developed an unqualified test name term list PT Blood glucose These terms should never be reported as AEs Intended for use in E2B test name field only Standardised, complete list of test name terms is a useful tool for checking data quality Helps identify inappropriate use of terms in data fields other than test name Intended as recommendation only Maintained by MSSO with each MedDRA release Available now 8

9 List Available for Download Support Documentation page on MedDRA.org Spreadsheet of LLT/PT names and codes from Investigations SOC >3,600 terms in v19.1 Explanatory document Purpose, uses, development of list Also available in Japanese on JMO website 9

10 List v

11 MedDRA Term Selection: PtC Updates Added information about Unqualified Test Name Term List Updated references to new medication errors/product use issues hierarchy Clarification of preferred and alternative options for prevention/prophylaxis indications 11

12 Condensed PtC Documents Update PtC WG drafted condensed versions of PtC documents Now being finalized To be translated into all MedDRA languages except English and Japanese Version independent; focus on general principles Aim is to support adoption and consistent use of MedDRA worldwide Plan to make available in Q English and Japanese PtC documents will remain as full documents updated with each MedDRA release 12

13 Companion PtC Document More detailed guidance, examples, and Questions and Answers Topics of regulatory importance including: Data quality, medication errors, product quality issues Living document with updates based on users needs Available in English and Japanese only Initial version planned for release in Q

14 Patient Friendly Terms MSSO to develop a set of MedDRA terms that are patient friendly to support patient reporting through mobile apps and web portals Part of WEB-RADR project Patient friendly concept difficult to define upfront so chose a data-driven approach Terms patients have used in reports in datasets Similar terms that patients would be likely to use Review of draft list by patient stakeholders 14

15 Plan to distribute on MedDRA website LLT names and codes in spreadsheet Explanatory document For use in apps and web portals Regulatory authorities Industry Patient Friendly Terms (cont) Will be maintained with each MedDRA version Currency check of included LLTs 15

16 List Development Draft list of ~2,500 LLTs 16

17 List Development (cont) Reviewed draft list with MHRA and EMA Removed several categories of terms that are unlikely to be reported by patients Most investigation terms and technical medical terms Surgical/medical procedures, medication errors, and social circumstances terms (not AEs) Final draft ready for pilot study in Yellow Card app MHRA arranging for review by patient groups Present results to Board at June 2017 meeting Aim to make list available later in

18 Mapping Initiatives Regulatory and industry users interested in getting access to more sources of data Mappings from SNOMED CT, ICD 10/11 (and other terminologies to be determined) facilitate the transfer of data into MedDRA MSSO will participate in a new IMI initiative to develop the mechanism and framework to develop MedDRA mappings 18

19 Concept Descriptions Descriptions of how a concept is interpreted, used, and classified in MedDRA Not a definition Intended to aid accurate and consistent use of MedDRA in coding and retrieval Overcome differences in medical practice worldwide Descriptions aim to be broadly consistent with definitions across different regulatory regions See Appendix B of MedDRA Introductory Guide Accessible in MSSO s Browsers

20 Concept Descriptions (cont)

21 MSSO Free Training Program Formats Face-to-face sessions, webinars, videocasts Languages English, French, German, Spanish, Mandarin Chinese Locations Worldwide and virtual

22 Face to Face Training Session Titles Coding with MedDRA Safety Data Analysis and Standardised MedDRA Queries (SMQs)

23 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)

24 New Videocast Topic is The Top 12 Things to Know about the MedDRA website Fast paced tour of key points of the MedDRA website Available spring

25 Supplemental files MSSO posts weekly interim changes to MedDRA Purpose: Provide information on changes that will appear in the next MedDRA Version Posting includes: Weekly changes Comprehensive changes to date A PDF file describing all changes considered Sequential extended ASCII files that can be applied to non production environments 25

26 Supplemental files (cont) 26

27 Supplemental files (cont) How many use supplemental files or information? How can the MSSO make them more useful? Example: Supplemental Mode Enabled Supplemental Mode Enabled Supplemental Mode Enabled 27

28 Thank You Questions?