in the Asia-Pacific Region
A complex and continually evolving regulatory environment
The Asia-Pacific region is becoming increasingly attractive for global clinical development activities. There are numerous factors driving this trend, including a shortage of trial volunteers in Europe and North America, the sophisticated healthcare systems in many Asian countries, and the availability of highly trained medical professionals in the region. Equally important, Asia is the fastest growing pharmaceutical market in the world, providing significant opportunities for drug development and marketing.
Expert Profile:
Hans van Bronswijk, M.D., Ph.D.
Hans van Bronswijk, M.D., Ph.D.: Vice President, European Drug Development Practice, PAREXEL Consulting
Dr. Van Bronswijk is an internationally recognized drug development authority, with a unique combination of global regulatory, medical, scientific, and pharmaceutical industry experience.
He began his career as a medical doctor, working for 16 years as an internist and nephrologist at several major hospitals in the Netherlands. Dr. Van Bronswijk then spent nine years with the Dutch Medicines Evaluation Board (MEB), including three years as the head of the department of clinical assessment. He also served two, three-year terms as the official Dutch representative on the EU’s Committee for Medicinal Products for Human Use (CHMP). Following his time with MEB, Dr. Van Bronswijk joined Nefarma, the trade organization representing the Dutch pharmaceutical industry, where he promoted medicinal product research in the Netherlands. Immediately prior to joining PAREXEL Consulting in 2007, Dr. Van Bronswijk was Global Head of Regulatory Affairs for the transplantation and immunology business unit of Novartis Pharma AG.
With his broad regulatory and scientific background, Dr. Van Bronswijk advises PAREXEL clients on all aspects of clinical drug development and regulatory affairs, helping them navigate the increasingly complex requirements for bringing new products to market. His areas of expertise include the development of effective clinical trial plans for global markets, European registration procedures, and strategies for maximizing interactions with the European Medicines Agency (EMEA) and national regulatory bodies. He also provides specific therapeutic-area knowledge in the clinical development and registration of therapies for kidney diseases and transplantation. Dr. Van Bronswijk is based at PAREXEL’s office in Uxbridge, UK.
“In today’s regulatory environment, companies often underestimate the difficulty of developing clinical plans that meet the safety, efficacy, and pharmacoeconomic requirements of regulatory agencies in Europe, North America and other global markets,” Dr. Van Bronswijk said. “I enjoy the challenge of working with different types of companies and applying my experience to help them prepare comprehensive development plans and robust regulatory strategies that will support the successful registration and marketing of their products.”
Dr. Van Bronswijk, a native of the Netherlands, received his medical degree from the University of Amsterdam Medical School, specializing in internal medicine and nephrology. His clinical experience includes renal replacement therapy, organ transplantation, microbiology and quality of life research. He also taught at the Free University Hospital in Amsterdam and the University Hospital Leiden in the Netherlands. He earned his Ph.D. at the Free University of Amsterdam.