Lehrende

Dr. Gudrun Busch is an independent consultant for regulatory affairs. She began her career as a Clinical Research Manager for cancer therapy. She held leading positions in Regulatory Affairs and Quality Management with drug/device companies in Germany and Switzerland, e.g. with Beiersdorf AG, Hamburg. She was responsible for the management of clinical studies and regulatory affairs for drugs and medical devices. In 2004 she joined CSL Behring in Bern and introduced CTD and eCTD technique with regards to the biologics produced at the manufacturing site in Bern. Gudrun Busch has more than 20 years of experience in regulatory and clinical affairs of drugs, medical devices, combination devices, and biologics both for human and veterinary use. As a member of regulatory committees and trade associations she is involved in several working groups.

Dr. Alexandra Carina Gruber MBA MMFin has been working in the pharmaceutical industry for the past 14 years, where she has held various marketing and business development positions and developed a profound expertise in the marketing and licensing of biotech and generic products. She is currently Vice President of Marketing and Business Development at Biocrates Life Sciences AG. Alexandra Gruber holds a degree in Pharmacy from the University in Vienna and an Executive MBA degree jointly organized by the University of Business Administration and Economics, Vienna, Austria, and the University of Minnesota. In 2006, she started a postgradual program in Finance at the Danube University Krems together with the University of British Columbia (UBC), Vancouver. It was then that Alexandra Gruber discovered her interest in the field of venture capital and entrepreneurship for biotech startups, and this also became the focus of her master thesis. After finishing her studies, she decided to publish a detailed version of the results of her prospective, qualitative study in book format titled Biotech Funding Trends: Insights from Entrepreneurs and Investors (2009) to make her analyses available to a wider audience.
Homepage Alexandra Gruber

Arthur Hecht obtained a degree in Biomedical Engineering from the Technische Hochschule Mittelhessen, Gießen, in 1984 and immediately afterwards joined the pharmaceutical industry with Dr. Karl Thomae GmbH (which became Boehringer Ingelheim Pharma GmbH & Co. KG). After 2 years in preclinical development studying thrombo-embolic diseases with various animal models he gained 10+ years experience in human pharmacology developing noninvasive pharmacodynamic models. In 1997, he was appointed Head of Clinical Quality Assurance for the German unit. In addition to his regional, West Europe South, Quality Management responsibilities comprising Auditing, Compliance, SOP-Management and Training in Medicine and Regulatory he leads Boehringer Ingelheim’s global compliance in Medicine and Regulatory since 2010. Arthur Hecht is a registered EOQ (European Organization for Quality) Quality Systems Manager and Quality Auditor. In addition to his industry commitments he lectured on Documentation in the Pharmaceutical Industry at the Hochschule Hannover for more than 10 years.

Friedhelm Leverkus holds a masters degree in Statistics he obtained from the University of Dortmund. He started his professional career in 1988 at the Social Science Research Institute in Dortmund. In 1991 he joined Pfizer, working as a biometrician, and was appointed as Head of the Biometric Operations in 1995. The department was responsible for biometric support in planning, conduct, analysis and interpretation of all clinical trials and non-interventional studies sponsored by Pfizer Germany. In 2006 he became Senior Scientific Advisor. In this role he advises Medical Affairs, Outcomes Research, Evidence Based Medicine, and Legal on methodological issues.

Dr. Reinhard Nibler is a physician by training with board certifications in anesthesiology, emergency medicine, and medical quality management; he is also a TÜV Austria certified auditor. After clinical training, he started working in the pharmaceutical industry in 1998. After several positions in marketing, medical affairs, and clinical research, he finally took over the drug safety department of Essex Pharma in Munich. In this position, he also acted as Stufenplanbeauftragter according to §63 Arzneimittelgesetz (German Drug Law) and was a member of the national pharmacovigilance working group of the Verband Forschender Arzneimittelhersteller e.V. (vfa). In 2004, he founded his own company Dr. Nibler & Partner, a consultancy and service provider for all aspects of pharmacovigilance. He acts as a Qualified Person for Pharmacovigilance in the EU (EU-QPPV) for several companies, and is engaged in pharmacovigilance system audits and preparation for authority inspections. Reinhard Nibler is the president of the Mitteleuropäische Gesellschaft für Regulatory Affairs e.V. (MEGRA) and a regular speaker at, and course leader of, pharmacovigilance-related training courses.
Dr. Nibler & Partner

