• Advise on the need, design, interpretation, and regulatory relevance of clinical pharmacology studies, including formulation, food effect, drug interaction, QT/QTc, organ impairment, and special population assessments where applicable. • Support preparation for and participation in interactions with BfArM, EMA, FDA, and other relevant authorities, including development of clear scientific arguments and response strategies. • Experience with DMPK, ADME, PK/PD, PopPK, PBPK, exposure–response, dose selection, drug interaction strategy, formulation-related clinical pharmacology, safety considerations, and special population assessments. • Experience preparing for and participating in interactions with regulatory authorities such as BfArM, EMA, FDA, or comparable agencies.
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