Best Practices For Conducting Multinational Clinical Trials

Authors » Barb Geiger, BSN, RN Chris Wang Executive Vice President, Oncology and Latin America, Clinipace Worldwide Managing Director, Asian Operations, Clinipace Worldwide Barb Geiger has been in the clinical research and development industry Chris Wang serves as Managing Director, Asian Operations, following the for over 25 years. She is an executive clinical operations professional company’s recent acquisition of Choice Pharma. Chris is responsible for with extensive experience in oncology and CNS drug development. managing the day-to-day operating responsibilities for Clinipace’s Asian entities. Chris previously served as Associate Director, North East Asia at Choice Pharma. She is based out of Clinipace’s Taipei, Taiwan office. References » 1. IMS Institute for Healthcare Informatics. The global use of medicines: outlook through 2017. November, 2013. Accessed at http://www.imshealth.com/cds/imshealth/Global/Content/Corporate/ IMS%20Health%20Institute/Reports/Global_Use_of_Meds_Outlook_2017/IIHI_Global_Use_of_ Meds_Report_2013.pdf 2. Toller C. Clinical studies in Asia-Pacific: a regional perspective. Journal for Clinical Studies 5:223. 3. Bhuller R, Koul N. The rising dominance of the Asian CRO market. Frost and Sullivan. 2010. Accessed at http://www.slideshare.net/FrostandSullivan/frost-sullivan-the-rising-dominance-ofthe-asian-cro-market 4. Korieth K, Anderson A. New growth and decline in Asia clinical trials. The CenterWatch Monthly, 2013;20:1-6. 5. Price Waterhouse Coopers. The changing dynamics of pharma outsourcing in Asia: are you readjusting your sights? 2008. Accessed at http://www.pwc.be/en/pharma/The-changingdynamics-of-pharma-outsourcing-in-Asia.pdf 6. Patent Law of the People’s Republic of China January 25, 2011. Accessed at http://www. chinaipr.gov.cn/lawsarticle/laws/lawsar/patent/201101/1186462_1.html 7. Ministry of Economic Affairs, Taiwan. Patent Act 2014. Accessed at http://www.tipo.gov.tw/ct.a sp?xItem=479550&ctNode=6817&mp=2 8. Pharmaceutical Product Development, LLC. Optimizing drug registration in China: Category 1 route: whitepaper. April 2013. Accessed at http://www.ppdi.com/drug-registration-china/China_ CategoryI-Registration-PPD_White%20Paper.pdf 9. ASEAN sectoral mutual recognition arrangement for good manufacturing practice (GMP) inspection of manufacturers of medicinal products. April, 2009. Accessed at http://www.asean. org/archive/documents/Agreement%20on%20MRA%20for%20GMP%20Pharmaceutical.pdf 10. Health Sciences Authority, Singapore. Guideline on Application for Clinical Trial Certificate. January 8, 2013. Accessed at http://www.hsa.gov.sg/publish/hsaportal/en/health_products_ regulation/clinical_trials/guidelines/ctc_application.html 11. Schulz G. Clinical trial in Asia: opportunities and challenges. 2012Accessed at http://www. zuelligpharma.com/news/clinical-trial-asia-opportunities-and-challenges 12. http://moj.gov.vn/vbpq/Lists/Vn bn php lut/View_Detail.aspx?ItemID=27484 (translated by Google translate) 13. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare

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