What s New with MedDRA Version 18.1 and the MSSO David W. Richardson, M.D. Medical Officer, MedDRA MSSO 3 & 10 September 2015 MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The activities of the MedDRA Maintenance and Support Services Organization (MSSO) are overseen by an ICH MedDRA Management Board, which is composed of the six ICH parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, Health Canada, and the WHO (as Observer) 2 1
Disclaimer and Copyright Notice This presentation is protected by copyright and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the presentation is acknowledged at all times. In case of any adaption, modification or translation of the presentation, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original presentation. Any impression that the adaption, modification or translation of the original presentation is endorsed or sponsored by the ICH must be avoided. The presentation is provided "as is" without warranty of any kind. In no event shall the ICH or the authors of the original presentation be liable for any claim, damages or other liability arising from the use of the presentation. The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder. 3 Topics What s New with Version 18.1 Summary of changes (including SMQs) Proactive Maintenance Update on Points to Consider Documents Update on SOC Product issues Update on MedDRA IT Tools MedDRA Training Upcoming Meetings 4 2
What's New with MedDRA Version 18.1 MedDRA Version 18.1 Released on 1 September 2015 A simple release Change request summary: MSSO considered 1,799 change requests, including SMQ requests (not including translation updates) Approved: 1,323 Rejected: 431 Suspended: 45 6 3
Net Change of Terms per SOC (Reflect differences from v18.0 to v18.1) Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders General disorders and administration site conditions Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl Nervous system disorders Pregnancy, puerperium and perinatal conditions Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Social circumstances Surgical and medical procedures Vascular disorders 8 12 19 37 27 38 28 32 27 28 44 51 61 62 56 59 57 68 81 89 93 113 135 138 164 195 7 Version Report List of various types of changes in MedDRA 8 4
Summary of SMQ Changes No new SMQs were added 98 SMQs in current release 292 PT changes made to existing SMQs SMQ PT Source Embolic and thrombotic events, venous Jugular vein occlusion New PT Hypersensitivity Shock symptom Promoted PT Lens disorders Lenticular operation Existing PT 9 Proactive Maintenance 5
Proactivity Request Hemorrhage and Hematoma terms Reviewed primary SOC allocation for hemorrhage and hematoma PTs to ensure consistency Primary SOCs of these terms were changed based on the site of manifestation or cause (i.e., injury) A total of 19 changes were made PT Name 18.0 Primary SOC 18.1 Primary SOC Adrenal haematoma Injury, poisoning and procedural complications Endocrine disorders Intra-abdominal haematoma Umbilical haematoma Vascular disorders Congenital, familial and genetic disorders Gastrointestinal disorders Skin and subcutaneous tissue disorders 11 Proactivity Request Placement of tinea concepts Reviewed the placement of tinea concepts for better and more accurate placement There were LLTs under tinea PTs which did not indicate tinea (they were more general in nature) A total of 10 changes were made LLT Name 18.0 PT 18.1 PT Foot infection fungal NOS Tinea pedis Fungal skin infection Fungus foot Tinea pedis Fungal skin infection Ringworm of nail Onychomycosis Dermatophytosis of nail 12 6
Update on Points to Consider Documents Points to Consider Documents Updated documents based on MedDRA Version 18.1 available on 1 September 2015 MedDRA and JMO websites Word ( clean and redlined ), PDF, HTML formats Summary of Changes documents replaced by redlined copies of PtC documents Identify changes made from previous to current release of documents Easier to copy and paste changes into internal user documentation 14 7
Redlined PtC Documents 15 Redlined MTS:PTC 16 8
Update on SOC Product issues SOC Product issues ICH MedDRA Management Board endorsed creation of a new (27 th ) SOC for implementation in MedDRA Version 19.0 Includes terms relevant for issues with Product quality Devices Manufacturing and quality systems Supply and distribution Counterfeit products Expert Working Group provided input on structure and contents Representatives from regulatory authorities, industry, MSSO, JMO Expertise in MedDRA and product quality 18 9
