Course offering number:0811-113
Course ID:
2242
Clinical Testing Plan and Submissions – a TWO Part Course
November 6 and 11, 2008 at 11:00 a.m. - 12:30 p.m. (EST)
90 Minute Accredited Online Training
SESSION 1: Dr. Sandy Weinberg; Associate Professor, Health Care Management, Clayton State University
Dr. Sandy Weinberg, is an Associate Professor of Health Care Management (Regulation) at Clayton State
University, part of the Georgia State University System; a retired regulatory professional from the drug, device,
and vaccine industries; and a consultant with more than twenty-five years of experience. He is the author of
Guidebook to Drug Regulatory Submissions (Wiley, 2008).
SESSION 2: Carl A. Rockburne; Regulatory Consultant
Carl A. Rockburne is a regulatory consultant with extensive experience in the electronic IND (and other filings)
systems. He is also 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, the EMEA, Switzerland, and Japan.
NOTE: Both instructors will be available during both sessions to deal jointly with arising questions.
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