Drug Seminar
Dear Colleague:
The Food and Drug
Administration and the Central Atlantic States Association of Food
and Drug Officials (CASA) are jointly sponsoring a one-day seminar
on May 16, 2005 for the pharmaceutical industry. The program will
provide information about Pharmaceutical GMPs for the 21st Century,
importation and exportation of active pharmaceutical ingredients and
finished drug products, FDA’s efforts to curb counterfeit drugs, and
an overview of current inspectional activities and initiatives.
In September 2004, FDA
issued its final report on Pharmaceutical GMPs for the 21st
Century. This initiative
encompassed a complete
assessment of FDA’s existing GMP programs
and advocates risk management
practices and science-based policies.
Seminars
such as this one provide FDA with a forum for industry outreach and
the regulated industry with the opportunity to speak directly with
agency officials about these program changes.
The seminar will
be held at the state-of-the-art Conference Center Niagara Falls,
Niagara Falls, NY; lodgings are available at the Holiday Inn Select
which is located across the plaza from the Conference Center. To
ensure availability of rooms, you must call the hotel directly at
716-285-3361 and state that you are with the CASA/FDA Drug Seminar
no later than May 2, 2005.
The training
cadre for this seminar includes FDA officials from the Center for
Drug Evaluation and Research, Rockville, MD, as well as the
Philadelphia District office. We believe you will find the program
to be valuable to your company and its employees. Because the space
at this seminar is limited, please reserve your place early. A
registration form, seminar agenda, and additional conference details
are enclosed with this letter.
We look forward
to seeing you at the seminar.
Susan M.
Setterberg
Regional Food and Drug Director
Central Region
FDA Field Drug Committee Advisor
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