Dr. Birgit Ruhfus studied biology at the University of Bochum. After obtaining a diploma in biological sciences she moved on to the Max-Planck-Institute for Molecular Physiology in Dortmund to work on her PhD thesis on a topic in cell physiology. In 1996 she obtained her doctoral degree in natural sciences (PhD). Joining Schering AG in 1997, she started as a clinical auditor conducting all types of audits of studies and systems. In 1999 she spent a year at Schering’s U.S. affiliate to become acquainted with U.S. regulations while still working as compliance auditor in GCP and partially GMP as well. In August 2004 she moved on to Global Regulatory Affairs at Schering where she gained experience in submissions of clinical trial authorization applications, several types of variations, and extensions of clinical indications, mainly for centralized products. In July 2006, Birgit Ruhfus became head of Schering’s Global Clinical Quality Assurance function. After the merger of Schering with Bayer she became Head of GCP Study Audit Management – Europe in 2007. Today Birgit Ruhfus is responsible for overseeing the audit program for all Bayer Schering Pharma studies in Europe.

Dr. Thorsten Ruppert is Senior Manager for Research, Development, and Innovation with Verband Forschender Arzneimittelhersteller e.V. – vfa (Association of Research-Based Pharmaceutical Companies). In 2000 he obtained a PhD in Biochemistry from the Freie Universität in Berlin for his work on catalytic RNA in the study group of Andres Jäschke. He then started to work with NOXXON Pharma AG as a scientist in the Research & Development Department. He switched to clinical research and later became Manager of Scientific Marketing, Business Development. In 2003, he joined vfa where he is – beside other areas – responsible for clinical trials and plays a central role in the clinical research field in Germany in coordination/cooperation with the 45 member companies of vfa. In this regard he also closely works together with the German regulatory authorities and ethics committees.

After completing medical school at the Universität Münster, Germany, Thomas Trilling worked as a medical doctor in internal medicine at the Universitätsklinik Essen. About 12 years ago, he moved to the pharmaceutical industry and started his career as a sales representative before moving to the marketing department where he held various positions, including Cardiovascular Group Product Manager. In 2003, he joined Amgen GmbH as Business Unit Manager Nephrology, heading the sales and marketing unit, as well as running important product launches. Since 2007, he has been a general manager with Basilea Pharmaceutica Deutschland GmbH and has built up the company from scratch. The company introduced Toctino®, the most successful launch ever in dermatology, and it has been selected as the best company in dermatology in 2009 and 2010.

Axel F. Wenzel BSc MSc PhD FTOPRA has extensive experience in drug development with a focus on regulatory affairs (DRA). After leading the medical microbiology diagnostics laboratory at the Universität des Saarlandes, medical faculty in Homburg, he acquired his pharmaceutical expertise in a range of positions in drug development at the Novartis Research Institute (formerly the Sandoz Research Institute) in Vienna, Austria and at Merck Sharp & Dohme, Germany, progressing from bench researcher to Head of Project Management and New Drug Development. During the last 15 years, he has founded or cofounded and led several consultancies in the field of drug development (with a focus on DRA and pharmacovigilance), and he has been a founding and managing board member and the president (from 2006 to 2009) of The Organisation for Professionals in Regulatory Affairs (TOPRA), the largest such body in Europe. In addition, he was cofounder and, for more than five years, editor-in-chief of the journal TOPRA Regulatory Rapporteur, the largest EU-focused journal for DRA. He teaches at the Deutsche Universität für Weiterbildung as well as at the Universität Duisburg-Essen. He is the author of many publications, ranging from topical contributions in regulatory journals to contributions in scientific books and articles.
Pharma Scientific Services Team Topra Ltd
European Association of Pharma Biotechnology
EU Vigilance Ltd
Axel.wenzel@p-ss-t.de