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Speakers' Profile

East Asian Pharmaceutical Regulatory Symposium 2008

Speakers' Profile

Dr. Tatsuya Kondo, Chief Executive, PMDA (Japan)
Opening Remarks
 
Dr. Tatsuya Kondo is currently the Chief Executive of Pharmaceuticals and Medical Devices Agency (PMDA).
He has a lot of clinical experiences as a neurosurgeon since he graduated from Medical Department of the University of Tokyo in 1968. He worked for the department of neurosurgery in the 1st national hospital (1972 ~ 1974) and the department of Neurosurgery, Faculty of Medicine, The University of Tokyo (1974 ~ 1978).
He studied the biology of brain tumor as a visiting researcher with Max-Planck scholarship at Max-Planck Institute, West Germany from March to December of 1977.
He served as a neurosurgeon at International Medical Center of Japan from 1978 to 2003 and he contributed to hospital management and clinical discipline as the Director of the hospital, International Medical Center of Japan from April, 2003 to March, 2008.
Dr. Young-Chan, Kim, Director General, Pharmaceuticals Headquarters, KFDA (Korea)
Global Development: Korea's perspective and the Role of KFDA

 
Academic Background
  • B.S.(1977) College of Pharmacy, Chosun University
  • M.S.(1992) College of Industrial science, Sungkyunkwan University (major : Public health)
  • Ph.D(1997) College of pharmacy, Dongduck women's University (major:Biochemistry)

Major Experiences
  • 1981 ~ 1993.8: Assistant director Pharmaceutical policy bureau of Ministry of Health and Social Affairs
  • 1993.9 ~ 1999.12: Deputy director Pharmaceutical policy bureau of Ministry of Health and Welfare, pharmaceutical safety team of KFDA
  • 2000.1 ~ 2006.5: Director Biopharmaceutical safety team, Pharmaceutical safety policy team of KFDA
  • 2003.12 ~ 2006.6: Educational Training Utah University of Pharmacy
  • 2006.6 ~ 2007.6: Director General Gwang-ju Resional Food and Drug Administration
  • 2007.6 ~ present: Director General Pharmaceutical Headquarters, KFDA
Dr. Tatsuo Kurokawa, Councilor, Minister's Secretariat, MHLW (Japan)
Global Development: Japan's perspective and the Role of MHLW
 
Dr. Kurokawa was graduated from the Faculty of Pharmaceutical Sciences, Chiba University. Immediately after graduation, he joined the Ministry of Health and Welfare Japan (MHW). There he gained experience in GMP and in drug inspections, and soon transferred to the Safety Division of the Pharmaceutical Affairs Bureau, MHW. He is a Pharmacist.
For about two years, Dr. Kurokawa worked for the World Health Organization at their headquarters in Geneva, Switzerland, and at their Western Pacific Regional Office, in Manila, Philippines, as a junior professional officer in pharmaceuticals. On his return to Japan, he transferred to the Science and Technology Agency. In 1984, Dr. Kurokawa again joined the MHW as a specialized officer for international collaboration. On several occasions, he served as a member of the Japanese Delegation to the World Health Assembly.
In 1989, Dr. Kurokawa joined the New Drug Division of MHW, responsible for new drug evaluation and registration. He also participated in ICH activities as Japan's ICH coordinator, then as the Japanese representative to the ICH Steering Committee. His service continued from the very first preparation meeting for ICH in 1990 to ICH-3, in Yokohama, in 1996. In 1995, he gained his doctoral degree for his study of the international comparison of new drug development and evaluation.
Throughout his career, Dr. Kurokawa has concerned himself with drug safety. He was head of Office for Promotion and Appropriate Use of Drugs from 1994 to 1996; there he was responsible for pharmacovigilance. He also served as Director of the Safety Division of MHLW from 2000 to 2003, and then worked at the Organization for Pharmaceutical Safety and Research (currently Pharmaceuticals and Medical Devices Agency) as Councilor.
In August 2004, Dr. Kurokawa was appointed to the Councilor for Pharmaceuticals and Food Safety, Minister's Secretariat, Ministry of Health, Labour and Welfare, Japan.
Dr. In-Kyu, Kim, Director, Chemistry & Cardiovascular Team, KFDA (Korea)
Session 1 Current Status and Future Direction of GMP
Latest Trend of Drug Quality / GMP in Korea
 

