PROGRAM
Basics of Drug
Development, Production
and Regulatory Affairs
(Module 1)
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Mentor:
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Prof. Dr.
M. Schubert-Zsilavecz,
Prof. Dr. T. Dingermann
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Location:
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Johann
Wolfgang Goethe-Universität
Frankfurt am Main, Campus
Riedberg, Seminarraum N100,
015
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Date:
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Wednesday,
March 1st, 2006
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9:00-9:30
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Welcome
(Prof. Dr. R. Steinberg
(Präsident der JWG-Universität),
Prof. Dr. M. Schubert-Zsilavecz,
Prof. Dr. T. Dingermann)
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9:30-10:30
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Drug Regulatory
Affairs I (Prof. Dr. H.
Schweim, Präsident
Bundesinstitut für
Arzneimittel und Medizinprodukte
(BfArM) a. D., heute Lehrstuhl „Drug
Regulatory Affairs“ Uni
Bonn)
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10:30-10:45
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Discussion
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10:45-11:45
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Drug Regulatory
Affairs II (Prof. Dr. H.
Schweim)
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11:45-12:00
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Discussion
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12:00-13:00
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Lunch
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13:00-15:00
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Fundamentals
of Clinical Trials (Dr.
A. Franken, Bundesverband
der Arzneimittel-Hersteller
e. V. Bonn)
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15:00-15:30
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Coffee
Break
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15:30-17:30
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Challenges
in the drug development
of monoclonal antibodies
for human use (Dr. H.-C.
Mahler, Hofmann-La Roche,
Pharmaceutical and Analytical
R&D, Head of Formulation
Development Biologicals)
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17:30-18:00
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Round-table
discussion (Prof. Dr. M.
Schubert-Zsilavecz, Prof.
Dr. T. Dingermann)
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