WHODrug Webinar

Home » WHODrug Webinar

The WHODrug B3 and C3 formats and CDISC SDTM requirements, a perfect match approved by regulators

April 24, 2019

08:00 AM EDT and 11:00 AM EDT

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 has UMC 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 OF THIS WEBINAR

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.

COURSE REGISTRATION

$360 members/$420 non-members
Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the course start date. If cancellation occurs by the end of week one of the course, students will be allowed to apply 50% of the course fee to the next offering of the same course. No refunds will be offered after that time.