María Servera Email & Phone Number

Regulatory AffairsCLINICAL TRIALS EXPERIENCE:Review of accuracy and feasibility of draft documents for all kinds of CTIS submissions , in order to ensure totally accurate submissions. Procurement of local RA documents required for the abovementioned submissions. Development, quality review and publication of the essential/required documents for all kinds of submissions to the RA and EC, based on regulatory requirements in national submissions.Support and building of solid knowledge of Clinical Trials operations (phase 1, 2, 3 and post-marketing) in cooperation with other local teams and also global teams. Provision of expertise for pre-submission activities to stakeholders: creation of Country Outreach documents, translations, coordination and planification of different steps for submission, etc.Management and coordination of “queries” resolution.Management of the information of studies/tests updated in REEC.Management of application for import/export samples to the MoH. MAINTAIN OF PRODUCTS LIFECYCLE:Management of all submission types for products according to procedures: CP, MRP and NP.Support to teams for cross-functional projects related to development of medicines, external and internal requirements, based on continuous improvement of regulatory processes.Provision of regulatory logistic to the commercial product/medical teams with the aim to promote and develop products and to implement special projects.

Professor of mathematics, statistics and chemical analysis as part of the degree of Pharmacy and Biology

Uib

Predoctoral researcher in national and international projectsPreparation of seminars, workshops, meetings and projects. Design of protocols and standard operating procedures. Data and bibliography management, statistical analysis and processing results, use of bioinformatics tools.Biochemistry/molecular biology and genetic technics.Professor of subject “Research study”.Research in Nutrigenomics.

Management, systems, accounting, orders and warehouse. Active dispensing, electronic prescription, analysis of blood parameters.Development and control of Magistral Preparations and PDS (Personalized Dosing System).

Palma, Islas Baleares, España

Scientific medical and pharmaceutical advise to pharmacist. Medical information functions: Drug and regulation consulting, drug interactions, foreign drugs, toxicology, nutrition, magistral formulation, dermo pharmacy, medical devices and others. Provide REEC information regarding current Clinical Trials.Publications, magazines and communications of the College Official of Pharmaceutics, teacher of training activities and courses.Management of the College of Pharmacists library. Pricing Magistral Preparation.

Marseille-En-Beauvaisis, Hauts-De-France, Francia

Pharmacy HospitalCollaboration in hospital laboratory, preparation of medications and Magsitral Formulas for hospital use.Collaboration with all of the hospital departments.

Course Fundamentals Of Clinical Trials, Clinical Trials

Activities and Societies: Postgraduate Course “Fundamentals of Clinical Trials”

Doctor Cum Laude, Biología Fundamental Y Ciencias De La Salud/ Bioquímica

International Master Of Nutrition And Dietetics

Stage Graduate Pharmacy, Farmacia Clínica, Hospitalaria Y De Atención Primaria, Intercambio Universitario

Pharmacy Degree