Mr. SHAFQAT HUSSAIN DANISH

About

1. Good Clinical Practice (GCP) Oversight
He is responsible for managing the review and revision of DRAP’s GCP inspection guidelines, and coordinates public consultations for these important regulatory updates
2. Clinical Trial Approvals & Monitoring
As secretary of DRAP’s Clinical Study Committee, he signs off on major clinical trial approvals—such as COVID 19 vaccine trials—and ensures oversight by the National Data Safety Monitoring Committee.
3. Regulatory Framework for Clinical Research
He plays a key role in drafting and implementing guidelines related to trial amendments, recalls, rapid alerts, and related safety measures for therapeutic goods
• Role: Deputy Director, Clinical Research (also Secretary to the Clinical Study Committee).
• Expertise: GCP inspections, clinical-trial approvals & regulatory governance, safety monitoring guidelines, and therapeutic goods regulation.

Areas of Expertise