Elena M.

Background

About Elena M.

Broad and long experience in Pharma industry (>28 years), focused on cornerstones of the Medical area (Clinical Research, Medical Affairs and Pharmacovigilance). Also experience in Regulatory Agency (6 years)-Experience in Clinical Research: 26 years.*Design, implementation, conduct, oversight, coordination and accountability of clinical trials and development programmes (phases I to IV), non interventional studies (quality of life, pharmacoeconomics, therapy compliance, epidemiology,…) and compassionate use programs in different therapy areas/diseases *Accountable for Standard Operating Practices, Training, Risk Management, Quality control, Audits and Outsourcing Management -Experience in Medical Affairs: 17 years.*Launches of new products and new indications *Annual strategic plans of the products *Support activities for marketed products and products in development (advisory boards, congresses, presentations, publications, medical education, promotional materials and activities, training, …)*Medical Governance/Risk Management -Experience in Therapy Areas:*Respiratory: 13 years. Products for asthma, COPD, rhinitis. Adults and pediatrics.*Cardiovascular: 5 years. Products for arterial hypertension, pulmonary hypertension *Infectious Diseases: 5 years. Products for HIV, bacterial infections, flu, antrax *Immuno-Inflammation: 5 years. Products for rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, giant cells arteritis *Dermatology: 3 years. Products for acne, atopic dermatitis, bacterial infections *Anesthesiology: 2 years *Critical Care: 2 years *Metabolism: 2 years. Diabetes. Dyslipemias *Thrombosis: 2 years *Gastro: 2 years -Experience in Regulatory Agency: 6 years. Clinical assessment of new medicines (both european and national applications). Scientific Advice. Therapeutic Positioning Reports ("IPT"). EMA expert -Experience in Pharmacovigilance: 4 years-Experience in people/team management: 26 years with direct reports.