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CDER Forum for International Drug Regulatory Authorities, June 17-21, 2013
U.S. FDA’s Center for Drug Evaluation and Research (CDER) will be presenting an updated CDER Forum for International Drug Regulatory Authorities (CDER Forum) on June 17-21, 2013 and not in April as in the past. The change in date reflects the need for our international colleagues to process their travel paperwork well in advance of the meeting.
The 16th CDER Forum will discuss the identification, evaluation, and monitoring of adverse events in three key areas of the drug life cycle: during clinical trials, FDA application review, and postmarket monitoring and analysis. More details will be provided a recently approved drug product in future announcements. This revamped CDER Forum will also provide opportunities to learn from one another and promote discussion of common areas of concern.
The CDER Forum will be held in College Park, Maryland. There is no registration fee for the program, however all attendees are responsible for their own travel and hotel expenses.
Please direct any questions to the CDER Forum mailbox: CDERForum@fda.hhs.gov.
Please include the following information about the proposed attendee:
- Country and Drug Regulatory Authority
- Topic/Area of Interest
Holiday Inn Hotel - College Park, Maryland
10000 Baltimore Avenue
College Park, MD 20740
Hotel Registration Information:
June 16 – 22, 2013
$129.00 single, $142.00 double, $155.00 triple (per night)
Plus 11% applicable taxes
Rate includes breakfast each morning in the hotel restaurant
Please email the hotel directly with your reservation request (firstname.lastname@example.org) or call Asha on her direct line: 240-542-1226. Include name, arrival and departure dates, and email address where confirmations can be sent. If double occupancy is requested, the hotel will need both names. Also, the hotel will need a credit card to guarantee your reservations.
For further information about the CDER Forum, contact:
Justina A. Molzon, MS Pharm, JD
Associate Director for International Programs
Center for Drug Evaluation and Research
United States Food and Drug Administration
U.S. Department of Health and Human Services