Ana Rivas Giner Email & Phone Number

Spain

Madrid, Comunidad De Madrid, España

Compliance y transparencia local para España y Portugal Regulatory affairs local contactLocal Quality responsible Phvig local contact España

Madrid Area, Spain

Started form a green field the operations in Spain of the pharma company.HA authorizations,pre-whole salers negotiation, registration, market access, organization . Pharmacovigilance, quality, med info expertise, foreign medication, imports, tenders.Local government of Madrid. Publicity. Client suport.Areas: Respiratory, oncology, allergy, pain managementIn one year launch of the company and sales.

Madrid Area, Spain

Started form a green field the operations in Spain of the pharma company.HA authorizations,pre whole sales negotiation, registration, market access, business plan, organization . Pharmacovigilance, quality, med info expertise.In one year launch of the company and sales.

Madrid Area, Spain

Regulatory director SpainDirect report to General manager & functional report to European Regulatory VP. Main activities: Responsible Pharmacist -Management of a team of 9 people for the retail, hospital, branded businesses ES representative and member of EU & International workshops and local deputy on the AESEG board. Organization and coordination of the Madrid group of AESEG for the allegations to the Law 29/2006 of medicinal products. pharmaceutical… Show more Regulatory director SpainDirect report to General manager & functional report to European Regulatory VP. Main activities: Responsible Pharmacist -Management of a team of 9 people for the retail, hospital, branded businesses ES representative and member of EU & International workshops and local deputy on the AESEG board. Organization and coordination of the Madrid group of AESEG for the allegations to the Law 29/2006 of medicinal products. pharmaceutical responsibility of drugs vis vis the health authorities. Activity of pharmaceutical affairs/medical information, business & industrial quality assurance for generic & brand products, pharmacovigilance for generic, branded products and for the innovative products (Copaxone, clinical trials). Goals:  Launch of 50 drugs/year in average (CPs, DCPS, MRPs, national files). inward licensing of 10 files in averagetransfer of 20 products in average. sourcing of 10 news active product ingredient in average. registration of 50 Marketing authorization in average (national or EU procedures). maintenance of 200 files (variations, renewals). filing for price and reimbursement for all productsPharmacovigilance “certification” (sales force of 50 reps). In one year from the establishment of the company launch of a portfolio of a generic company, and positioned between the leaders although arrived 9 years after the first generic companies where established in Spain. Show less

Madrid Area, Spain

Family owned pharma company, reporting to the general managerActivities: - SOP generation for GMP compliance-Coordination of the parts for manufacturing The MP Taukit-Regulatory filing in third countries (non European markets)Goals:-Design of the regulatory strategy of the Taukit file for Europe

Regulatory consultant Main activities: -Regulatory, clinical, Pharmacovigilance Goals:-Advice to pharmaceutical companies not established in Spain in regulatory aspects and acting in their representation -Advisor in Pharmacovigilance and clinical trials (submission to EC, protocol amendments, submission of final reports)-Advisor for medical devices companies to obtain CE mark in Spain

Madrid Area, Spain

Regulatory affairs technician Direct report to Regulatory DirectorActivities: -regulatory intelligence, regulatory technical workGoals: -Spanish responsible for the Core data sheet project. Elaboration from scratch of 5 SmPCs-Regulatory responsible for the maintenance of the CNS area-Five year renewals for all the products of the company

Licenciatura En Farmacia, Pharmacy

Master Bioetica

Activities and Societies: TFM defendida en Junio 2022 El papel de farmacéutico en la Ley de Eutanasia

Master Industria Farmaceutica

TFM defendido en Junio 1999 Registro de Medicamentos genéricos

Farmacia, Pharmacy

Postgraduate Degree, Educación Clasica Y Humanidades