41 rue de Villiers
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Veille réglementaire – KNOWLEDGE. ACCELERATED.
PharmaLex a.r.c. vous propose un service de veille réglementaire organisée au niveau européen et français et portant sur l’ensemble des produits de santé : médicaments, dispositifs médicaux, cosmétiques, nutrition et biocides.
Notre plateforme KNOWLEDGE. ACCELERATED. offre à nos clients :
- Des newsletters 2 fois par semaine avec une analyse d’impact de chaque actualité.
- Une base de données, leur permettant de retrouver tous les articles publiés.
- Un espace client pour personnaliser leur abonnement.
N’hésitez pas à contacter nos équipes pour toute autre demande de veille réglementaire personnalisée.
Organisme de formation depuis 1982, a.r.c. Pharma a à partir de 2016 mis en place une gamme étendue de stages interentreprises construits autour de son cœur de métier. Aujourd’hui dénommée PharmaLex a.r.c. Formations nous poursuivons l’objectif d’accompagner l’ensemble des acteurs des industries de santé dans l’appropriation ou le perfectionnement des connaissances ou dans le développement de nouvelles approches sur ses aspects techniques, réglementaires, méthodologiques ou organisationnels.
Key members of our team
Blandine Bourrinet is dedicated to pharmaceutical Responsibility and area of ‘exploitant’ in France; she also gives advices on anti-gift law, transparency and certification of sales representative network. She is responsible for internal/external audits and she is the Head of the French training department (Regulatory & PV)
She is a pharmacist who joined us in 2015, after 15 years in pharmaceutical companies and 7 years in a training organization.
Mathilde Gaultier-Renouf has over 10 years of experience in drug safety in 2 international pharmaceutical industries (MSD Animal Health and Servier). She has a deep understanding of ICSRs processing, drug safety reports writing, interaction with CAs, involvement in CAs inspections, medical and drug safety training and signal detection.
Mélanie Alhusban has over 10 years of experience in pharmaceutical industry. In charge of the CMC and RegOPS (publishing, submission, …) units, she has joined us in October 2017. She has participated, amongst other activities, in managing regulatory projects, has prepared and contributed to write and review regulatory documents but also to expand the existing portfolio.
Christelle holds a PhD in Pharmacology and brings 20 years of experience in the early development of different types of products (small molecules, biologics, ATMP) in musculoskeletal diseases (osteoarthritis, rheumatoid arthritis), inflammation and aging. She began her career at University of Montreal and pursued in Europe with consulting for biotechs, pharma companies and food industries.
Céline Hocquet-Merlin has over 17 years of experience from process development, to CMC, RA or quality. During the past 8 years among us she gained strong experience in consulting activities, expertise in quality guidelines, variations regulations, pharmaceutical dossiers writing, due-diligence for all pharmaceutical forms, technical and GMP-linked questions (CMC compliance).
Dr Patrick Larcier has over 30 years of experience in understanding non-clinical, clinical and regulatory development. He is experienced in co-developing products in both EU/US regions, conducting Early Access and Compassionate Use Programs, setting and monitoring pre- and post- market vigilance activities
His main focuses: innovative medicines in oncology, auto-immune disorders, and orphan indications.
Audrey Finesso provides Drug development (included early stage) and RA strategy for SME, biotech and pharmaceutical companies for EU/US. She has experience with Scientific Advices meetings with European Agencies (EMA, ANSM, BfArM), orphan drug designation in Europe and Type B & C meetings with the FDA
Also, she has a strong experience in diseases with unmet medical needs/innovative products.
Véronique Mougeot, throughout her 27 years within Pharmalex, gathered experience in consulting in RA, medical writings of all types such as clinical/nonclinical expertise, clinical variations, open access dossiers, etc. During her career she gained experience in areas such as writing protocols, preparation of MA to regulatory agencies, PK and statistical analysis.
41 rue de Villiers, 92200 Neuilly-sur-Seine