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 and key aspects related to rare disease drug development and clinical trials.
The meeting will be held on October 8, 2010, beginning at 9:15 a.m., at the following location:
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 available through NLC and nearby hotels. *
Metro Rail Directions
Travelers from Reagan National Airport have the option of using the DC area’s Metro Rail System (see the Metro System Map). Please refer to the Washington Metropolitan Area Transit Authority's website for public transportation information: www.wmata.com
The closest Metro Rail station is Silver Spring (http://www.wmata.com/metrorail/Stations/station.cfm?station=31) which is on the Red Line. Metro station is approximately 8 miles from White Oak Campus. From National Airport, riders may take the Blue Line to the Red Line (transfer at Metro Center) or the Yellow Line to the Red Line (transfer at Gallery Place). From the Silver Spring Station, take taxi to the building or see information below for “Ride-On Bus” (operated by Montgomery County).
Ride-On bus route 22 operates between the Silver Spring Metro Station and White Oak Campus: http://www.montgomerycountymd.gov/tsvtmpl.asp?url=/content/dot/transit/routesandschedules/allroutes/route022.asp
Hilton Washington DC/ Silver Spring
8727 Colesville Road
Silver Spring , MD 20910
Silver Spring Courtyard North (Marriott)
12521 Prosperity Drive
Silver Spring , MD 20904
Silver Spring Residence Inn (Marriott)
12000 Plum Orchard Drive
Silver Spring , MD 20904
There is no registration fee.
REGISTRATION IS NOW CLOSED DUE TO OVERWHELMING RESPONSE.
Space is limited to 150 participants. We appreciate advance notice of cancellations or replacements. Participants will receive confirmation of registration.
* Fees for accomodations are not included as part of the registration.
If you require special accommodations due to a disability, please contact CDR Brenda Stodart at 301-796-3400, at CDERSmallBusiness@fda.hhs.gov at least 7 days in advance of the meeting.
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.
- 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
- "DSI and Bioresearch Monitoring (BIMO)" - Susan Thompson, MD, Medical Officer, Division of Scientific Investigations
- "Rare Diseases Clinical Development at CDER" - Anne Pariser, MD, Rare Diseases Program, Office of New Drugs
- "A Primer for Understanding the Drug Development Process" - Robbin Nighswander, RPh, MS, Chief, Project Management Staff, Division of Neurology Products
- "Meetings with FDA" - Hyun Son, PharmD, Safety Regulatory Project Manager, Division of Special Pathogen and Transplant Products
Handouts will not be printed and available at the conference. Presentations will be added to the website and announced to participants as they become available for printing.
For further information about this meeting, contact:
CDR Brenda Stodart