MedDRA and Information Technology Blue Ribbon Panel Discussion - PowerPoint PPT Presentation

MedDRA and Information Technology Blue Ribbon Panel Discussion 10-Sep-2020

Blue Ribbon Panel Agenda Time (EST) Topic 10:00-10:10 Opening and Introductions 10:10-10:45 MedDRA Dictionary Release Process 10:45-11:20 Use of Artificial Intelligence/Machine Learning/ Natural Language Processing with MedDRA 11:20-11:55 MedDRA Application Programming Interface Quality Requirements 11:55-12:00 Closing Remarks 2

Blue Ribbon Panel

What is a Blue Ribbon Panel? • Provides a forum for MedDRA experts to make recommendations on challenging MedDRA issues • Panelists include experts from a broad spectrum including regulatory authorities and life science industry • Observers play an important role • Panel produces recommendations for MedDRA Management Committee consideration 4

This Blue Ribbon Panel • MedDRA Management Committee (MMC) requested independent IT consultant review of MSSO Technology and Platforms in 2019 • Project began in Q1 2020 • Project includes incorporating feedback from MedDRA community – Community survey (conducted June/July 2020) – Blue Ribbon Panel of experts (September 2020) 5

Introductions

Blue Ribbon Panel Team Panel Members • – Henry Chen, Principal, Thesaurus Information and Strategies, Inc. – Suranjan De, Deputy Director, Regulatory Science, FDA OSE, CDER – Nick Halsey, EMA Data Analytics and Methods Task Force - Healthcare Data – Kostas Kidos, VP, Head PV Services, Takeda – Sameer Thapar, Director of Global Pharmacovigilance, Oracle Panel Facilitator • – Brian K. Perry, President, BKP Technologies, Inc. MSSO Facilitators • – Brian J. O’Hare, Manager, MedDRA Terminology and Maintenance – Patrick Revelle, MSSO Director – Liz Thomas, Training Coordinator 7

Discussion Topics

MedDRA Dictionary Release Process

MedDRA 23.0 Re- Release • On 19 April 2020 the MSSO re-released the MedDRA 23.0 dictionary with updates for the global COVID-19 pandemic • This “off cycle” release was not expected or included in the release plans for the MSSO • More information about COVID-19 and the off- cycle release is available at: – https://www.meddra.org/COVID-19-terms-and- MedDRA 10

Off Cycle Releases • How did the off-cycle release of MedDRA 23.0 on 19 April 2020 affect your organization? How could the MSSO make this easier? • How would you handle an off-cycle release that occurred after the global transition date? • How would you like to see off-cycle releases numbered? What would be the impact of a numbering change? 11

Release Frequency • Should the MSSO consider a different release schedule for the MedDRA dictionary? • What release frequency would be of most use to your organization? • What would be the use case(s) for a different release schedule? • What would be the challenges your organization would face implementing a different release schedule? 12

Observer Q&A

Use of Artificial Intelligence/Machine Learning/ Natural Language Processing with MedDRA

Artificial Intelligence (AI) • Machine Learning (ML) and Natural Language Processing (NLP) appear on the top of any trend or list of technology influences • Recent advances in computing technology hardware and software algorithms and techniques have brought AI ML/NLP to new levels of sophistication and utility • Organizations are looking to leverage these technologies within their businesses 15

ML & NLP With MedDRA • What do you see as the use cases and applications for using technologies such as ML and NLP with MedDRA both within your own organization and within the MSSO? • What are some potential risks with using ML/NLP with MedDRA? – How can the risks be mitigated? 16

MSSO Assistance with ML/NLP for MedDRA – Best Practices White Papers – Training and Education – Review and Certification Program – Implement ML/NLP in MSSO web tools – Other ML/NLP tools/APIs for members to use or incorporate into their own software/services – Dictionary products such as natural language synonym lists 17

Observer Q&A

MedDRA Application Programming Interfaces (APIs)

MedDRA APIs • The MSSO has developed a set of MedDRA Application Program Interfaces (APIs) in response to user requests • The APIs are an open software model which users can use to develop their own MedDRA tools, or extend existing tools • MedDRA API Schedule: – February 2020 – APIs available for testing and feedback – February-August 2020, the MSSO engaged MedDRA users to seek feedback and to refine the APIs – October 2020 - Final refinement and deployment for production use 20

MedDRA APIs • What are some of the challenges your organization might experience in implementing the MedDRA APIs within your validated systems? • What types of assistance can the MSSO provide to the community to facilitate the use of the APIs in a fully validated computer system? 21

API Service Levels • What service levels, such as availability, validation support, documentation, and/or technical support are necessary for the MSSO to meet your organizations needs and requirements? 22

MedDRA APIs • More detailed information on the APIs is available at: – https://admin.new.meddra.org/sites/default/files /page/documents/MedDRA_API_Information.zip 23

Observer Q&A

Closing Remarks

Thank you! The MSSO would like to thank our Panelists and Observers!