CDER Small Business Assistance: Clinical Trials Forum, April 21, 2011
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) Small Business Assistance Program, is announcing a public forum on Clinical Trials.
The meeting will be held on April 21, 2011 from 9:00 a.m. to 4:45 p.m.
Registration starts at 8:30 a.m.
FDA White Oak Campus
Building 31, Room 1503 - Great Room
10903 New Hampshire Avenue
Silver Spring, MD 20993
Telephone: 301-796-2336 or 301-796-3400
The meeting will not be taped or webcast.
Free parking is provided. Free wireless access on campus. Lunch will not be provided but there will be a food kiosk on premises.
Public Meeting Attendee Information
Registration is closed.
If you require special accommodations due to a disability, please contact CAPT Brenda Stodart at 301-796-3400, or CDERSmallBusiness@fda.hhs.gov at least 7 days in advance of the meeting.
The Clinical Trials forum will provide small businesses with an opportunity to learn about various aspects of clinical trial design, both strategic and technical, from FDA experts in the field. The topics to be discussed include:
- Clinical trial design - the phased approach and the staged approach
- FDA's Bioresearch Monitoring (BIMO) Inspection Program
- Challenges to conducting clinical research in the 21st century
- Practical concerns of electronic source documentation
- Different types of pharmacokinetic studies conducted during drug development
- Importance of bioequivalence studies
- Strategic Quality for Clinical Trials
- FDA inspection process
- "Clinical Trial Design" - Sue-Jane Wang Ph.D, Office of Biostatistics, Office of Translational Science, CDER (PDF - 541KB)
- "The Genesis of the Human Subjects Protections Regulations and Biomedical Research in the 21st Century " - Janet Donnelly, RAC, CIP, Human Subjects Protections Team, Office of Compliance, Division of Scientific Investigations, CDER (PDF - 228KB)
- "Electronic Source Documentation in Clinical Investigations" - Sean Kassim, Ph.D, Informatics and Infrastructure Team, Division of Scientific Investigations, Office of Compliance, CDER (PDF - 399KB)
- "Pharmacokinetics in Clinical Trials" - Charles (Chuck) Bonapace, Pharm.D, GLP and Bioequivalence Investigations Branch, Division of Scientific Investigations, Office of Compliance, CDER (PDF - 560KB)
- "Strategic Quality for Clinical Trials, from Design through Reporting" - Winifred (Ann) Meeker O’Connell, MS, Policy Advisor, Division of Scientific Investigations, Office of Compliance, CDER (PDF - 551KB)
- "Preparing for an Inspection" - Winifred (Ann) Meeker O’Connell, MS, Policy Advisor,Division of Scientific Investigations, Office of Compliance, CDER (PDF - 410KB)
Handouts will not be printed and available at the conference. Presentations will be added to the CDER Small Business website Workshops and Webinars and announced to participants as they become available for printing.
For further information about this meeting, contact CAPT Brenda Stodart, phone: 301-796-3400, or by e-mail: CDERSmallBusiness@fda.hhs.gov