SOC Product issues Timeline 19 Complex Change Proposals HLGT Product quality, supply, distribution, manufacturing and quality system issues HLT Counterfeit, falsified and substandard products HLT Manufacturing facilities and equipment issues HLT Manufacturing issues NEC HLT Manufacturing laboratory controls issues HLT Manufacturing materials issues HLT Manufacturing production issues HLT Product contamination and sterility issues HLT Product distribution and storage issues HLT Product label issues HLT Product packaging issues HLT Product physical issues HLT Product quality issues NEC HLT Product supply and availability issues New Existing (moved from General disorders SOC) 20 10
Complex Change Proposals (cont) HLGT Device issues HLT Device computer issues HLT Device electrical issues HLT Device incompatibility issues HLT Device information output issues HLT Device issues NEC HLT Device malfunction events NEC HLT Device operational issues NEC HLT Device physical property and chemical issues Existing (moved from General disorders SOC) All complex changes posted on Change Requests page on MedDRA website The MSSO encourages your feedback by 25 September 2015 21 Update on MedDRA IT Tools 11
MedDRA Version Analysis Tool (MVAT) 2.0 User interface available in all MedDRA languages Report output available in all MedDRA languages An improved history function An option to filter report output by SOC Improved report output related to MedDRA and SMQ changes 23 MVAT 2.0 SOC Filter Feature Ability to filter version reports by SOC 24 12
MVAT 2.0 French Interface and Report Output 25 MVAT 2.0 History Feature Graphical display of history Narrative description of the change at top of each version change box Term highlighted 26 13
MedDRA Desktop Browser Will be updated to match new features added to Web-Based Browser (WBB) New search algorithm Change to a single line entry for searches Search result categories Exact match, Lexical variant, Synonym search, Contains search Research bin import function 27 New Features* MedDRA Desktop Browser (cont) Language specific interface Display term hierarchy when exporting search results and Research Bin Export search results and Research Bin contents in multiple languages Export SMQs in multiple languages Scheduled release in Fall 2015 *These features will be added to next version of WBB 28 14
MedDRA Desktop Browser Screenshot 29 MedDRA Desktop Browser Screenshot (cont) 30 15
MedDRA User Interface Language Selection 31 MedDRA Desktop Browser Research bin with hierarchy information Primary SOC hierarchy of terms exported from the research bin 32 16
MedDRA Training MSSO Free Training Program Formats Face-to-face sessions, webinars, videocasts Languages English, French, German, Spanish, Mandarin Chinese Locations US, Europe, Asia, and virtual 34 17
Changes to MedDRA Webinars Current webinars will be updated Length will be cut to maximum of 60 minutes Webinars will be organized into modules (i.e., coding, data analysis, SMQs, etc.) Modules will contain courses of different levels (e.g., basic and advanced courses) Webinars will be more interactive (i.e., use of video, greater use of browser demonstrations, polling questions) Changes to be made by early 2016 35 Developer Webinar Objective Information on new MedDRA initiatives impacting IT systems Feedback on how to make MedDRA easier to use for developers Designed for system developers, IT staff Topics to include Implementation of new SOC Product issues Secondary SOC views Supporting split coding SMQ support Application programming interfaces (APIs) Cloud distribution of MedDRA Scheduled for October 2015 36 18
Host for Free Training? MSSO is seeking locations to host free training Could be at regulator or company site Host can send 5 attendees Qualifications A conference room for 25-30 people A projector and a screen Please contact MSSO Help Desk if you are interested in hosting training mssohelp@meddra.org 37 Upcoming Meetings 19
US Industry MedDRA User Group Meeting When: Friday, 18 September 2015 US Industry User Group meeting hosted by Procter & Gamble 2 Procter & Gamble Plaza Cincinnati, Ohio 45202 MSSO will attend See User Group page on MedDRA website for agenda 39 European Industry MedDRA User Group Webinar Topic: Medication Error Coding When: Tuesday, 13 October 2015 14:30 16:00 CET / 8:30 10:00 US EST Features speakers from EMA, FDA and Industry Open to all MedDRA users See User Group page on MedDRA website for registration and agenda 40 20
Thank You Questions? David W. Richardson, M.D. Email: mssohelp@meddra.org 21