Course offering number:0903-705
Course ID:
2272
Clinical Testing Submissions
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Carl A. Rockburne, Regulatory Consultant
Carl Rockburne is a regulatory consultant with extensive experience in the electronic IND (and other filings) systems. He has been involved in
the field of system validation. Additionally, he was a full time consultant to GE Healthcare Fast Trak BioDefense program. A program designed
to be a free standing entrepreneurial program within GE Healthcare.
Mr. Rockburne has also worked with small/ medium research & development companies in their search for vaccines for, including, small pox,
avian influenza, Ebola, rift valley, botulinum. Mr. Rockburne is a Certified Regulatory Compliance Auditor to the biomedical industries. (Part 11;
GMP; GLP; GCP etc. He is an expert on international clinical testing requirements, and has authored the international filings chapter for the
Guidebook to Drug Regulatory Submissions, summarizing the requirements of Canada, Australia, Japan and the EMEA.
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