Catherine Chaudron Email and Phone Number
Do you need support from Design control to post-market follow-up?Calicéos accompanies you all along the life of your products or of your companyThe objective of Calicéos is to provide expertise, leadership and support, at national and international levels, in all matters related to companies’ compliance and the development of their devices (class I to III MD, combined MD) from design to post-marketing follow-up: :• Product Development (development strategy, support to design verification and validation activities (in accordance with applicable standards and regulations (e.g ISO 13485, 21CFR820)),• Regulatory Affairs (regulatory strategy for development, worldwide registration and life-cycle management, technical documentation)• Quality (diagnostic and strategy for compliance to applicable regulations, standards, quality program (ISO13485, MDR 2017 :745, MDSAP...), audit)• Medical Affairs (strategy and positioning of product, scientific support to marketing and Health Professional KOL network, medical affairs studies)• Market follow up (activities related to PMS / PMCF, support to vigilance process)Calicéos was born from the association of two experts in the medical devices field, the two founders having more than 50 years of experience in the medical device industry. They have held senior/executive international positions in Regulatory / Clinical Affairs and Quality, in Research and Development and Medical Affairs.Calicéos’ assets are:• Versatility of skills demonstrated in various fields of medicine (ophthalmology, rheumatology, aesthetic dermatology, dentistry, gynecology, urology) through the development and commercial success of medical devices, whatever the class.• An effective synergy due to a fruitful collaboration of nearly 20 yearshttps://caliceos.com
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Pdg, Co-Fondateur, Consultant SéniorCaliceos ConsultingToulouse, Occitanie, Fr
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Pdr, Co-Founder, Senior ConsultantCaliceos Consulting Jan 2020 - PresentToulouse, Occitanie, France -
PdgCimenio Consulting Jan 2019 - PresentToulouseProvide expertise, leadership and support in all matters relating to domestic and international Regulatory Affairs and Quality Management Systems for medical devices : - Geographical expansion- Life cycle management (including PMS and Vigilance)- Implementation of new standards / regulation (e.g. MDR 2017-745, …)- Clinical and Biological Evaluation process- Risk Analysis-... -
Executive Director Regulatory Affairs And ClinicalAllergan Jan 2007 - Jan 2019Paris, FranceExecutive Director Regulatory Affairs and Clinical 2015-2018 :Director of Regulatory Affairs and Clinical 2007-2014 :- Develop Regulatory Affairs organization and processes, recruit, train, manage and take responsibility of Regulatory Affairs staff (team of 8 collaborators through an OPEX organization with the support of consultants). Budget responsibility (500 k€)- Provide regulatory leadership across ALLERGAN Global organization (Expertise in Combo &Class III Medical Devices)- Act as the contact person of the legal manufacturer for Health Authorities, and provide support for audits/inspections (ANSM, GMED, PMDA, US FDA, ANVISA, KFDA, CFDA, etc.)- In charge of registration activities (EU, US, Japan, China, Australia, Brazil...) and maintenance of licenses (Portfolio of 450 licenses)- In charge of regulatory compliance for the site and products (notably defined the implementation plan for the European Device Regulation 2017/745)- In charge of clinical evaluation report management (10 CERs) and of their transition to MEDDEV2.7.1, rev. 4.- Responsible for submission and approval of clinical studies in EU (5 studies)- Develop the risk management process according to ISO 14971:2007 and ensure the implementation of its 2012 version in collaboration with QA- Create the PMS process and co-lead PMS activities with QA- Participate to QMS transition to ISO 13485:2016 and co-lead with QA MDSAP program implementation- Initiate improvement of complaint management and the implementation of a "SIGNAL DETECTION" process- Quality auditor -
Executive Director Regulatory Affairs And ClinicalCorneal Nov 1995 - Dec 2006Paris, FranceTechnical and Commercial Director 2003-2006:- In charge of aesthetic unit- Head of French sales team (8 collaborators)Director of Regulatory and Clinical Affairs 2000-2006:- Create and lead the clinical department (5 clinical investigations: glaucoma implant, IOLs, OVDs)- In charge of WW registrations (EU and International)- In charge of reimbursement activities- Create and implement the change control process - Create and develop regulatory / standard monitoring process- Obtain the CE mark of Juvederm range with Lidocaine (1st range with lidocaine on the market).Manager Regulatory Affairs 1995 – 2000:- Create and lead the regulatory department within the framework of the MDD 93/42/CE implementation (More than 10 CE certifications obtained: LIOs and OVDs- In charge of vigilance process- Interim Resp. pharmacist
Catherine Chaudron Education Details
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Université Paris V, PharmaciePharmacy
Frequently Asked Questions about Catherine Chaudron
What company does Catherine Chaudron work for?
Catherine Chaudron works for Caliceos Consulting
What is Catherine Chaudron's role at the current company?
Catherine Chaudron's current role is PDG, Co-fondateur, Consultant Sénior.
What schools did Catherine Chaudron attend?
Catherine Chaudron attended Université Paris V, Pharmacie.
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