Adair TurnerPrinciple, Consultant, Director RegOps, PharmaLex |
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Parul PatelSenior Product Consultant, LORENZ Life Sciences Group |
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Karl-Heinz LoebelDirector, Principal Consultant RegOps Industry/Agency Liaisons, PharmaLex |
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Akira YamaguchiCTO, LORENZ Life Sciences Group |
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Melissa RappManager, RegOps, PharmaLex |
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Jan WermuschProduct Manager, LORENZ Life Sciences Group |
Beginning later this year FDA will reject regulatory submissions that include study data that does not conform to the required standards specified in the FDA Data Standards Catalog.