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

2

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

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

• f 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
• n 19 April 2020 affect your organization? How

could the MSSO make this easier?

• How would you handle an off-cycle release that
• ccurred 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
• rganization 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

• r 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

• wn 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
• rganization 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!