2012國際醫療器材臨床試驗法規研討會

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講者介紹：

Ms. Jennifer KerrJennifer L. Kerr, MS, graduated fromPurdueUniversityin 1993 with a bachelor's degree in Engineering with an emphasis in Biomedical Engineering and in 1995 with a master's degree in Physiology. Since 1995 she has been involved in the oversight and management of clinical studies, first as a clinical monitor and currently as Vice President of Global Clinical Affairs at MED Institute, a Cook Group company (www.cookmedical.com).During this period, Jennifer has been involved in hundreds of global clinical studies for devices, drugs and biologics involving thousands of patients, hundreds of physicians and hospitals for the evaluation of the technologies for safety and performance. During the past several years, Jennifer has joined other global leaders and experts on Good Clinical Practice (GCP) in revising the international standard ISO 14155 for clinical device research. This specially selected committee of industry and regulatory authorities representing theU.S., Europe andJapanhave worked closely to ensure the revisions to the standard reflect real-world practice and can be adopted as the international standard for the conduct of device clinical studies. In addition, Jennifer is working with experts from the United States FDA, Japan MHLW, Japan PMDA and industry representatives as an active participant in the Harmonization by Doing (HBD) initiative through Working Group 4.Jennifer is a Certified Clinical Research Associate (CCRA) from the Association of Clinical Research Professionals (ACRP) as well as Regulatory Affairs Certified (RAC) from the Regulatory Affairs Professionals Society (RAPS).

Ms. Danielle GiroudWith more than 20 years of experience, Danielle Giroud is founder and senior faculty board member of the World Medical Device Organization (WMDO), an independent professional organization dedicated to serving the professional development and educational needs of medical device professionals from around the world. Giroud is a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multinational corporations and start-up companies around the globe. Currently, she also is the convener for ISO 14155 expert group TC 194 WG 4 on clinical investigations of medical devices in humans and a liaison with the EU Commission's Clinical Investigation and Evaluation (CIE) task force.

Ms. Shelley TangMs Tang retired fromAustralia's Therapeutic Goods Administration in July 2011.During her time at the TGA, she spent 11 years with the Microbiology Section of TGA Laboratories, specialising in assessment of sterile manufacture of medicines and devices, one year as head of the Biomaterials and Engineering Section of TGA Laboratories, managing the program of testing of medical devices and supervising the Medical Device Incident Reporting and Investigation Scheme, and ten years as Head of the Medical Device Assessment Section, responsible for the program of conformity assessment for medical devices, including assessment done under Australia's Mutual Recognition Agreement with Europe and the Memorandum of Understanding with Canada. She also led the development of the technical requirements forAustralia's new IVD regulatory scheme, introduced on 1 July 2010. At the time of leaving TGA, she held the position of Head of the Office of Devices Authorisation.Ms Tang holds a Bachelor of Applied Science, in Medical Technology, majoring in microbiology and histopathology. Prior to her retirement, she was Chair of the Global Harmonisation Task Force Study Group 1 sub-group on IVDs, and a member of the International Standards Organisation Technical Committee 212, developing standards for IVDs.She currently runs her own company, Stellar Consulting, providing consulting services both nationally and internationally on the regulation of medical devices, including IVDs, and working with WHO to develop regulatory systems for IVDs in their target countries.

Dr. Madoka MurakamiDr. Madoka Murakami is a Unit Chief of Division of Regulatory Cooperation in the Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA),JAPANsince April 2012. Currently, she is tasked with international harmonization activities such as the Global Harmonization Task Force (GHTF) and the Harmonization By Doing (HBD).She graduated fromKeioUniversityin 2003, and then received her master's degree and doctoral degree fromTokyoMedicalDentalUniversityin 2005 and 2011. She joined PMDA in 2005 and worked as a reviewer of Office of Medical Device till March 2012.