MedDRA Update. MedDRA Industry User Group Meeting. 28 September 2018

Transcription

1 MedDRA Update MedDRA Industry User Group Meeting 28 September 2018

2 Topics MedDRA Users Profile MedDRA Translations MSSO Distribution List Opt-In Retrieving MedDRA Unzip Passwords Device terms in MedDRA Points to Consider Update Patient-Friendly Term List MedDRA Versioning in Clinical Trials MedDRA Training Update on MedDRA IT Tools 2

3 MedDRA Users Profile As of August ,500 Subscribing organizations (MSSO+JMO) 126 Countries Graph shows types of subscribing organizations 3

4 MedDRA Users by Region and Top 25 Countries 4

5 2018 MedDRA Subscription Rate Table 77% of all MedDRA users pay no fee or $688 (or less) 5

6 MedDRA Translations

7 MedDRA Translations Currently MedDRA is available in 11 languages Chinese, Czech, Dutch, English, French, German, Hungarian, Italian, Japanese, Portuguese and Spanish Translation includes all terms and documentation Currently working on Korean and Russian Release dates for the new languages are to be determined 7

8 Japanese Translation Fee Removed Effective 1 January 2019, additional $850 subscription fee for the Japanese translation of MedDRA will be eliminated MSSO subscribers will receive all MedDRA languages with their subscription at no additional cost 8

9 MedDRA Distribution List Opt-In

10 MSSO Distribution List Opt-In EU General Data Protection Regulation (GDPR) Provisions and requirements to protect personal data To be compliant with GDPR, the MSSO will ask MedDRA users to opt-in to its distribution list You will receive an asking if you wish to remain on the MSSO distribution list Default is your will be removed from the list if you do not respond You may ask to be added to the list at any time See Contact page on MedDRA website 10

11 Retrieving MedDRA Unzip Passwords Using Self-Service Application (SSA)

12 Retrieving Unzip Passwords Using SSA Previously, unzip passwords were distributed via broadcast announcing the MedDRA release

13 Retrieving Unzip Passwords Using SSA (cont) Beginning with v21.1, unzip passwords no longer distributed in the release announcement Unzip passwords stored in Self-Service Application (SSA) Can be retrieved by MedDRA Point of Contact (POC) Reasons for change More secure method to distribute password Gives POCs access even if they don t receive broadcast s 13

14 Retrieve Unzip Passwords via SSA (cont) Videocast on MedDRA website gives step by step instructions on how to retrieve unzip password: Under Tools section 14

15 Device Terms in MedDRA and IMDRF

16 Device Terms in MedDRA Device specific terms included from the inception of MedDRA More added to support combination products Device names/components are out of scope Other device-related terms In Surgical and medical procedures Drug delivery device implantation In Social circumstances Cardiac assistance device user 16

17 IMDRF and MedDRA International Medical Device Regulatory Forum (IMDRF) Developing set of harmonized terminologies for reporting adverse events for medical devices One of the terminologies being developed to describe Patient Problems IMDRF has posted a draft term list and structure for comment Comment period open until 12 October

18 IMDRF and MedDRA (cont) Annex E: Health Effects Clinical Signs, Symptoms and Conditions Terms and Codes Draft term list includes ~700 terms Provides terminology to describe the observed condition of the affected persons after the medical device adverse event occurs Terms are largely based on a subset of MedDRA terms For those organizations involved with devices or combination products you can provide feedback asp 18

19 Update on Points to Consider (PtC) Documents

20 PtC Updates v21.1 Minor changes to examples in Term Selection document Drug diversion Product quality Membership lists removed from Term Selection and Data Retrieval and Presentation documents Available on ICH website 20

21 PtC Documents Current and New 21

22 PtC Companion Document 22

23 Patient-Friendly Term List

24 Patient-Friendly Term List MSSO and partner organizations developed a patient-friendly term list Sub-set of MedDRA Lowest Level Terms in English Derived from adverse events reported by patients and consumers in several pharmacovigilance databases 24

25 Use of Patient-Friendly Terms For adverse event reporting websites and mobile applications intended for patients and consumers Allows direct reporting using terms that are already in MedDRA No need for additional coding into MedDRA Immediately available for analysis List is used in YellowCard online form for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK 25

26 List Available for Download Link on Support Documentation page on MedDRA website Spreadsheet of LLT names and codes 1,440 terms in v21.1 Maintained by MSSO with each MedDRA release 26

27 Patient-Friendly Term List v

28 Patient-Friendly Term List Statistics 28

29 Patient-Friendly Term List Statistics (cont) 29

30 Use of Patient-Friendly Terms How do you use the Patient-Friendly Term List? Any insight into how it is being used in countries where English is not the primary language? 30

31 MedDRA Versioning in Clinical Trials

32 Versioning in Clinical Trials Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 32

33 Versioning in Clinical Trials (cont) Generally, the studies included in a submission are conducted over many years and may have used different MedDRA versions to code adverse events. The expectation is that sponsors or applicants will use the most current version of MedDRA at the time of study start. However, there is no requirement to recode earlier studies. The transition date for support and requirement to use the most current version of MedDRA is March 15, Although the use of the most current version is supported as of this Federal Register notice and sponsors or applicants are encouraged to begin using it, the use of the most current version will only be required in submissions for studies that start after March 15, The Catalog will list March 15, 2019, as the date requirement begins. 33

34 MedDRA Training

35 MSSO Free Training Program Formats Face-to-face sessions, webinars, videocasts, YouTube Channel Languages English, French, German, Spanish, Mandarin Chinese Locations Worldwide and virtual 35

36 Face to Face Training Session Titles Coding with MedDRA Safety Data Analysis and Standardised MedDRA Queries (SMQs) Getting Started with MedDRA 36

37 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 37

38 Face to Face Training Tab 38

39 Webinar Training Tab 39

40 Update on MedDRA IT Tools

41 Major Web-Based Browser 3.0 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 Expected by Q MedDRA Desktop Browser update will follow 41

42 Browser Supplemental View Change View to Supplementals Supplemental changes highlighted Display changes color and adds labels for supplemental view 42

43 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 43

44 WBB 3.0 Secondary SOC Information Option to extract Secondary SOC* information: Exporting from the research bin Separate feature to upload MedDRA terms and extract hierarchy information Optional Secondary SOC hierarchy *Primary SOC is the default 44

45 WBB 3.0 Secondary SOC Information (cont) Example export with Secondary SOC information* *Primary SOC hierarchy information is included by default 45

46 SMQ Analysis Purpose assist MedDRA users in applying SMQs to their coded data Input: 46

47 SMQ Analysis (cont) 47

48 SMQ Analysis (cont) Output: 48

49 Planned MVAT 3.0 Updates Ability to run reports on supplemental changes Option to include secondary SOC changes Expected before the end of

50 Future Plans 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 or not available due to constraints of the mobile platform For example, features that require import and export of data Expected in

51 Future Plans (cont) 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 in 2019 Thoughts on required level of verification and validation? 51

52 Application Program Interfaces - Examples Data: List of MedDRA Terms Request: SMQ Analysis Input API Outputs List of SMQ matches per the inputted term list Data: List of MedDRA Terms Request: MedDRA hierarchy Input API Outputs MedDRA primary & Secondary SOC hierarchy information The user does not need to know how to apply the input data against MedDRA 52

53 Thank You Questions?