Joyce HauzeAssociate 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
, 8:40amView SessionPANEL: Preparedness for CTIS – Are you ready?
, 10:20amView Session