Education:
  1. Mar. 1978 ~ Feb.1982: College of Pharmacy, KyungHee University, Seoul Korea (Bachelor)
  2. Mar. 1983 ~ Aug. 1985: College of Pharmacy, KyungHee University (M.S.)
    "Studies on Preparation and Dissolution of Mefenamic acid Microcapsules by Gelatin-Acacia Coacervation."
  3. Sep. 1988 ~ Feb. 1994: College of Pharmacy, Kyunghee University (Ph. D.)
    "Preparation and Evaluation of Controlled Release Delivery System for Phenylpropanolamine HCl using Resin Complex"

Occupation:
  1. Served as junior and senior researcher at Department of Drugs in Korea National Institute of Health (KNIH) (June 1982 to Feb. 1996)
  2. Served as senior researcher at Department of Drugs Evaluation in Korea Food and Drug Administration (KFDA) (Feb. 1996 to June 2000)
  3. Served as division director at Department of Medical Devices and Radiation Health in Korea Food and Drug Administration (KFDA) (June 2000 to July 2002)
  4. Served as director at Team of Antibiotics and Oncology Products, Department of Drug Evaluation, Korea Food and Drug Administration (KFDA) (Aug 2004 to Sept.2007)
  5. Served as director at Chemistry and Cardiovascular Team, Department of Drug Evaluation, Korea Food and Drug Administration (KFDA) (Sept.2007 to Present)

Training:
  1. Post Doctoral fellow at College of Pharmacy, University of Utah, Aug. 2002 to July 2004
    on Controlled release of polypeptide (calcitonin salmon) with thermosensitive polymer
  2. Visiting Scientist to US FDACenter for Drug Evaluation and Research (CDER) in Washington D.C.
    on "The study of the effect of drug- excipients interaction on in vitro drug release into an aqueous system" from Oct. 1 1994 to Mar. 30 1995
  3. Training program on the utilization of medicinal and aromatic plants in the pharmaceutical and related industries sponsored by UNIDO at Eskisehir University in Turkey, 7th-26th September 1992
Mr. Shingou Sakurai, Director for GMP Inspection, Office of Compliance and Standards, PMDA (Japan)
Session 1 Current Status and Future Direction of GMP
Latest Trend of Drug Quality / GMP in Japan
 
Dr. Shingou Sakurai is a Director for GMP Inspection, Office of Compliance and Standard, PMDA, Tokyo. After graduated from the master course in Pharmaceutical Science of Tokyo Science University, he first joined a company in 1985, and experienced a researcher, technical staff, quality control manager of pharmaceuticals and manufacturing manager of biotechnological products. During his industry carrier, he had a chance to study quality control of vaccine at National Institute of Infectious Disease in two years, and granted a Ph. D in Health Science from Tokyo University. After nineteen years of industry experience, he joined PMDA in 2004 as a Principal inspector of the Office of Compliance and Standards.
Dr. Joon-Su, Shin, Deputy Director, Pharmaceutical Management Team, KFDA (Korea)
Session 2 Post-Marketing Safety Measures
Post-Marketing Safety Measures in Korea
 

Education
  • 1994.3-1999.8: Doctor degree(Pharmacy) Seoul National University(SNU)

Experiences
  • 1999.2-2002.2: Researcher(Post-doc), Research Institute of Pharmaceutical Sciences, SNU
  • 2002.2-2004.2: Responsible Researcher, Dong-Wha Pharmaceuticals (Research Institute)
  • 2004.2-2005.11: Team Leader, Dong-Wha Pharmaceuticals(Clinical Research Team)
  • 2005.11- : Deputy Director, Korea Food & Drug Administration
Mr. Akira Kawahara, Chief Safety Officer, PMDA (Japan)
Session 2 Post-Marketing Safety Measures
Post-Marketing Safety Measures in Japan
 
