Situation of current Medical Approval System

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Presentation transcript:

Situation of current Medical Approval System Raul Lafuente Medical Manager OPSA November 2006

Current Areas of OPSA Action Clinical Research Clinical Trials Regulatory Affairs Maintenance of product licences Health Outcomes Price and Reimbursement Pharmacovigilance Adverse reactions reports Medical Information Marketting Materials External queries Sales Force Training Medical Affairs Medical support to marketing (promotion, training, KOL management)

Adacolumn Responsible Person Development Area R. Lafuente J. Aregall Clinical Trials X Regulatory Affairs Health Outcomes Price and Reimbursement Pharmacovigilance Medical Information Queries from external customers Medical Affairs

Tolvaptan & Tetomilast Responsible Person Development Area R. Lafuente J. Aregall Clinical Development x - Regulatory Affairs X Health Outcomes Price and Reimbursement Pharmacovigilance Medical Information Queries from external customers Medical Affairs

Abilify No current responsabilities for OPSA medical team All medical department issues transfered to BMS