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SELECTBIO Conferences Quality, Compliance & Audit in Clinical Trials

Quality, Compliance & Audit in Clinical Trials Submission Guidelines



Submit an Abstract


If you would like to submit a proposal for an oral or poster presentation at this meeting, please click the 'submit abstract' button to view the information required for your submission.

When ready just return to this page and fill out the form accordingly.

All abstracts will be reviewed by the Scientific Advisory Board and applicants will be notified of the result in due course.

Successful applicants will be provided with all necessary information.

Abstract Content:

  • Written in English
  • Written in the third person
  • Include title, name(s) and affiliation(s) of the authors
  • Between 100 - 200 words
  • Suitable for direct publication in the proceedings pack and on the website
  • Related to the subject of the conference

Agenda Topics

  • Bioethics and Regulatory Compliance
  • CRO-Sponsor Collaboration: Expectations and Challenges
  • eCTD with CDISC: Regulatory Requirements
  • GCP/GLP & Other Requirements for CT/BE Studies
  • IT Compliance – 21 CFR Part 11
  • Management of Regulatory Audits
  • Panel Discussion Topics:
    • Data Fraud in Clinical Research: Detection, Prevention and its Solution
    • Overcoming Challenges of Volunteer Cross Participation
  • Quality Assurance Programme in Clinical Studies
  • Risk Mitigation Programme in CRO
  • Root Cause Investigation of Data Integrity Issues
  • Software Validation/Qualification in CT Studies
  • USFDA Warning Letters – How to Respond?

Copyrights

The presenting author/person who submitted the abstract assumes full responsibility of the content of the abstract and we assume that all co-authors are aware of this content. Please note that your biography, summary and abstract may be used on this website and conference materials.