ONLINE WEBINAR · November 8, 2022, 08:00 AM PDT | 11:00 AM EST | 17:00 CET | 21:30 IST
MedDRA Training for Data Managers and Associate Roles: What is MedDRA and the MSSO?
Session Overview: This three-part webinar series will provide a comprehensive and practical overview of what MedDRA is and how it is used.
OverviewThis webinar is part of a series of three one-hour webinars followed by a Q&A session.
The webinar series will provide a comprehensive and practical overview of what MedDRA is and how it is used. Training is intended for Data Managers and associated roles, not to teach specialist coders how to code.
Each module will comprise:
- Knowledge topics
- Demonstration with examples
- Signpost to guidelines, supporting resources and references
- Guidance on handling coding related challenges and questions
Webinar 1 - What is MedDRA and the MSSO? on November 8, 2022
- MedDRA history and purpose
- Governance of MedDRA
- Role of the MSSO and subscription services
- MedDRA structure and scope
- Requesting changes to MedDRA
- Interoperability with other terminologies
- Role of MedDRA in Clinical trials and Pharmacovigilance
Webinar 2 - How is MedDRA used for coding? on November 15, 2022
Webinar 3 - How is MedDRA used for analysis? on November 22, 2022
You can attend one or several of the webinars in this series. Participants who wish to attend the entire series of three webinars will receive a 25% discount on the total price of the webinars. Please contact email@example.com if you wish to attend the three webinars, and we will provide you with your discount code.
What You'll Learn
- 1. Understand the background, structure and scope of MedDRA and its importance in the collection, analysis and presentation of safety data.
- 2. Justify decisions that relate to coding and dictionary management, with reference to Best Practice documentation and ICH-endorsed guidelines.
- 3. Have awareness of the tools and services provided as part of a MedDRA subscription, enabling contribution to strategic discussions about the practical use of MedDRA for coding and analysis.
- 4. Assess the impact of MedDRA version upgrades on clinical trials and advise on the optimum approach with consideration of timing, resources and data quality.
Who Should AttendData managers at all levels and associated roles, wishing to enhance their awareness of MedDRA and coding-related best practice. Any roles seeking an overview of MedDRA purpose and application, using related tools and documentation, for both coding and data analysis. Training is not intended to teach designated coders how to code.
Meet the Speaker
Clinical Associate, MSSOJane is a qualified General Nurse and holds an undergraduate degree in Social Psychology and postgraduate degrees in Health Psychology and Digital Education.
She gained industry experience of using MedDRA as part of her role as Coding Team Leader at Roche Products Limited from 1999 to 2012.
Since 2008, Jane has worked with the MedDRA Support Services Organisation (MSSO), creating and delivering a variety of training events. She is also part of the Help Desk team which provides support to MedDRA users via email and online chat.
Throughout her career, Jane has been involved in various coding-related industry groups including the European Industry MedDRA User Group and the Association for Clinical Data Management Coding & Dictionaries Special Interest Group, which she founded in 2001.
Earn CEUsSCDM is authorized by IACET to offer 0.2 CEUs for this program. Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
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