CDER Small Business Assistance Industry Workshop: Clinical Trials and Electronic Submissions
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) is announcing an industry workshop entitled ‘‘CDER Small Business Assistance – Clinical Trials and Electronic Submissions.” This two day event will be held in two California locations consecutively. The first workshop will be held in Los Angeles, CA, on September 26-27, 2011, followed by a second in San Francisco, CA, on September 28-29, 2011.
Location(s) - (REGISTER THROUGH THESE LINKS)
These meetings will not be taped or webcast.
There is no fee to register for this meeting. Participants will receive confirmation of registration via e-mail.
As there are limited seats available, please notify us of cancellations one week in advance of the meeting.
If you require special accommodations due to a disability, please contact CAPT Brenda Stodart at 301-796-3400, at CDERSmallBusiness@fda.hhs.gov at least 7 days in advance of the meeting.
The purpose of this workshop is to educate the small pharmaceutical industry on FDA regulations and requirements as they pertain to different stages of the drug development process. CDER hopes to expand our outreach and encourage maximum attendance by offering the workshop in two separate locations.
Topics to be presented 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
- eCTD (electronic Common Technical Document)
- ESG ( Electronic Submissions Gateway)
- eDRLS ( electronic Drug Registration and Listing)
CAPT Brenda Stodart