Eugenia Rom Mas Email & Phone Number

Madrid, Comunidad De Madrid, España

Esplugues Del Llobregat, Barcelona

- Management and design of clinical trials. Coordinating and following ethical, regulatory and contractual topics of the trials. Following the design and phases of all clinical trials.- Support in the selection of Clinical & Analytical CROs according to their qualifications, experience and areas of expertise for each clinical trial.- Evaluate the comparative dissolution profiles in order to potentially select the most successful candidates for the biobatches of the clinical trial. Biobatch selection report.- Feasibilities. Defining a first developing strategy. Understanding the science behind a product in order to define a first strategy. Identify any critical points for the development and propose ways to overcome them.- Preparation of Scientific Advice procedures and FDA Controlled Correspondence to establish drug development plans.- Clinical and scientific support to various departments of the company, especially with regard to Bioequivalence studies during the development.- Part of the innovation team. Innovation thinking and further implementation of any action derived until final target is accomplished. - Contribute to regulatory documents preparation, such as written expert reports, module 2 and 5 of the dossier and letters of deficiency.- Be updated of the clinical requirements (international legislation, guidelines and customer practices) and clinical procedures in all the company's export markets.- Administrative and Financial Management of the clinical trials.- Review and assess relevant clinical data, including review of applicable published literature.

Esplugues Del Llobregat, Barcelona

- Support in review and assessment of new research products.- Scientific and clinical support during new drugs development.- Support in management of clinical and analytical CROs.- Support in the management and monitoring of clinical trials, bioequivalence studies. Coordinating and following ethical, regulatory and contractual topics of the trials. Following the design and phases of all clinical trials.- Responsible/Support for the pharmacovigilance.- Liaising with regulatory authorities to ensure compliance with local, national and international regulations.- Contribute to regulatory documents preparation, such as written expert reports, modules 2 and 5 of the dossier and letters of deficiency.

Barcelona

Barcelona Y Alrededores, España

Master In Scientific Departments Of Pharmaceutical Industry, Industria Farmacéutica

Specialization: -Pharmacovigilance -Medical -Pharmacoeconomics -Regulatory

Bachelor'S Thesis, The Interaction Of Meloidogyne Graminicola And Pythium Arrhenomanes In Rice Roots.

Laboratory of Molecular Biotechnology of Ghent University, Epigenetics & Defence unit .

Bachelor Of Pharmacy (B.Pharm.), Pharmaceutical Enterprise

Exchange at Ghent University (Fall 2015) to do the Bachelor's Thesis. Five years long degree: 300 ECTS (credits).