Clinical Trials in the EU/EEA- Focus on CMC Aspects
Clinical trials testing the Benefit/Risk ratio of Investigational Medicinal Products (IMPs) in the European Union/European Economic Area (EU/EEA) are governed currently by Directive 2001/20/EC. This has led to different requirements amongst the Competent Authorities (CAs) and Ethics Committees (ECs) of each concerned MS.
Jilla Boulas, Delphine Decker, Valerie Pimpaneau, Florence Philippoz
2013 - Pharmaceutical Outsourcing
Delphine Decker, Director
She plays a major role in activities related to Clinical Trials Application and Project Management. She has extensive experience in projects involving the design and implementation of regulatory strategies for the clinical development and registration of drugs and innovative medicinal products.
Valérie Pimpaneau, Vice President CMC & Quality
Valerie Pimpaneau is responsible for the management of projects involving the development of CMC, bio-analytical and quality strategies for Drugs, Biologics, Gene and Cell Therapy. She heads up the activities of the regulatory CMC group built to provide assistance to product development with a staff combining strong technical background with good regulatory expertise. Her experience in the Biopharmaceutical industry allows Valerie to interface efficiently with the technical and regulatory teams and help coordinate CMC activities in line with the product development phases.
Florence Philippoz, Senior Director Regulatory CMC
She is responsible for the management of projects involving the development of Chemistry Manufacturing and Control (CMC). 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.
Jilla K. Boulas, Director CMC
Jilla assists clients in deciding the Regulatory submission pathway, product design/development and implementation of plans for pharmaceuticals and biologics, from the Chemistry Manufacturing and Control (CMC) perspective.