Regulatory Affairs and
CMC Conference

Head Regulatory Operations
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Member of the Management Board (Medical and Scientific Affairs), Head of the Drug Authorisation Department; Since March 2006, Britta Ginnow has been working as the Head of the Drug Authorisation Department at the Federal Association of the Pharmaceutical Industry (BPI) e.V. Her main responsibilities include national and European authorisation and maintenance procedures, which also encompass electronic submissions. Further focal points are regulations concerning patient and product information leaflets, the use of digital media for these purposes, the classification of medicinal products, and environmental risk assessments in the context of marketing authorisations. Ms Ginnow holds a degree in Food Chemistry and began her career in the pharmaceutical industry in 1998 in the fields of product development and authorisation of medicinal products at a contract manufacturer for soft gelatine capsules. From 2001, she worked in Regulatory Affairs at two other companies, managing the authorisations for products marketed nationally and internationally. She completed a part-time Masters degree in Drug Regulatory Affairs.

Regulatory Affairs Specialist

After studying pharmacy, Marcus Savsek worked in the development department of Madaus AG. Since 2001, he has been an assessor for the approval of chemically defined medicinal products and, since 2018, has been deputy head of department in the Neurology, Psychiatry and Ophthalmology Department at the Federal Institute for Drugs and Medical Devices in Bonn. For many years, he has been an expert and trainer on regulatory topics related to pharmaceutical quality and pharmacokinetics, has been involved in the preparation of relevant guidelines, and holds a lectureship at the University of Nicosia.

Department Regulatory Affairs, Institute for Marketing Authorisation of Medicinal Products & Lifecycle Management Angela Schütz, MA is a regulatory service expert at Austrian Agency for Health and Food Safety, with more than twenty years of experience in lifecycle management and with new applications. She has a strong background in regulatory skills and expertise for new application. She is committed to always stay up to date and to implement procedures in partnership as quickly as possible. Angela Schütz has a Master's degree in "Leadership, Politics and Management" from the FH Campus Favoriten, Vienna and a discontinued degree in veterinary medicine in the final stage.

Head Regulatory API/AI

Head of AMG, GMP inspections, MPG After studying pharmacy and obtaining his doctorate, Arno Terhechte worked for five years in the pharmaceutical industry in the (inter)national marketing authorization and quality control divisions, most recently as deputy head of inspection. In 1998 he took over the task of monitoring pharmaceutical manufacturers at the Düsseldorf district government, and since 2003 he has been responsible for this at the district government in Münster (including medical device manufacturers/operators). Dr Terhechte is head of the expert group 11 "Computerised systems" and a member of the "Information Technology" section of the Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V. (APV).