Mr. Akira Kawahara is Chief Safety Officer of PMDA, Tokyo. He first joined the Ministry of Health, Labor and Welfare in 1977, after that he served mainly in Pharmaceutical and Medical Devices area in the Ministry,
In his previous posts, he served as Director of Evaluation and Licensing Division, Pharmaceutical and Food safety Bureau and Pharmaceutical Management Director in Medical Economics Division, Health Insurance Bureau of the Ministry headquarter.
Mr. Kawahara graduated from Faculty of Pharmaceutical Sciences, Kyushu University,Fukuoka and he earned a Masters in Pharmaceutical Sciences.
Mr. Hidetoshi Shuto, Corporate Officer / Vice President, Clinical Development I, Development Astellas Pharma Inc. (Japan)
Global Clinical Trial and Development / Industry's View
Global Clinical Trial and Development: JPMA's Perspective
 

Education and Specialized Field
  • 1974-1980 : Department of Health Chemistry, Faculty of Pharmaceutical Science, Kyoto University, Kyoto, Japan
  • Master of Science in Pharmacy, Mar. 1980
  • Bachelor of Science in Pharmacy, Mar. 1978

Professional Experience
  • 1980-Present : Astellas Pharma Inc.( Fujisawa Pharmaceutical Co.,Ltd. previously)
  • 2007-Present : Corporate Officer, Vice President, Clinical Development I, Astellas Pharma Inc.
  • 2006-2007 : Vice President, Clinical Development I, Astellas Pharma Inc.
  • 2002-2006 : Senior Director, Drug Development Project Management, Fujisawa Healthcare Inc.( followed by Astellas Pharm US)
  • 1995-2002 : Associate Director, Clinical Research, Fujisawa Pharmaceutical Co., Ltd.
  • 1985-1995 : Manager, Research Planning, R&D, Fujisawa Pharmaceutical Co., Ltd.
  • 1980-1985 : Planning & Coordination, R&D, Fujisawa Pharmaceutical Co., Ltd.
Dr. Timothy R. Franson, Vice President for Global Regulatory Affairs Operational Committee Member, Eli Lilly (USA)
Global Clinical Trial and Development / Industry's View
Global Clinical Trial and Development: PhRMA's Perspective
 
Timothy R. Franson, M.D., is currently Vice President of Global Regulatory Affairs for Lilly Research Laboratories and is also an Assistant Professor of Medicine at Indiana University School of Medicine. He received his undergraduate degree in Pharmacy (B.S. Pharm, honors) at Drake University, his M.D. degree (James Scholar, with honors) at the University of Illinois, and completed internal medicine training at the University of Iowa, followed by a fellowship in Infectious Diseases and Epidemiology at the Medical College of Wisconsin. He is Board Certified in Internal Medicine and Infectious Diseases. He was Assistant Professor of Medicine and Hospital Epidemiologist at the Medical College of Wisconsin where he was a NIH funded investigator and a member of the State of Wisconsin's Governors Task Force on AIDS. He joined Eli Lilly and Company in 1986, where he has previously served as Director of Anti-Infectives; Group Medical Director, Europe (based in the United Kingdom); Executive Director of Health Economics Research and Decision Sciences, Executive Director of Regulatory Affairs responsible for North American Regulatory, Chemistry Manufacturing Control, Planning & Global Operations (safety, labeling, medical information, registration and submissions) and from 1997-2003, Vice President of Clinical Research and Regulatory Affairs-US. In 2002, he received the Lilly Chairman's Ovation Award.
Dr. Tsutae Den Nagata, Director General, EFPIA Japan / Statutory Auditor, Medical Advisor, GlaxoSmithKline K.K. (Japan)
Global Clinical Trial and Development / Industry's View
Global Clinical Trial and Development: EFPIA's Perspective
 
Tsutae "Den" Nagata, MD, PhD, FFPM

EDUCATION:
Tokyo Medical and Dental University Graduate School, Tokyo; PhD, 1982; Tokyo Medical and Dental University, Tokyo; MD, 1978; Amherst College, Amherst, MA; BA, 1970 (Religion, Pre-Medicine); Tokyo University Faculty of Law, Tokyo; BA, 1967 (Political Science)

