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consultante quality & affaires pharmaceutiques médicaments, dispositifs médicaux
Catégorie :

Consulting

Date de dernière mise à jour :

27 avril 2017

Lieu :

côte d'azur

CV :

Work

IPC - Since 2003 > International Pharmaceutical Consultancy – Neuilly (92)
Head of Quality & Pharmaceutical Affairs
Quality Assurance: quality intern & extern audits, quality system & SOP redaction, quality risks, validations, CTD M3 and MD design dossiers [drugs, medial devices]
Regulatory Affairs France/ Europe: MA files, CMC, pricing files, CE and LPP marking files, Cosmetic products files, DM CE marking files, nutrition products files, Formations
Clinical Research: Lead of projetcs, Redaction of protocols/CRF/study documents, Regulatory submissions, Management of studies, Monitoring according BPC/ICH of phases I /II /III, IV clinical trials; Clinical reports

DIADEMIS – Since 2015 > DIADEMIS – Brunoy (91)
President
Heathcare Training and Consulting for pharmaceutical products, nutraceuticals, cosmetics and medical devices, International Auditing

LEEM - 2003 > Les Entreprises du Médicament, Leem – Paris (75)
Regulatory Affairs France/ Europe : Working groups « ERA » and « FRA », « Environment/Pharmaceutical firms 2003 » study, « Revision of the Pharmaceutical Legislation », and « Essentially similar products » study, follow up of MA, National, MR and centralised procedures, answer to the firms questions, meetings with the AFSSAPS, regulation follow-up

GSK 2002 > GlaxoSmithKline – Marly-Le-Roi (78)
Clinical Research Coach CNS, gastroenterology, urology Department:
International multicentric clinical research projects (trial management, writing of protocol, summary, informed consent, financing follow up, feasibility, submission to Regulatory Authorities, monitoring : initiation site visit, verification of trial data and conduct in compliance with GCP, SOPs, BPC, ethical laws and applicable regulations, verification of investigational products, management of AEs and SAEs and withdrawals, CRO and sites audits, queries follow up, submission of written report of site visit, final visit

IBM 1995 > IBM – La Défense (92)
Responsible for internal financial relations, financial and human resources departments:
Implementation of personal and quality objectives

University 1995 > University, primary school – Paris (75)
Tutoring (biology & mathematics) at home


Educaton
2016
Certification ISO 9001:2015, Fréa – Paris

2013-2015
Post graduate degree in Toxicology, in progress (University of Pharmacy - Paris V)

2009-2010
Post graduate degree in Quality audits management & conducting (BPx, ISO), obtained with high distinction (University of Pharmacy - Paris V) Major of promotion

2002 - 2003
Post graduate degree in R&D and Regulatory Affairs, obtained with high
distinction (European and French Regulatory Affairs, Health law and economy
University of Pharmacy - Paris V, Lille II, ESSEC) Major of promotion

2001 - 2002
Biological and pharmaceutical studies: Post graduate degree in R & D - Neurobiology
and Neuropsychology, obtained with distinction (RD development of psychotropic
products, psychopharmacology , clinical research, regulations)
University of Sciences - Paris VII


1997-2001
Master’s degree of Biochemistry – University of Sciences Pierre et Marie Curie PVI


Languages
English: fluent
German: intermediate
Arabic: debutante
Portugues: debutante

Computer Skills

Standard software, Mathematical, Pharmaceutical software



Interests

Complementary Education: classical and western riding, classical guitar, analysis and composition studies, choir / BAFA: cultural activities license / first aid

Leisures: riding, horse ethology, artistic dressage, skiing, walk and hike, bike, reading, music, President of AMAP du Val d’Yerres (Association for the promotion of organic argriculture)

Travels: Africa (Guinea, Marocco, Canary Islands, Tunisia, Algeria), Europe (UK, Germany, Italy, Spain, Portugal, Belgium, Bulgaria, Yugoslavia, Switzerland, Greece, Austria, Czech Republic, etc.), USA, India

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