UNIVERSITY OF WISCONSIN - MADISON
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Successful leadership of NCE/NBE, drug-device combinations and other line extension development teams requires more than simply generating technical information for inclusion in regulatory filings. Training for the management of CMC projects can be key for leaders who wish to move successful projects forward. The course will cover effective leadership skills and essentials, team dynamics, meeting mechanics, and decision making styles and mechanisms – all in the context of CMC development.
Designed specifically for development programs and associated regulatory filings for oral and parenteral dosage forms and drug-device combination products, this course will cover key technical activities carried out in drug substance, drug product, and analytical method development leading to the initial IND and subsequently to an NDA/CTD.
In addition, the course covers project planning for regulatory filings, including timing of events and interdependencies of the tasks required to advance a candidate to Phase 1 and beyond. Filing documents are examined, section by section, including content descriptions and the typical level of detail consistent with FDA guidance documents. Other activities covered include the preparation, testing, packaging and labeling of clinical trial supplies and the associated elements of quality assurance and regulatory compliance.
This program has been developed and will be presented in cooperation with the Zeeh Pharmaceutical Experiment Station in the School of Pharmacy at the University of Wisconsin-Madison.
Please contact the program coordinator for more information.
Eric Buxton, PhD
Division of Pharmacy Professional Development 777 Highland Avenue Madison, WI 53705 (608) 262-2431 FAX (608) 265-2259 firstname.lastname@example.org