Este taller es gratis para aquellos que puedan asistir al area de Washington, DC/ Silver Spring, MD en octubre 8 ***************************** CDER's Small Business Assistance Educational Forum: The Investigational New Drug (IND) Process; Public Workshop October 8, 2010 The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug (IND) Process. The meeting will be held on October 8, 2010, beginning at 9:15 a.m., at the following location: National Labor College (NLC) George Meany Campus 10,000 New Hampshire Ave., Silver Spring, Maryland 20903 (301) 431-6400 Free parking is provided. Free wireless access on campus. Lunch will not be provided but there is a cafeteria on premises and several fast food options within walking distance. Sleeping accommodations are provided by NLC and nearby hotels. The meeting will not be videotaped or webcast. RegistrationThere is no registration fee. Space is limited to 150 participants. We appreciate advance notice of cancellations or replacements. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the public meeting will be provided on a space-available basis beginning at 8:45am. Online registration is available. Registration will close on Thursday, September 30, 2010. Online Registration If you need special accommodations due to a disability, please contact Brenda Stodart at 301-796-3400, at CDERSmallBusiness@fda.hhs.gov at least 7 days in advance of the meeting. Meeting Agenda (PDF - 42KB)The Investigational New Drug (IND) application process is a crucial step in the drug development and approval process. The objective of this workshop is to clarify and explore fundamental aspects of the IND. Highlights include: Drug Development timeline Phases of an IND Types of Meetings with FDA Clinical Development of rare diseases Examples of recent rare disease programs Rare disease help and information at FDA Goals of Inspections: Clinical Investigator Program Selecting Clinical Investigators for Audit FDA Expectations of Clinical Investigators Inspectional Procedures/DSI Actions Presentation slides We will not be providing handouts at the workshop this year. Presentations will be added as they become available prior to the workshop. Contact UsFor further information about this meeting, contact: Brenda Stodart 301-796-3400 e-mail: CDERSmallBusiness@fda.hhs.gov