Outsourcing in Clinical Trials: Medical Devices Europe

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Session Details: Brexit: What does it mean for Medical Device professionals? 06-02-2020, 1:45 pm View In Agenda

Biography: Beate has over 18 years of experience in leading clinical research departments. After building up and managing the AO Clinical Investigation and Documentation institute for many years, she moved to S&N in 2015 as the Regional Clinical Director for EUCAN. Beate was appointed the Head of Global Clinical Strategy, Senior Director in October 2015, and became a Vice-President in March 2016. She also serves as an Assistant Professor at the University of Washington, School of Public Health in Seattle, USA, and is a Visiting Professor at the University for Human Science in Liechtenstein. M.D. from the Benjamin Franklin University of Berlin, Germany. M.P.H. from the University of Washington.

Session Details: Big data and data mining 05-02-2020, 12:00 pm View In Agenda

Biography: Dr. Goetz is an accomplished clinician, scientist, and cardiac surgeon with a decade of clinical experience. He combines profound practical experience with his passion for curing heart valve disease. His main interest is developing innovative treatments for structural heart valve diseases. He started his career as a cardiac surgeon at the University Hospital in Regensburg, Germany. After continuing clinical practice in Germany, Dr. Goetz went to Singapore in 2005-2006 to lead a research project for developing a surgical autologous heart valve prosthesis that is made from a patient’s own pericardium. This priceless valve prosthesis was implanted in humans in Asia. In 2005 he founded EndoCor Inc. in Singapore for the development of percutaneous heart valve prostheses. Back in Germany, Dr. Goetz worked at the German Heart Center in Munich. Within one year he qualified as an associated professor (Habilitation). At the same time, he did set up a clinical trial for the implantation of transcatheter heart valve prostheses. Having gained comprehensive knowledge in cardiac surgery, the development of heart valve prostheses and, finally, the new technology of transcatheter heart valves, he decided in 2009 to give up a very successful career as a cardiac surgeon and to start-up Transcatheter Technologies GmbH to develop a transcatheter heart valve system that is designed to increase the safety and durability of aortic valve implantation. The proprietary technology was acquired by Venus Medtech (Hangzhou, China) in 2016. Afterwards, Dr. Goetz became Partner of medifundo Life Science Investments. In 2018 Dr. Goetz founded Prima Medical Technologies GmbH and spun-off three technology companies: Artract Medical, Semiflow Medical and Venock Medicial Inc. in the USA with the subsidiary Venock Medical GmbH, in Germany

Session Details: Panel Discussion | Selecting the perfect clinical site: Reduce expenditure and save time 05-02-2020, 2:00 pm View In Agenda

Biography: John Shillingford, PhD is an experienced clinical researcher whose career in the Pharmaceutical, Medical Device and CRO industries has stretched over 40 years.  John has both lived and worked in a number of European Countries as well as the USA.   He is now lives in Germany. His wide experience of Drug and Medical Device Development in Europe and the USA has been acquired during the management of both Clinical and Data Operations for major Global Programmes. John has held senior positions in Management, Clinical Operations and Project Management for, Aptiv Solutions, Averion International (a Medical Device Research Company), PRA International and Imform GmbH. Currently John is Clinical Operations Director and a member of the Board of Afon Technology Ltd, a UK based Medical Device Company, Consultant to International Research Companies  and additionally continues to run a number of training courses in Vendor and Project Management.

Session Details: CASE STUDY | Managing disputes among sponsors and vendors 05-02-2020, 10:00 am View In Agenda

Biography: Sabine Hauck is Vice President Research & Development at Munich-based biotech company LEUKOCARE. She has 20 years of experience in biotech industry, in which she held various positions in development, quality assurance and regulatory affairs. For about 10 years during this time she was responsible for clinical trial materials that consisted of a Medicinal Product and a Medical Device, and during this time she acquired a lot of experience in the use of Medical Devices in clinical trials and in development of combination products. In the current position Sabine Hauck is responsible for R&D activities at LEUKOCARE AG. In this role she oversees the customer projects and internal development projects including the algorithm-based formulation development approach at LEUKOCARE AG.

Session Details: Artificial Intelligence in Development of Stable Biologics Formulations 05-02-2020, 3:45 pm View In Agenda

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Catrin Argyle is a Senior Clinical Research Associate at Ava AG in Switzerland. Ava AG is a digital women`s health company with a mission to advance women`s reproductive health by bringing together artificial intelligence and clinical research. Catrin joined the company in 2018 and is involved in the management of clinical trials for wearable medical devices. Her work involves exploring novel methodologies to increase clinical trial efficiency whilst maintaining quality and compliance. In addition to this, Catrin has experience with EU medical device submissions and MDR compliance.

Catrin has a background in the pharmaceutical industry, having previously worked in site management on phase II/III trials at IQVIA. Catrin holds an MSc in Reproductive Science and Women`s Health from University College London.

Session Details: How the adoption of digitalisation can increase the efficiency of clinical trials? 06-02-2020, 11:00 am View In Agenda

Biography: Metissia has 9+ years of experience within the Pharmaceutical and Medical Device Industry (including the following roles: Medical Information, Quality assurance and Regulatory affairs) She worked for Philips Imaging guided therapy businesses in Netherlands/Belgium and Arkray Europe B.V (current position).

Session Details: Panel Discussion: IVDR registration and obstacles / challenges 06-02-2020, 12:00 pm View In Agenda

Biography: Dr. Torsten Böhler studied Biology at the University Konstanz, Germany. From 1996 to 2008, he conducted investigator initiated studies at Charité Hospital Berlin and at the University Hospital in Toulouse and worked as a visiting scientist at Stanford University (USA) and as a postdoc researcher at INSERM (France). He was awarded for his clinical research by the American Transplant Society and by the European Society of Organ Transplantation. From 2008 on, Torsten joined the medical device industry and organized at R&D Gambro clinical investigations with a new generation of dialyzers (Class IIb medical devices) in patients with chronic kidney disease. From 2013-2017 he successfully continued this work with Baxter as a global acting clinical project manager leading interdisciplinary study teams, facilitating  CE registration/ launch of the new developed Theranova - dialyzer. Since January 2017 Torsten is Head of Clinical Affairs at Straub Medical AG, a Swiss manufacturer of endovascular medical devices (Class III). In this position Torsten is responsible for all clinical data collections to support regulatory affairs,  R&D and reimbursement activities.

Session Details: Benchmarking techniques to administer proactive post-market surveillance 05-02-2020, 9:00 am View In Agenda

Biography: Dr. Miguel Hernandez is a general physician with postgraduate studies in the field of clinical and medical Bioethics. He has been involved in the area of clinical research mainly focused on Medical Devices over the past 12 years, where he has been responsible for pre-market safety reporting and post-market surveillance across Europe, U.S.A., Canada and Japan. His main area of therapeutical expertise include orthopedics, interventional cardiology, CNS, dermatology, rheumatology and women’s health. He has worked in diverse roles across the industry, including medical device companies and CROs, in roles such as  Safety Officer and Medical Management, Clinical Research Physician, Medical Device Safety Manager, Head of Materiovigilance, and is currently working as Medical Device and Safety Surveillance Lead for UCB,  where is heavily involved in the transition from the Directive 2007/47/EC to the MDR (2017/745) in order to meet regulatory compliance.

Session Details: Roundtable 1: PMS Requirement and the transition to the MDR 06-02-2020, 9:00 am View In Agenda

Biography: Stephan Theinert holds a Ph.D. of the Charité - University Medicine Berlin, Germany in immunology since 2007. He studied biology at the Humboldt-University in Berlin, Germany with an emphasis on microbiology, genetic and biochemistry. In 2006 he joined the PAREXEL GmbH in Berlin, Germany as a project manager clinical phase I. In 2008 he joined the Momentum Pharma Services GmbH in Hamburg, Germany as a manager business development. In 2009 he became director business development. Since end of 2009 he, as Head Clinical Affairs, was mainly responsible for the clinical studies incl. parts of regulatory and medical affairs. In 2018 he become Head of the newly established department Clinical Development.

Session Details: Roundtable 2: Overcoming challenges medical devices start-ups face when conducting clinical trials 06-02-2020, 9:00 am Best methods for a prosperous sponsor/vendor relationship management 06-02-2020, 3:45 pm View In Agenda

Biography: Paul Swinckels is the Chief Commercial Officer (CCO) at LifeSense Group who has more than 20 years of experience in Electronic devices and since 2017 in the wearable medical devices technology. Paul knows how to bring added value to the customers and bring the needs into the right solution for the end user. Paul worked for 17 years in the high-end technology segment at GE in Western Europe which was acquired in by United Technologies later. With the experience of and partnering with private and government hospitals, clinics, Doctors and multi nationals, he provides the right solution for the real needs of the patients.

Session Details: Wearable devices and innovations: a model for connected technology 05-02-2020, 11:00 am View In Agenda

Biography: My name is Joseph Zhou. I am the founder of Hongzhi Medical Device Technical Co., Ltd. I bought Cardiosignal GmbH in Dec 2018. Now we are applying for CFDA and CE for our latest Mechanical Heart Valve Monitor. We are doing research for our new device Heart Failure Monitor. What's more, we will doing research for Artificial Heart Monitor. All 3 household devices are very small and easily used. We focus on developing new cardiology household medical devices.