PROFESSIONAL POSITIONS:
European Federation of Pharmaceutical Industries and Associations in Japan (EFPIA Japan): Director General, March 2007-present; Kagurazaka D.S. My Clinic, 2003-present; GlaxoSmithKline (Japan): Director, Development & Medical Affairs, 2001-February 2007; Board Member, 2001-January 2008; Statutory Auditor; February 2008-present; SmithKline Beecham Seiyaku: Director, Post Registration Medical Affairs, 1992; Director, Research & Development, 1995-2001; Board Member, 1993-2001; Bristol-Myers Squibb: Medical Director, 1989-1992; Director of Research Operations, 1991-1992; Tokyo Metropolitan Police Hospital: Departments of Surgery and Urology, 1978-1989; Department of Surgery, 1989-1999

AFFILIATIONS:
Japanese Association of Pharmaceutical Medicine; Faculty of Pharmaceutical Medicine, Royal College of Physicians, The University of London; Japanese Urological Association; Japan Surgical Society

HONORS & AWARDS:
Fellow of the Faculty of Pharmaceutical Medicine, Royal College of Physicians, The University of London ; Kanzo Uchimura Memorial Scholarship; 1967-1970, Amherst College; Fulbright Travel Grant; 1967-1970
Dr. Christina LIM, Health Products Regulation Group, Senior Advisor, International Collaboration, HSA (Singapore)
Global Clinical Trial and Development / Regulator's View I
Review Policies for Global Drug Development: Singapore's Perspective
 
Christina joined HSA in Jan 2007. She is Administrator of the Health Product Regulatory Group (HPRG) at the Health Sciences Authority (HSA), and also Senior Advisor for International Collaboration. As Administrator of HPRG, she is responsible for leading and managing the Group which involves clinical trials, premarket authorization, postmarket vigilance, manufacturing and quality assurance, inspection, enforcement and prosecution of all health products and medical devices. She also advises on international collaboration activities in HSA.
Prior to HSA, she was Senior Vice President of theVertex Group in the Singapore Technologies. She was with the Group for over 15 years in venture fund management investing in technology-based companies and biotechnology companies worldwide.
Early in her career, Christina was with the Ministry of Foreign Affairs where among other duties she was Commercial Secretary in the Singapore Embassy in France, and Senior Assistant Director in charge of Vietnam, Laos, Cambodia, and Thailand.
She graduated with a Bachelor of Pharmacy degree from the University of Singapore (Chalmers medalist), and continued with her Ph.D. (Honors List) in Pharmacodynamics from the University of Montpellier in France under a French Government scholarship from 1968-1971. She is fluent in both English and French, and conversant in Mandarin.
Dr. Yuppadee Javroongrit, Assistant Director & Head of International Affairs & IND Section, Food and Drug Administration, Thai FDA (Thailand)
Global Clinical Trial and Development / Regulator's View I
Review Policies for Global Drug Development: Thailand's Perspective
 
Dr. Yuppadee Javroongrit obtained her B.Sc. in Pharmacy in Thialand, and M.S.&Ph.D. in Industrial Pharmacy at Massachusetts College of Pharmacy and Health Sciences(MCPHS) in the USA.
She started to work in the Food and Drug Administration of Thailand (ThaiFDA) at Inspection Division, and then the Drug Control Division. During those times, she had experienced working on GMP Inspection, strengthening Drug System Policies regarding Quality Assurance on Active Pharmaceutical Ingredient (API), Combating a Counterfeit Drug. Her current works are on the Clinical Trial's Regulation and Global harmonization & evolution of the ThaiFDA.
She has been assigned to take a full responsibility on Pharmaceutical Harmonization of the office towards the ASEAN, as a Co-Chair of ACCSQ/PPWG, since 1999. At the Office, she is the Head of "International Affairs and Investigational Drug Group", and Assistant Director of Drug Control Division, ThaiFDA.
Since 2000, she has actively participated, as invited Speaker/Chair-Co chair session/ Member, in various Regional and Global forums; i.e. ACCSQ, APEC-LSIF, ICH-GCG, the IFPMA-Asian Regulatory Conference, as well as the Symposium of APEC Network on Pharmaceutical Regulatory Science(in Korea, Japan(2006), and Taiwan(2007). In addition, she has also participated the presented in National Seminar, and the specific Meetings, on Clinical Trials of Thailand.
Mr. In-Beom, Kim, Deputy Director, Pharmaceutical Safety Policy Team, KFDA (Korea)
Global Clinical Trial and Development / Regulator's View II
Review Policies for Global Drug Development: Korea's Perspective
 

