Regulatory Affairs and CMC Conference

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 Master’s degree in Drug Regulatory Affairs.

Senior Expert in Regulatory Affairs with a high level of expertise in European approval procedures (esp. MRP & DCP) and simplified procedures

Keine ausführliche englische Beschreibung vorhanden

Blanka Hirschlerová is working in the State Institute for Drug Control in Prague, she started as pharmaceutical assessor, currently she is director of the Department of Pharmaceutical Assessment for chemical and herbal products.

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.

In the past, she held - among other things - the position of deputy head from 2015 to 2020 and until 2022 the comm. Head of the German GLP Federal Office at the Federal Institute for Risk Assessment (BfR) and was technically responsible for the accredited laboratories of the BfR including the NRLs located there. She has extensive experience from industry, the public sector, research, universities and institutions in Germany and abroad (Germany, Singapore, China). Since August 2022, Dr Hunke has been working as GLP-QA and as a consultant at DiQualis Germany with expertise in ISO and regulatory GxP requirements as well as laboratory-related computerised systems (LIMS, eSignature, ELN, eDMS).
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