Quality accreditation for medical research at Universities | 1860
Journal of Developing Drugs

Journal of Developing Drugs
Open Access

ISSN: 2329-6631

Quality accreditation for medical research at Universities

2nd International Summit on GMP, GCP & Quality Control

November 12-14, 2013 DoubleTree by Hilton Hotel Chicago-North Shore, IL, USA

Brigitte Von Rechenberg

Scientific Tracks Abstracts: J Develop Drugs

Abstract :

Universities used to focus on academic careers and (basic) science not necessarily closely related to applied medical clinical problems. This changed over the last two decades considerably and meanwhile universities encourage technical innovations through various measures such as transfer offices dealing with contracts between researchers and companies, but also by providing infrastructure and space for spinoff companies. Furthermore, promotion of young talented researchers is attempted as well as closer contacts between academic institutions and industries. Last but not least Universities and National funding agencies encourage priority programs promoting applied research and include industrial partners as primary partners. There, industrial partners are also beneficiaries for funding by governmental agencies. This development is true for most countries. In fact, the European Commission has several sustainable programs that are very successful not only in academic outputs, but also in practical implementations and product development. This development also raises questions of quality management at Universities. Issues concerning official registration of medical products that follow the guidelines of the OECD (medical devices) or FDA need to be addressed especially if dealing with regenerative medicine and there, development of various biomaterials, composites and/ or tissue engineered organ/tissue replacements. Translational medicine comprises the full cycle of original innovation, product development, preclinical animal trials, up-scaling of products and finally clinical trials with human patients. It includes also regulatory issues such as GMP, GLP and GCP. The UZH is one of the first European Universities that created such a platform offering GMP, GLP and GCP at the same institution.

Biography :

Brigitte Von Rechenberg is a professor of experimental surgery at Vetsuisse Faculty, University of Zurich, Switzerland and is the head and founder of MSRU as well as the head and one of the founders of the CABMM, a platform dedicated to translational medicine. She also belonged to the founders of the European College of Veterinary Surgeons and was one of the former presidents of the European Board of Veterinary Specialization. She dedicated her professional career to quality management in animal surgeries and is also president of the Ethical Commission for Animal Experiment in the Canton Zurich, Switzerland. She has developed several standardized animal models in musculoskeletal research with minimal harm to animals and maximal output for research results. In addition, she is the author of >117 peer reviewed original research publications and is an international well known speaker in >200 conferences. She was recently elected as the first female Dean of the Vetsuisse Faculty ZH, starting her term in August 2014, now acting as a Pro-Dean since 2010.