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Dr. rer. nat. Barbara Jentges

Senior Drug Regulatory Affairs & e-Submission Expert, Managing Director of Phact GmbH.

Phact Management Director Dr. Barbara Jentges

Barbara is a Senior Drug Regulatory Affairs Expert with over 30 years’ experience in drug regulatory affairs, particularly in the field of biotechnology pharmaceuticals, and an expert in e-submissions.

Since 2017, she has been teaching at the Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel AG) in Bern.

In the past, she also lectured at the ETH (Swiss Federal Institute of Technology), Department of Chemistry and Applied Biosciences in Zurich, Switzerland, in the Master’s programme Medicinal and Industrial Pharmaceutical Sciences (MSc MIPS) (from 2008 to 2022). She also lectured at the FHNW (University of Applied Sciences Northwestern Switzerland), School of Life Sciences, Muttenz/Basel, Switzerland (from 2011 to 2022) and at the Berne University of Applied Sciences (from 2018 to 2022).

She worked as an assessor of the German Federal Institute for Drugs and Medical Devices (BfArM).

Within the Parenteral Drug Association (PDA), Barbara was a member of the PDA Regulatory Affairs and Quality Advisory Board and served as European Co-Chair of the PDA Regulatory Affairs Interest Group.

She edited and co-authored the second edition of the book ‘Pharmaceutical Legislation of the European Union, Japan and the United States of America – An Overview’ (Second Edition 2016) published by Parenteral Drug Association, Inc., Bethesda, MD 20815, US.

Barbara studied Pharmacy at the University of Frankfurt/M., Germany and obtained a PhD in Pharmaceutical Chemistry from the University of Tübingen, Germany in 1990.

Co-Founder and Managing Director of Phact GmbH (since 2006).
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Assessor at the Federal Institute for Drugs and Medical Devices (BfArM), Germany,
according to §25.5 and §105 of the German drug law (AMG).
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Project manager (drug regulatory affairs, GMP) with Concept Heidelberg, Germany.
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Owner of a public pharmacy with a manufacturing license according to the German Drug Law (AMG); certified as ‘Qualified Person’ according to § 15 of German drug law (AMG).
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Member of the Curriculum Committee and lecturer of the Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel AG), Bern/Switzerland (since 2017).

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Lecturer at the Swiss Federal Institute of Technology (ETH) in Zurich / Switzerland in the Master´s programme “MSc Pharmaceutical Sciences” (2008 – 2022).
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Lecturer at the University of Applied Sciences and Arts Northwestern Switzerland (FHNW), School of Life Sciences, Institute of Pharmaceutical Technology, Muttenz /Switzerland (2011 – 2022).
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Lecturer at the Bern University of Applied Sciences, Bern / Switzerland (2018 – 2022).

Barbara Jentges (ed.), Denyse Baker, Takayoshi Matsumura, Joanne S. Hawana.
Pharmaceutical Legislation of the European Union, Japan and the United States of America – An Overview.
Updated and Expanded 2nd. Edition.
Parenteral Drug Association, Inc., 2013, 2016.
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Brigitte Friese, Barbara Jentges, Usfeya A. Muazzam.
Guide to Drug Regulatory Affairs.
Editio Cantor Verlag Aulendorf (Germany). 2009.
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Former European Co-Chair of PDAs Interest Group ‘Regulatory Affairs’.
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Former member of PDAs ‘Regulatory and Quality Advisory Board’ (RAQAB).
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IBM Professional Certificate Data Science
(program offered by IBM in collaboration with edX), including the following courses: