Speakers

Speakers confirmed so far:

	Dr Cornelia Bodinet Schaper & Brümmer, Germany Head of Division “Pharmaceutical Laboratories” Cornelia studied Biology with focus on microbiology at University of Saarbrücken and University Greifswald, Germany. Since 1986, she is at Schaper & Brümmer and today she is head of Division “Pharmaceutical Laboratories” and a member of the management board.
	Marieke van Dalen Aspen Oss, The Netherlands Global regulatory specialist Marieke is the global regulatory specialist in the regulatory group dedicated to APIs, with almost 30 years of experience in the regulatory field. She is a board member of APIC, the European API Industry organization, and she participates in the Japan task force, Emerging markets task force and the Quality metrics task force. She frequently represents APIC in meetings and conferences organized by EMA, EDQM, ICH etc.
	Sergio Fracchia Novartis, Switzerland Reg CMC Ass Dir CGTU Sergio presently works as Associate Director RegCMC – Cell and Gene Therapy at Novartis. He is presently RegCMC representative for the development of several gene therapy and gene editing investigational medicinal products at different stage of development.
	Dr Annick Gervais UCB, Belgium, UCB Pharma Director of Physico-Chemical Method Development Annick is Chemical engineer by education and Doctor from University Louis Pasteur (Strasbourg, France). She is currently Director of Physico-Chemical Method Development in Analytical Sciences for Biologicals in UCB Pharma (Braine L’Alleud, Belgium) dealing with development, validation, transfer of methods and process support from early phase to life cycle management for therapeutic proteins and monoclonal antibodies in the field of immunology. She is also representing UCB in European Biopharmaceutical Enterprises (EBE) biomanufacturing working group (part of EFPIA).
	Dr Gerd Jilge Boehringer Ingelheim, Germany Member of the ECA QC Group In 1991 Dr Gerd Jilge joined Boehringer Ingelheim working in product development where he was responsible for method development and validation for the application of analytical procedures. In 2000 Gerd took a position in Drug Regulatory Affairs of Boehringer Ingelheim with the focus on CMC documentation for the submission of new and registered drug products. Since July 2007 he is working in Quality Control on topics like method transfer as well as method optimization and validation for active drug substances. In 2014 Gerd became a member of the EDQM expert group 11.
	Dr Ingrid Mecklenbräuker Novartis Pharma Stein, Switzerland QC Lab Coordinator Ingrid Mecklenbräuker studied biology at the University of Vienna with focus on microbiology and genetics and earned her PhD in genetics at the University of Cologne. After postdoctoral studies at the Rockefeller University in New York, she worked as a scientist at the Albert-Ludwigs-University Freiburg and co-founded in 2007 a start-up company for development of novel antibiotics against multidrug-resistant pathogens. In 2011 she joined Eurofins \| GeneScan GmbH where she was involved in building up the microbiological division and validation of new molecular detection methods for pathogenic microorganisms in food. In 2013 she joined Novartis Pharma Stein AG as QC Lab Coordinator (Non-sterile Drug Products).
	Dr Jennifer Purdie Eli Lilly, USA Consultant Engineer Jennifer studied Chemical Engineering and Chemistry at the Universities of Notre Dame and Indianapolis. After working as Process Engineer at National Starch and Chemical, she joined Eli Lilly in 2001 as QA Representative. Since 2006 she is Associate Senior Consultant Engineer.
	Dr Johannes Reich MicroCoat Biotechnologie, Germany General Manager Johannes holds a PhD from the University Regensburg. He focused his research on the aggregation and interaction behaviour of lipopolysaccharides as well as the related activity in limulus based detection systems. In 2016, Johannes joined Microcoat Biotechnology GmbH and has recently been appointed General Manager. Johannes Reich also received a degree in Business administration from University of Applied Science in Regensburg, Germany. While pursuing his degree, he worked as Product Manager for the department “Drugs of Abuse” at Profos AG.
	Christoph Mück Quality Assesor Biological Drug Products Christoph studied pharmaceutical engineering and held an M.SC in Biomedical Engineering. Before he joined the Austrian Agency for Health and Food Safety, he worked 6 years in pharmaceutical companies with responsibilities in Process Validation and Quality by Design projects.for gene therapy and recombinant products.
	Dr Don Singer United States Pharmacopoeia/ GSK Biopharmaceutical GMP Ops Don Singer is a GSK Senior Fellow, an American Society for Quality Fellow and Manager, Biopharmaceutical GMP Ops at GSK. Don has been a member of the USP Microbiology Committee of Experts since 2000, and is currently Vice-Chair of the committee. He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and has been a Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 35 years of research, quality control, quality assurance experience in the pharmaceutical, cosmetic, and food industries. He is currently an adjunct instructor in the Biopharmaceutical Quality program at University of Maryland Baltimore County.
	Christine Weiß Labor LS, Germany Head of Quality Control Christine Weiß studied nutritional sciences and home economics at the Technical University of Munich. In 2006 she joined Labor LS where she worked first as head of department and some years later as division manager for microbial testing of non-sterile products . In 2018 she became head of quality control for the division of non-sterile product testing.
	Dr Ralf Klein Virusure Business Development Management Prior to his position at ViruSure he has worked at several other CRO´s (BioReliance, Invitrogen, NewLab BioQuality and Charles River Laboratories). At BioReliance he was a Study Director for virus validation studies for about 4 years before moving into the role of a key account manager for biosafety testing services. His subsequent positions at other CRO’s has been in business development / key account management. A graduate of the University of Heidelberg with a degree in Genetics, Microbiology and Biochemistry, he served for 4 years at the diagnostic laboratory Seelig establishing ELISA and PCR tests for virus and autoimmune diagnostics. He earned his Ph.D in virology at the German Cancer Research Centre in Heidelberg working on Hepatitis B Virus at the Institute for Applied Tumour Virology(headed by 2008 Nobel Prize winner Prof.Harald zur Haussen). Following his Ph.D., Ralf worked also as a post-doctoral fellow at the Institute for Applied Tumour Virology studying Tumor Suppressor Genes. Ralf holds a patent on a p53 ELISA test.