China has long been considered a potential clinical trials mecca due to its massive patient population, cost-effective investigator sites and an expanding presence of qualified contract research organizations. However, regulatory hurdles, logistical complexities and governmental instability has historically discouraged much focus on China from the pharmaceutical and biotech sectors.
Times have changed! Currently an unprecedented number of new studies are being planned and conducted in China. Nevertheless, many challenges still exist and must be overcome in order to ensure clinical trial investments are not negated by regulatory burdens.
This webinar will provide an overview of:
The clinical trial approval process in China Import procedures for investigational drugs Unique logistical and cold chain challenges
Our knowledgeable speakers have years of regulatory and logistical experience in emerging countries, including China.
Speakers
Frank Reale Associate Director
Worldwide Regulatory Coordination & Clinical Supplies Merck Research Laboratories
Frank has been employed by Merck Research Laboratories in Rahway, New Jersey for the past 18 years. He is responsible for all internal and external regulations governing clinical trial materials used for worldwide human clinical trials and drugs provided to competitors or other external sources. He is an integral member of project teams providing guidance and direction on regulatory clinical trial material aspects as well as contributing to the overall regulatory strategy of multiple projects. In addition, he provides regulatory guidance to Pharmaceutical Research & Development on issues regarding packaging, labeling, importation, exportation and sourcing of clinical trial material. He is also responsible for the timely assembly and submission of registration or re-registration documents worldwide. This includes the coordination of IND’s/CSA’s, NDA/WMA’s, and PLA’s. He is liaison with worldwide subsidiary personnel in over 95 countries. Frank received his degree in Pharmacy from Brooklyn College of Pharmacy and has also completed an approved Clinical Pharmacy residency.
Mike Sweeney Global Director of Strategic Development World Courier, Inc.
Mike has created logistical solutions for World Courier’s pharmaceutical and biotech customer base since joining the company in 1992. Following several years of international customer service assignments, his focus shifted to global regulatory and operational development. Currently, he is responsible for continual improvements to his company’s clinical materials transport and depot storage services, including cold chain management processes as well as import and export. Mike also serves as his company’s chief biological transport expert, and he works closely with corporate quality assurance, operations and information technology on various future enhancement projects. He has spoken at various biopharmaceutical conferences, transportation seminars, training courses and clinical study investigator meetings around the world. Mike is a Member of ISPE, DIA and an advisor to the World Health Organization, and he currently serves on ISPE’s Investigational Products Community of Practice.
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The clinical trial approval process in China