
Medical Management for Health Care Industries
France

Medical Management for Health Care Industries
France
Medical Project Leadership for Health Care Industries
experience in :
Clinical Medicine
Drug Development
Project Management
Orphan Drugs
Interactions with Stakeholders
Medical Communication
Medical Information
Clinical Medicine; DIU CESAM (medical statistics); DIU FIEC (clinical trials); Healthcare Management; Medical Devices;
Animal Experiments
(Privately Held; Pharmaceuticals industry)
May 2009 — November 2009 (7 months)
- management of the follow-up process for an orphan designation with EMEA and FDA
- management of a scientific advice request from AFSSAPS, EMEA
- elaboration of the orphan drug development project
(Government Agency; Government Administration industry)
October 2008 — March 2009 (6 months)
- created and managed a database of stakeholders, participated in management of interactions with key interested parties (including patients and consumers organizations, healthcare professionals organisations, learned societies etc)
- managed external queries from patients and healthcare professionals
- participated in meetings of several Scientific Committees and Working Parties, including the Committee of Human Medicinal Products (CHMP), but also PDCO, COMP, CAT, CVMP, HMPC, as well as Working Parties (Efficacy, Safety, Pharmacovigilance etc)
- acquired an extensive knowledge of the European pharmaceutical legislation, Community procedures, rules and mechanisms of EMEA’s internal functioning
(Privately Held; Pharmaceuticals industry)
March 2007 — October 2008 (1 year 8 months)
- General management, multi-disciplinary project management
- Public relations with Stakeholders (including patients’ associations, healthcare professionals, academia, university hospitals, research organisms, bioclusters, associations etc),
- Representation of the company in all events with key Stakeholders (congresses, boards, public events)
- Communication management
- Management of an orphan medicinal product designation request from EMEA (medical writing of the application, managing application process with EMEA COMP, results - orphan designation No EU/3/08/531 successfully obtained), composition of the dossier for orphan designation for FDA
- Day-to-day management of the team, commercial negotiations
(Hospital & Health Care industry)
May 2006 — April 2007 (1 year )
- medical information provision to general public and healthcare professionals (mainly to physicians, including hospital emergency services, pharmacists and occupational and public health specialists) about intoxication by natural toxins, drugs, chemical products, cosmetics etc
- medical information provision about drug adverse effects
- reception and initial treatment of ICSR (mainly from general public), liaising pharmacovigilance team, management of safety alerts for drugs and food
- work with toxicology and adverse effects database (input, output, statistics), bibliographic research
(Hospital & Health Care industry)
September 2001 — November 2005 (4 years 3 months)
- participation in clinical medical, surgical and outpatient activity
- organisation of clinical staff meetings, grand rounds
- scientific writing activity (research papers, books chapters)
- training and courses for medical students
- organisation of and participation in scientific events, workshops and congresses in collaboration with stakeholders
- management of information & communication projects via internet and multimedia supports
Master in Healthcare Company Management , Healthcare Management , 2006 — 2007
curriculum : strategy, finance, marketing, human resources in healthcare Industry, economic diagnostics & expectations, negotiation, commercial management, market & panel studies, project management, international healthcare systems, international regulatory issues, quality management, audit, international distribution and logistics of healthcare products, innovation in healthcare industry, business development and corporate strategy, intellectual property, biotechnology management
Graduation thesis: "Rare Diseases and Orphan Drugs: uncovered need, incentive measures and strategy of development for biotechnology start-up"
University Diploma , Medical Devices and Biologicals , 2006 — 2007
curriculum:
- Regulation and norms for Medical Devices and Biologicals
- Certification procedures, CE marking, preclinical and clinical evaluation
- Clinical trials of medical devices, evaluation and quality management, vigilance and risk management
- Assessment of risk/benefit ratio, reimbursement issues
Postgraduate training , Postgraduate medical training in Public Health , 2006 — 2007
Medical Toxicology
Pharmacovigilance
Practical Training: Center of Toxicology and Pharmacovigilance of Marseille
Thesis:
"Rares Diseases and Orphan Drugs: uncovered need, incentive measures and strategy of development for biotechnology start-up"
DIU FIEC (University Diploma) , Training of Investigator in Clinical Trials , 2005 — 2006
Curriculum:
- methodology, regulation and ethics of clinical trials
- post-authorisation follow-up, pharmacovigilance
- application in different areas of clinical pharmacology
internship : University Centre of Clinical Pharmacology and Therapeutic Evaluation, Marseille
- participation in realisation of clinical trials of phases 1-3
- participation in a phase 1 clinical trial as a healthy volunteer
DIU CESAM (University Diploma) , Statistics applied to clinical trials , 2005 — 2006
Modules METHO, SPEC & STARC
curriculum:
- drug development: from pre-clinical trials to phase 4
- medical statistics
- methodological principals of comparative clinical trials
- measurements, quality of life, study protocol
- pharmacovigilance
- Good Clinical Practice
- analysis of a clinical trial, biases, meta-analysis
- marketing authorisation dossier in France and European Union
University Diploma on Animal Experiments , Animal Experiments , 2005 — 2006
Diploma giving right to perform experiments on animals in France (special ministerial authorisation)
curriculum:
Good Laboratory Practice in animal experiments:
- Anatomy, physiology and pathology of laboratory animals
- Animal model, use of animals in pharmacological and toxicological studies, anesthesia,
- Ethical issues, optimisation of animal numbers, alternative methods
University Diploma , Multimedia and Pedagogy in Healthcare , 2004 — 2005
curriculum:
- multimedia and medical pedagogy, information management
- evaluation tools and methods
- distant communication and learning tools and platforms, Rich media
- methodology and structurisation of training
- legal issues and copyright law
graduation work:
- creation of web-site http://www.orl-marseille.com (actually more than 100.000 visitors/year), leading information source in pediatric otolaryngology in french language in the world
Postgraduate training , Postgraduate medical training in Otolaryngology and Head & Neck Surgery , 2001 — 2005
Medical Resident programme in Otolaryngology, Head and Neck Surgery, Paediatric Otolaryngology, Audiology and Phoniatrics
M.D. , human medicine , 1994 — 2000
graduated with honors
Healthcare Industry, Medical Information, Pharmaceutical Industry, Medical Devices, Biotechnology, Orphan Drugs, Clinical Research