The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA's Clinical Investigator Training Course 2012 This course is designed for physicians, nurses, pharmacists and other health care professionals involved in clinical trials. Lectures presented by senior FDA experts as well as guest lecturers from industry and academia explore the scientific, regulatory and ethical aspects of clinical trials. They include discussion of non-clinical, early clinical, and phase 3 studies, issues in the design and analysis of trials, safety and ethical considerations and FDA's regulatory requirements related to the performance and evaluation of clinical studies. Registration link and course details: FDA's Clinical Investigator Training Course 2012 CME credits are available
Dates: November 13-15, 2012
Location: Holiday Inn, College Park, MD 20740
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM. Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
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