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RBQM in CDM - Getting ready for targeted querying?

RBQM in CDM - Getting ready for targeted querying?

Date: December 16, 2021
Time: 07:00 AM PDT | 10:00 AM EDT | 16:00 CET | 19:30 IST

OVERVIEW;

Over the past years, regulators & ICH have been encouraging us to implement the principles of risk-based quality management. 100% quality does not exist; focus where it matters most. Clinical Data Management developed a very accurate data capture process - to which the back-end query process hardly adds any value. In addition, we have been developing many indicators that provide more or less real-time information on the data collection process, and that allow us to act & mitigate risks as soon as they are detected.

In this new context there is an opportunity to greatly improve CDMs efficiency & to reduce the burden on the sites by embarking on targeted querying. Are we ready for it?

WHAT YOU'LL LEARN 

  • The Regulatory background of RBQM in clinical development and its implementation
  • How the optimal implementation of RBQM will connect and integrate the various functions involved in the design & conduct of clinical studies
  • How the availability of the right risk indicators is supporting an ongoing risk management process resulting in a continuous improvement of data quality & process efficacy
  • How RBQM can strongly increase the efficiency of Clinical Data Management by helping the data managers focus on where it matters most

WHO SHOULD ATTEND

The audience should have a basic understanding of Clinical Data Management and be able to follow the reasoning that in this day & age the 100% backend query process may have lost parts of it's relevance, considering the proactive approaches we have been developing to manage quality in clinical develop - including data quality.

WHAT ARE THE BENEFITS 

Participants may be able to lead or support changes in their departments that may
usher Clinical Data Management into a new era.

MEET THE PRESENTER

Peter Stokman, Business Lead Data Review & Visualization, Bayer
Joined Bayer Pharma in 2017 as Business Lead for the Data Review and Visualization Environment. Wide experience in Drug Development in Europe and the US: Director Regulatory Affairs, Clinical Research Scientist, Project Director Compound Development, Senior Director Clinical Data Management at Organon, Schering-Plough, MSD. Passion for change management. Member of the Society for Clinical Data Management (SCDM) Board of Trustees, chair of the SCDM EMEA Steering Committee.

WEBINAR REGISTRATION

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.

Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the webinar date. If cancellation occurs within the week prior the webinar, participants will be allowed to apply 50% of the webinar fee to the next offering of the same webinar. No refunds will be offered after that time.

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