Introduction and Welcome. Basel, Switzerland 16 April 2018

Transcription

1 Introduction and Welcome Basel, Switzerland 16 April 2018

2 MedDRA Users Profile As of March ,200 Subscribing organizations (MSSO+JMO) 120 Countries Graph shows types of subscribing organizations 2

3 MedDRA Users by Region and Top 20 Countries 3

4 2018 MedDRA Subscription Rates Commercial 0-2 subscription rates reduced in 2018 Reduction is a reflection of the continued success of MedDRA as a global standard in public health Costs of maintaining and developing MedDRA are distributed over a wider base While still providing the same high standard of tools and services to MedDRA users In fact, expanding services to include more translation and more software tools 4

5 2018 MedDRA Subscription Rate Table 76% of all MedDRA users pay no fee or $688 (or less) 5

6 ISO Certification MSSO certified as ISO 9001:2015 compliant Internationally recognized quality management system standard Developed by the International Standards Organization (ISO) MSSO has held ISO certifications continuously since 2003 Involves: Inspection of SoPs Inspection of records to support the use of SoPs Interviews with MSSO staff to ensure understanding of processes 6

7 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 7

8 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 8

9 List Available for Download Link on Support Documentation page on MedDRA website Spreadsheet of LLT names and codes 1,440 terms in v21.0 Maintained by MSSO with each MedDRA release 9

10 List v

11 ICH M1 Points to Consider Working Group (PtC WG) Regulators and industry from EU, US, and Japan MFDS, Republic of Korea Health Canada, Canada MSSO JMO Meeting November 2017, Geneva, Switzerland 11

12 Points to Consider (PtC) Documents Available on MedDRA website MedDRA Term Selection: Points to Consider MedDRA Data Retrieval and Presentation: Points to Consider In development Points to Consider Companion Document Condensed Points to Consider Document 12

13 Points to Consider (PtC) Documents 13

14 PtC Companion Document PtC documents provide valuable guidance Term selection and data retrieval general principles Coding and analysis examples Companion document is intended to provide more information on specific topics Detailed guidance Examples Question and Answers Focus on topics of global regulatory importance 14

15 PtC Companion Document (cont) Intended as living document with frequent updates based on users needs Not tied to bi-annual PtC document releases Two topics in first edition Data quality Medication errors Planned for release in Q Available in English and Japanese 15

16 Condensed PtC Documents Update Condensed versions of PtC documents finalized To be translated into all MedDRA languages except English and Japanese Plan to make available in late 2018 English and Japanese PtC documents will remain as full documents updated with each MedDRA release 16

17 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 user documentation Currently working on Korean and Russian Release dates for the new languages are to be determined 17

18 Mapping Initiatives Regulatory and industry users interested in getting access to more sources of data MSSO is part of a consortium of regulators, industry, and maintenance organizations Funded by the Innovative Medicines Initiative (IMI) Public-private partnership between the EU and EFPIA IMI aims to boost biopharmaceutical innovation, speed up the development of better and safer medicines for patients 18

19 IMI Partners 19

20 Work Package Goals Work Package 3.1 Terminology Mapping and Maintenance Facilitate communication between regulatory and healthcare databases Establish mapping protocols and distribution agreements Delivering an initial mapping between a subset of key pharmacovigilance terms 20

21 MSSO Goals for Mapping To be provided with MedDRA subscription at no additional charge Establish a process to propose additional terms to be mapped or changes to existing mappings Regular maintenance of the mappings 21

22 Did You Know? 22

23 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 23

24 Concept Descriptions (cont) 24

25 MedDRA User Documentation MedDRA user documentation is available on the MedDRA website MedDRA Introductory Guide SMQ Introductory Guide What s New Document Distribution File Format Document No Password Needed to Access these files 25

26 MedDRA User Documents 26

27 MSSO Free Training Program Formats Face-to-face sessions, webinars, videocasts YouTube Channel with recorded videocasts and webinars (new) Languages English, French, German, Spanish, Mandarin Chinese Locations Worldwide and virtual 27

28 MedDRA MSSO YouTube Channel 28

29 MedDRA Training 29

30 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) 30

31 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 31

32 Supplemental files (cont) 32

33 Supplemental files (cont) How many use supplemental files or information? MSSO plans to include supplemental files as an option in a future WBB and MVAT update Example: 33

34 Self Service Application Available since April 2017 Provides User ID, Passwords, POC, Subscription status, Training certificates In future, this is how users will access new passwords 34

35 Self-Service Application Update (cont) Beginning with MedDRA v21.1 (September 2018), MSSO will use the Self-Service Application for: Distributing unzip passwords Obtaining password information for new subscriptions and subscription renewal Unzip passwords will not be included directly in messages This change will improve information security 35

36 Thank You Questions?