SHORT-BIOGRAPHY

Cornelia Camara, MSc Biochemistry

Cornelia is a biochemist with over 20 years experience in the pharmaceutical and biotechnology industries and over 10 years of experience in the field of medical devices. Cornelia graduated from the University of Geneva/Switzerland with a Masters in Biochemistry and holds a licence degree in chemistry from the University of Lausanne/Switzerland.

She held several positions in major pharmaceutical and biotech companies such as

• Ares Serono (Merck-Serono), where she supervised a GMP-compliant quality control laboratory, developed analytical methods and SOP’s and was actively involved in the planning and reporting of stability studies of biotechnology products.
• Sanofi-Synthélabo (Sanofi-Aventis), where she was Regulatory Affairs Officer in the field of neurology and responsible of the Swiss territory in coordination with the French Headquarters.
• Debiopharm, a Swiss drug development company specializing in oncology and in reformulation of drug products, where she coordinated the licensing-in department and was involved in all aspects of the drug development process from preclinical to clinical stage, marketing authorisation strategies as well as business aspects.

In the year 2006 she started regulatory affairs consultancy by coaching and training start-up companies in the Scientific Park of the Polytechnic School in Lausanne (Switzerland), where she acquired competences in regulatory strategies for the development of medical devices and drug/medical device combined products.

Since then she has been acting as a regulatory advisor mainly for small to mid-sized companies to provide them support in regulatory affairs, manufacturing and quality aspects of drug and device development, in marketing authorisation submissions and medical device European CE-marking.

Since the year 2014, when Camara And Partners implemented the clinical research activities, Cornelia is also active in clinical operations and responsible of clinical trial quality assurance.

Cornelia is a Swissmedic accredited Qualified Person.