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The WHODrug B3 / C3 Formats and CDISC SDTM Requirements


The WHODrug B3 / C3 Formats and CDISC SDTM Requirements, a perfect match approved by regulators

April, 2019

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.


What are the benefits

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 instructors 

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.

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.


Earn CEUs

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 assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.

Webinar Registration

Individual registration: $360 member / $420 non-member
Group registration (max. 10 people per group): $960 member / $1140 non-member

Group Registration Policy: Any group registration allows up to 10 people to attend the webinar and to complete the webinar assessment. Credits will be granted on an individual basis upon successful completion of the assessment by the registered participants.