Dr. Joseph Kozikowski will present a lecture on how data transparency improves safety during new drug development at Chungbuk National University.
NATICK, MA – April 17, 2013 – Clinivation, Inc. announced today that clinivation Founder and CEO Joseph Kozikowski, M.D. will present a lecture at Chungbuk National University in Cheongju, Korea on data transparency and safety during the development of investigational new drugs.
As an authority on the development and commercialization of advanced medical technology, Dr. Kozikowski will share his perspectives in a lecture entitled, “Investigational New Drug Safety: U.S. FDA’s Evolution to Real-Time Transparency in Reporting.”
The lecture will address important recent developments and industry best practices, and will include the U.S. FDA’s current level of evidence approaches for causality determinations, operational definitions of “unexpected” in the context of adverse events or suspected adverse reactions, best practices in the filing of IND Safety Reports CIOMS Form 1for studies conducted outside of the United States, and implementation of the new U.S. FDA Final Rule for reporting of causally-linked events in the case of blinded studies.
The audience will include Korean and international faculty, students, industry executives, and government officials, and will be held on April 27, 2013 at The College of Pharmacy, Chungbuk National University, Cheongju, Korea. Further details are available in English and Korean printed and online announcements available through the Office of the Dean at The College of Pharmacy, Chungbuk National University.
Following the presentation, Dr. Kozikowski will be available for academic discussions and industry meetings to discuss the topics in greater depth. A reception will follow in Cheongju.
Quotes & Commentary:
“It is an honor and my pleasure to have been invited to lecture at CBNU, and I thank Dean Ki-Wan Oh and the faculty for their efforts in arranging this opportunity for international learning,” said clinivation Founder and CEO Joseph Kozikowski, M.D.
About Chungbuk National University:
Chungbuk National University (CBNU) is one of Korea’s leading educational and research institutions. A regional research center for Bio Health Industry Development, CBNU’s Biomedical Systems Development Center has been awarded funding by Korea’s Ministry of Health and Welfare.
The Health, Medicine, and Life Science Program was the first program to develop a systematic, interdisciplinary curriculum connecting and combining basic sciences and applied technologies.
As part of the Osong BioTechnopolis- Korea’s leading industry cluster for health, medicine, and life science related industries, research institutes, and government offices- CBNU will play a major role in Korea’s growing life sciences industry.