Hans van Bronswijk, M.D., Ph.D.
VP, 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.
Coming Up
Tara Ferguson, PAREXEL's Director of Pharmacovigilance Operations, is a featured speaker at the Pharmaceutical Information & Pharmacovigilance Association conference July 8 in the UK.
Regulatory Challenges
in the Asia-Pacific Region
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.
The process for developing and introducing new biopharmaceutical products for the Japanese market has evolved significantly over the past decade. In the past, Japanese regulators required that clinical trials be conducted in Japan for any potential new pharmaceutical product to be approved for sale in that country – even if successful trials and regulatory approvals had already taken place in other parts of the world. As a result of these policies and the high cost of conducting trials in Japan, many novel therapies are unavailable to Japanese patients, or become available long after they reach the market in other regions.
Asian countries continue to be increasingly important locations for today's clinical trials. In a recent study of clinical investigators signing on to conduct new clinical trials in 2007, PAREXEL found a wealth of intriguing information.