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

2. 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)

3. 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

4. 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

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