Lise Barbin

Lise Barbin

Senior Consultant, International Drug Development & Scientific Writing

Lise brings deep expertise in a broad range of clinical and regulatory documentation. She has been both directly involved in writing the full range of clinical and regulatory documentation as well as coordinating across a team of scientific writers and acting as the key contact for internal and external partners. She is also trilingual (French, English and German).

 

About Lise

Lise has considerable experience in a broad range of regulatory writing activities in various therapeutic areas (including oncology, neurology, ophthalmology, metabolic diseases, ENT). She works in close collaboration with life sciences companies to provide strategic input and regulatory writing for new MAA submissions or during the lifecycle of the product. Her recent client work includes:

 

Past experience

Before joining BlueReg, Lise worked in academia and the pharmaceutical industry.

 

After finishing a chemical engineering degree, she completed her PhD in biochemistry at the University of Stuttgart (Germany), and then performed as a post-doctorate at the Pasteur Institute in Paris (France).

 

During her time in the pharmaceutical industry Lise was involved in the writing of a wide spectrum of regulatory documentation, including clinical trial applications, investigator brochures, scientific advice packages, Orphan Drug applications, safety update reports and eCTD modules. She was also involved throughout the lifecycle of these documents including submission via the centralised procedure and responses to regulatory agency questions.

 

Lise has also held the position of Principal Regulatory Scientific and Medical Writer. In this role, she led a team of Medical Writing professionals, worked in close collaboration with cross functional internal and external teams and experts (pharmacovigilance, biometry, clinical, non-clinical, CMC, pharmacokinetics), and acted as a key liaison for regulatory activities.

 

Education

 

University of Stuttgart, Germany
PhD in Biochemistry (2010)

 

University of Stuttgart, Germany
Diplom Chemiker, Speciality Biochemistry (2005)

 

European Engineering School in Chemistry, Polymers & Materials, ECPM « Chimie Strasbourg »
Diplom of Trilingual Chemical Engineer ECPM, Speciality Analytical Chemistry (2005)

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