Session Details: Case Study | Advantages and challenges of conducting clinical trials in China 06-02-2020, 3:15 pm View In Agenda

Biography: Priv.Doz.Dr. Roman Gottardi, MBA, FECTS Consultant Cardiac Surgeon at the Mediclin Heartcenter Lahr/Baden Germany. Special clinical focus on open and endovascular treatment of aortic disease has participated in several clinical trials as principal investigator. Founder and managing director of TEVAR Ltd, a start-up developing a novel non-occlusive stent-graft molding balloon.

Session Details: Panel Discussion | Selecting the perfect clinical site: Reduce expenditure and save time 05-02-2020, 2:00 pm View In Agenda

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Session Details: Examining the new Post-Market Surveillance (PMS) and the risk management process 05-02-2020, 4:15 pm View In Agenda

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Session Details: A joint approach to delivering clinical research 05-02-2020, 12:30 pm View In Agenda

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Session Details: A joint approach to delivering clinical research 05-02-2020, 12:30 pm View In Agenda

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Angela has over 20 of regulatory affairs and quality assurance experience with various products in the medical device industry specializing in international regulatory affairs working with universities, start-up and blue chip companies.  Her expertise reflects her ability to successfully navigate country specific requirements by providing strategic global regulatory strategies and submissions bringing new and existing products to the marketplace outside the US including EU, Canada, South & Latin America, Middle East, Asia, and Africa, as well as the US. She is experienced in transitional regulatory activities to handle the ever-changing global regulatory environment.  Angela has a comprehensive knowledge of the regulations for the preparation and writing required for global medical device submissions including EU Technical Documentation (Technical Files/Design Dossiers), Canadian Licensing and Submissions, TGA Technical Documentation, International Product Dossiers, and JSTED, as well as US premarket submissions. Additionally, her expertise in quality assurance provides quality management system alignment as additional geographic regions are incorporated, specifically in post market activities including complaint management, adverse event reporting and recall management.  Angela has held various levels of responsibility in regulatory and quality throughout her career prior to joining ICON in 2018.  She is an active member of the Regulatory Affairs Professional Society (RAPS), The Organization for Professionals in Regulatory Affairs (TOPRA), and holds a B.S. in health science from Campbell University. 

Session Details: IVD regulatory landscape: challenges to prepare for before 2022 06-02-2020, 11:30 am View In Agenda

Biography: After graduation as biologist, MSc. Kirsten started her career in clinical research. During the last 18 years, she gathered vast experience in conducting clinical trials, from CRA to PM, from Pharma to Medical Devices. Her main therapeutic experience lies within the cardiovascular field with special focus on interventional cardiology. Therapeutic areas Kirsten is also very familiar with are CNS and orthopedics amongst other indications. Since 2013, she operates exclusively in the field of medical devices – being a global project manager for pre- and post-market studies conducted mainly in Europe, US and Asia Pacific. Next to her PM role, she was also involved in several other activities e.g. medical writing, site auditing, regulatory activities and acted as trainer for sites and CRO staff. She is a regular speaker at congresses and summits. Currently, Kirsten’s main role is acting as a program oversight manager for a study program of numerous single studies, hence ensuring streamlined communication pathways and homogenized approaches to guarantee most the efficient program results.

Session Details: PMCF study or registry: where to draw the line? 05-02-2020, 9:30 am View In Agenda

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Session Details: Post-Market Clinical Follow-up: what do we need to do and can we do it? 05-02-2020, 11:30 am View In Agenda

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Session Details: Roundtable 3: Effective vendor selection and vendor management in clinical trials with Medical Devices 06-02-2020, 9:00 am View In Agenda

Biography: Judith Koehnen is Director Project Management of Covance’ Device and Diagnostic Solutions Business Unit. She has 24 years industry experiences with over 21 years in the CRO environment and over 16 years in the Medical Device arena. Judith has been in leadership roles in Project Management and the Medical Device Business unit. She has been responsible for Global Medical Device Training initiatives across all functions at Theorem and Chiltern now Covance and SOP revision in order to comply with Medical Device requirements and terminology across the globe. Currently she is leading the trainings initiative for the upcoming Medical Device and In-vitro Diagnostic Regulation. From 2012 – 2015 Ms. Köhnen was co-chair and from 2015 – 2016 chair of the European CRO Federation Medical Device Working Group.

Session Details: Impact of a no deal Brexit on your Clinical Investigation & CE mark 06-02-2020, 2:15 pm View In Agenda