Clinical Trail CMC

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, M.Sc. Senior Director, Regulatory Science, Clinical Trials

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, Pharmacist Ph D. Senior Director, CMC & Quality and Qualified Person

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.

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