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Joyce Hauze
Associate Director, Clinical Trial Disclosure and Transparency at Mallinckrodt Pharmaceuticals, USA

Profile

Joyce Hauze is an ACRP-certified clinical research associate and project manager, with her bachelor’s in Experimental Psychology (Pharmacology), and graduate studies in Neuro-psychopharmacology.

During her 44-year career, she has:

  • served as facility manager for a PHS Small Business Innovation Research Grant to develop an antisense strategy to inhibit formation of 5HT2 receptors in the rat brain;
  • served as preclinical facility manager and principal investigator, then clinical study manager;
  • authored grant proposals, manuscripts, protocols, informed consent/assent documents, lay summary templates and guidelines, investigator brochures, clinical development plans, and clinical sections of INDs;
  • audited clinical study reports and trial master files; and
  • held increasingly responsible roles in intellectual property law, clinical operations, quality assurance, regulatory intelligence, and clinical trial disclosure and transparency.

Joyce currently is a member of the DIA Clinical Trial Disclosure Community and serves on the CDISC Protocol Entities Working Group.

Agenda Sessions

  • Challenges of Writing Disclosure-Friendly Documents Up-front for Submission in the CTIS

    8:40am
  • PANEL: Preparedness for CTIS – Are you ready?

    10:20am