ON-DEMAND WEBINAR · 2019
The WHODrug B3 / C3 Formats and CDISC SDTM Requirements, a perfect match approved by regulators
- Session Overview: In March 2017, The Uppsala Monitoring Centre introduced the WHODrug B3/C3 formats, not only to facilitate CDISC SDTM compliance, but also to improve the usability of the concomitant medication information collected in clinical trials for both WHODrug users and regulators.
Overview
In March 2017, The Uppsala Monitoring Centre introduced the WHODrug B3/C3 formats, not only to facilitate CDISC SDTM compliance, but also to improve the usability of the concomitant medication information collected in clinical trials for both WHODrug users and regulators. Shortly after, in October 2017, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register, stating that the use of the B3-format of WHODrug Global will be required in submissions for studies starting after March 15, 2019. The U.S. FDA Data Standards Catalog has also been updated with this information.
Since March 1st 2017, the UMC has distributed the B2/C formats in parallel with the B3/C3 formats to facilitate smoother implementation for WHODrug users. This transition period now comes to an end on March 1st 2019, when the B3 format will finally replace the B2 format, and the C3 format will finally replace the C format.
What You'll Learn
- Understand why UMC has introduced the B3- and C3-formats
- List the current regulatory requirements applicable to the use of WHODrug Global and the B3- and C3-formats
- Describe the technical differences between the WHODrug B3- and C3-formats and the old B2- and C-formats
- List the benefits of using the WHODrug B3- and C3-formats when submitting data that must meet the CDISC SDTM requirements
- Describe resources available to smoothly implement the WHODrug B3- and C3-formats
Who Should Attend
Attendees should have a basic understanding of the content and structure of WHODrug. The level of the webinar is intermediate.
This webinar will provide the attendees with knowledge about technical aspects of the WHODrug B3- and C3-formats; the current regulatory requirements applying to WHODrug data, and with knowledge about the resources available to smoothly and successfully implement the WHODrug B3- and C3-formats.
Meet the Speaker
Marilina Castellano
MSc Pharm
Terminology Specialist, WHODrug & Terminologies, UMC
Marilina has a master’s degree in pharmacy and a Postgraduate Diploma in Pharmacovigilance. She works at UMC in the maintenance of WHODrug data. Her responsibilities include the provision of quality and efficient WHODrug support and training.
Terminology Specialist, WHODrug & Terminologies, UMC
Anna Siemiatkowska
MSc Pharm
Terminology Specialist, WHODrug & Terminologies, UMC
Anna has a bachelor’s degree in nursing and a master’s in pharmacy. She works at UMC in the maintenance of WHODrug data. Her responsibilities include WHODrug Support, WHODrug Training and some work with MedDRA.
Terminology Specialist, WHODrug & Terminologies, UMC
Earn CEUs
SCDM is authorized by IACET to offer 0.2 CEUs for this education program. Participants are eligible to receive CEUs upon successful completion of the digital assessment questionnaire linked to this session, within 30 days after the purchase of the conference session.
Price
SCDM members: $50
Non-members: $175
Not yet an SCDM member? Purchase this conference session and get a one-year membership with SCDM on us to enjoy all our educational programs and sessions at a discounted price.
Need support?
Technical support:
Click on the help button on the bottom right, select contact support and email the BlueSky team with any technical issues. Otherwise e-mail directly to support@blueskyelearn.com or call +1-888-705-6002 for immediate help.
The SCDM Learning team is here to help. Contact us at learning@scdm.org or call +32 232 024 87.