Senior Director, CMC & Quality
Philippoz, Pharmacist Ph D.
and Qualified Person
Florence Philippoz is responsible for the management of projects involving the development of Chemistry Manufacturing and Control (CMC).
She heads up the activities of the CMC group built to provide assistance to product development with a staff combining strong technical background with good regulatory expertise. Her experience in the pharmaceutical industry allows Florence to interface efficiently with the technical and regulatory teams and help coordinate CMC activities in line with the product development phases.
With a strong industrial experience in Quality Assurance, Quality Control and Analytical Development, Florence contributes actively in the elaboration of product development plans and participates in the preparation of supportive documents such as stability and validation reports, process optimization/development reports. Florence also provides support to technology transfer for both processes and methods. Combining strong scientific, technical and regulatory knowledge, Florence is able to anticipate the impact of development strategies on subsequent submissions which presents a key asset to product development.
Florence is actively involved in reviewing and preparing regulatory pharmaceutical documents (CMC sections of IMPD/IND, IB and Clinical Protocols, Briefing Packages for Scientific Advice, CTD Module 3, and Quality Overall Summary of MAA/BLA) and participates in Agency Meetings to discuss CMC questions and strategy at different stages of development.
In addition, Florence acts as a Qualified Person in Switzerland (Responsible Person). In this role, she is involved in the submissions of several Marketing Authorisation Applications for Drugs in Switzerland and interacts regularly with Swissmedic. As such, she maintains good knowledge of Swissmedic procedures and Swiss regulations including Good Manufacturing and Good Distribution Practices.
Florence also acts as a QP for other companies located in Switzerland. She establishes, maintains and supervises the quality management system of these companies. She assumes the responsibility for pharmaceutical activities in relation to the Establishment Licences (importation, wholesale and trade abroad). Florence is responsible for the direct technical supervision of the facilities, decides to release or reject batches, author quality contracts, perform GDP audits, manages deviations, complaints and is the main contact point for Swissmedic for quality aspects (e.g. inspections, recalls etc…).
Florence graduated from the University of Angers in France and worked for 4 years in several hospitals in Paris as in-house pharmacist. She completed her industrial pharmacist diploma with a specialization in analytical chemistry.
Florence brings 20 years of international experience in the Pharmaceutical Industry including 3 years at Pasteur-Merieux, France, and 12 years at Debiopharm, a global Swiss-based Biopharmaceutical Development Company. At Debiopharm, she was in charge of the Quality Control and Analytical Development of products such as antiviral, neurology, pulmonary and oncology molecules. In this role she gained significant experience in chemistry of small molecules, analytical development and validation, specification set-up as well as stability testing.
Florence brings strong pharmaceutical development knowledge for chemical drugs from her past experience. At VCLS, Florence also gained a significant expertise in peptides development.