Dr. Brigitte Friese is an attorney and gained her legal Dr at the University of Passau, Germany. Since 1991 she has specialised in the field of German and EU pharmaceutical law. She first worked as a lawyer in the pharmaceutical industry, first as inhouse lawyer at Henning Berlin GmbH (now Sanofi-Synthelabo) and Schering AG, Berlin, Germany. Since 1993 she works as lawyer in her own office and specialises in the advise of pharmaceutical companies of all sizes regarding all aspects of pharmaceutical law.

Dr. Brigitte Friese is author of numerous articles relating to pharmaceutical law and was editor and co-author of the “Handbuch der EU-Zulassung“, of which Part A of the “Guide to Drug Regulatory Affairs“ is the extended successor.

email: friese@friese-lawfirm.de

Dr. Barbara Jentges is a Pharmacist and gained her PhD at the Eberhard-Karls- University of Tuebingen, Germany. Since 1991 she has been working as an expert/ assessor of the Federal Institute for Drugs and Medical Devices (BfArM = Bundesinstitut für Arzneimittel und Medizinprodukte) in Bonn, Germany.

From 1991 to 1999 she owned a pharmacy, obtaining a manufacturing licence and becoming certified as a "Qualified Person". From 1997 to 1999 she was nominated a honorary inspector ("Pharmazierat") of public pharmacies in Germany. From January 2000 to June 2006 Dr. Barbara Jentges worked with Concept Heidelberg, Germany, as a project manager, specialized in GMP for APIs (Active Pharmaceutical Ingredients) and regulatory affairs. Since November 2006 she has run her own business in the regulatory affairs field.

email: barbara@jentges.com

Dr. Usfeya A. Muazzam did his doctorate in Pharmaceutical Technology at the Institute of Pharmaceutical Technology of Philipps University in Marburg, Germany. Since 1981 he is working with the Federal Institute of Drugs and Medical Devices (BfArM = Bundesinstitut für Arzneimittel und Medizinprodukte) in Bonn, Germany.

At the present Dr. Usfeya A. Muazzam is working as Senior Assessor for Quality, Division: Quality, Department: Scientific Quality Assurance, Staff Unit: Strategy and Planning of BfArM. He is co-author of "Gute Regulatorische Praxis, Arzneimittelzulassung - Pharmazeutische Qualität", Wissenschaftliche Verlagsgesellschaft, Stuttgart, Germany.

email: u.muazzam@t-online.de

Further authors of special contributions

Sven Harmsen
Senior Consultant
e-DRA Harmsen
email: sharmsen@e-dra.com

Dr. Susanne Keitel 
Strasbourg
email: s.keitel@arcor.de 

Dr. Chris Oldenhof
Manager External Regulatory Affairs
DSM Anti-Infectives (The Netherlands)
email: chris.oldenhof@dsm.com

Dr. Klaus Olejniczak
Head of the Genotoxicity and Reproductive Toxicology Unit
BfArM (Federal Institute for Drugs and Medical Devices, Germany)
email: K.Olejniczak@bfarm.de

Dr. Henrike Potthast
Pharmacist; substitutional Head of the Department Biometrics/Statistics/BE/BA
Responsibility: internal and external questions on Bioequivalence/Bioavailability/Biowaiver
BfArM (Federal Institute for Drugs and Medical Devices, Germany)
email: h.potthast@bfarm.de

Dr. med. Joachim A. Schwarz
Physician (internal specialist, clinical pharmacologist)
email: joachimschwarz.jas@web.de

Dr. Barbara Sickmüller
Deputy Director General of the German Pharmaceutical Industry Association, BPI (Germany)
email: bsickmueller@bpi.de

• Dr. Jenny Müller
  Scientific Officer Clinical Trials
  Medical Research Council, The Gambia, West Africa
  email: jmueller@mrc.gm

Contributions related to Switzerland

Dr. Dorothee Heer
Pharmacy of Swiss Armed Forces
Head of Regulatory Affairs
email: dorothee.heer@bluewin.ch

Dr. Thomas A. Keller
Formerly Swissmedic - Swiss Agency for Therapeutic Products

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