Clinical & Translational Science Center
A Weill Cornell Medical College Multi-Institutional Consortium with:
Weill Cornell Graduate School of Medical Sciences / New York Presbyterian Hospital /
Cornell University, Ithaca / Cornell University Cooperative Extension, New York City /
Memorial Sloan-Kettering Cancer Center / Hospital for Special Surgery / Hunter
College of the City University of New York / Hunter School of Nursing / Hunter Center
for Translational and Basic Research (CTBR) / Animal Medical Center
1300 York Ave, Box 149, New York, NY 10065 • Tel: 646-962-8302 •
Fax: 646-962-0534 •
www.med.cornell.edu/ctsc
2016 CTSC Specialized Training Seminars
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April 18, 2016: Drug Development and FDA Regulations
This course provides an overview of the drug development process, including GLP, GCP, and GMP
processes. It is intended for early stage investigators from various disciplines with a need to develop and
understanding of the drug development process.
April 22, 2016: Medical Device GCP Overview
This course provides information across the full range of medical device clinical trial activities as an ideal
source of information for those new to clinical research and those requiring information specifically
relating to regulatory and practical aspects of medical device clinical research.
June 13, 2016: Preparing IND Submissions
This course teaches participants how to: find the required regulations and guidance documents for drug
and biologic submissions; use regulations and guidance documents to outline and construct a variety of
drug and biologic submissions; formulate a working knowledge of regulatory submissions, publishing,
and style guides; create checklists that encompass timelines and sections needed from contributors.
June 17, 2016: Investigator-Initiated Trials: Role and Responsibilities of the Investigator
This course provides an overview of: the applicable regulations for Investigator-Initiated Trials (IIT),
including the role and responsibilities of the individual investigator who acts as an investigator and a
sponsor in conducting the study; a review of the reporting requirements and essential documentation
required for these trials and the risks involved; helpful information on what sponsors look for in
industry-sponsored clinical trials.
Seminars will be led by industry experts with a wide variety of experience.
Registration must be returned via email to Sean Cruz at sec3001@med.cornell.edu