Education
  • Mar. 1981 ~ April 1994 : College of pharmacy, Choongang Univ.
  • Mar. 1994 ~ April 1996 : Graduate School of Food and Drug Administration

Experiences
  • Jul. 1991 ~ April 1994 : Pharmaceutical Safety Division, Bureau of Pharmaceutical Affairs, MOHSA
  • April 1994 ~ April 1996 : Health-Related Industry Division, Bureau of Technical Cooperation, MOHW
  • April 1996 ~ Mar. 1998 : Pharmaceutical Development Division, Bureau of Pharmaceutical Affairs, MOHW
  • Mar. 1998 ~ Feb. 2005 : Pharmaceutical Safety Division / Pharmaceutical Management Division / Narcotics Control Division, Bureau of Pharmaceutical Safety, KFDA/Pharmaceutical Team, Daegu Regional KFDA
  • Feb. 2005 ~ April 2007: Pharmaceutical Policy Team, Office for Health and Medical Care Policy, MOHW
  • May 2007 ~ present : Pharmaceutical Safety Policy Team, Pharmaceutical Headquarters, KFDA
Mr. Kazuhiko Mori, Associate Center Director, PMDA (Japan)
Global Clinical Trial and Development / Regulator's View II
Review Policies for Global Drug Development: Japan's Perspective
 
Mr. Kazuhiko Mori graduated from Tokyo University, faculty of Pharmacy, after he finished the graduate school master's course and joined the pharmaceutical affaires bureau, the Ministry of Health and Welfare (MHW) in 1983. He started his carrier as a technical official taking charge of the New Drug Applications (NDA) review.
Mr. Mori is currently the Associate Director of Center for Product Evaluation in Pharmaceuticals and Medical devices Agency (PMDA). He is responsible for the coordination of the review and evaluation of NDA, clinical consultation for pharmaceutical industry covering all therapeutic area.
Dr. Satoshi Toyoshima, Executive Director, PMDA (Japan)
Global Clinical Trial and Development / Regulator's View II
Summary Report
 
Dr. Satoshi Toyoshima is currently Executive Director, Director of Center for Product Evaluation at the Pharmaceuticals and Medical Devices Agency (PMDA). He is responsible for the review and evaluation of NDA, Biologics, OTC/Generic Drugs, Medical Devices and Conformity Audit.
He received his Ph.D. from University of Tokyo in 1975. His Specialized Field was Biochemistry, Immunology, and Regulatory Science.
His career includes a post doctoral fellow at the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), USA (1977-1979), an Associate Professor at University of Tokyo, Faculty of Pharmaceutical Sciences (Xenobiotics Immunochemistry) (1980-1992), Deputy Director-General of Pharmaceutical Basic Institute of Japan Tobacco Co. Ltd. (1992-1995), and a Professor at Hoshi University (Biochemistry) (1995-2000), before joining Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), the predecessor of PMDA, as the Center Director in 2000.
Mr. Toshiro Nakagaki, Director, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW (Japan)
Global Clinical Trial and Development / Regulator's View II
Closing Remarks
 
Mr. Toshiro Nakagaki is currently the Director of the Evaluation and Licensing Division, Pharmaceutical and Food safety Bureau in the Ministry of Health, Labour and Welfare. After graduating from the school of Pharmaceutical Sciences at the University of Tokyo in 1979, he has held various positions in the Ministry of Health and Welfare, which is currently the Ministry of Health, Labour and Welfare. He has also worked as the first secretary in the Embassy of Japan in Indonesia.