Formerly, Assistant to the Director, International
Affairs Staff, Center for Devices and Radiological Health, U.S.
F.D.A.
Agency During Fellowship Food and Drug Administration
Home State Vermont
Professional Specialty
Captain (Retired), Public Health Service
Host Agencies in Japan Ministry of Health, Labour, and Welfare (MHLW) – Pharmaceutical and Medical Safety Bureau, Evaluation and Licensing Division (ELD) Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) The Organization for Pharmaceutical Safety and Research (OSPR)
Placement Description
September 2001 – September 2002
Learned about the Japanese designation of medical devices for rare diseases,
the administration of the orphan product grant program, and the review process
for medical devices prior to marketing.
Representative Activities:
· gave a presentation on the FDA’s orphan products designation and grant processes at a study meeting regarding orphan drugs and devices
· attended two public advisory council meetings on the issue of Bovine Spongiform Encephalopathy (BSE) and provided information regarding the FDA’s stance on medical devices containing bovine products
· attended a meeting to discuss pediatric drug trials as well as to begin discussions about electronic data collection and transfer, with members of ELD and pediatricians from the National Children’s Hospital
· attended Pediatric Clinical Trials Study Group meeting
· attended the International Conference of Rare Disorders and Orphan Drugs in Taipei
· met with Vice President of GE Japan and General Manager of GE Yokogawa Medical Systems to discuss numerous issues related to medical device review/approval in Japan
· traveled to the National Cardiovascular Hospital in Osaka to visit the hospital’s Clinical Trials Unit and to discuss its ongoing clinical trials
Post Fellowship
Current U.S. Government Assignments and Activities
Assigned as Assistant to the Director, International Affairs Staff at the Center for Devices and Radiological Health. Authored “U.S. Orphan Drug System,” chapter in Orphan Drug Handbook: General Guidelines About the Orphan Drug System, both in Japanese and English, published by Orphan Drug Institute in 2003.
Current Title
Associate Director for Policy
OUSD/Defense Language Office
Agency During Fellowship United States Navy
Home State Arizona
Professional Specialty
Commander, United States Navy
Host Agencies in Japan Japan Defense Agency (JDA) –
· Secretariat Division
· Defense Policy Bureau, Strategic Studies Office Diet Internship
Ministry of Foreign Affairs (MOFA) –
· Asian and Oceanian Affairs Bureau, Regional Policy Division
· Asian and Oceanian Affairs Bureau, China Division
Placement Description
September 2001 – September 2002
Examined how the Japan Defense Agency develops and implements security policy; gained an understanding of JDA's organizational structure; learned how Japan develops policies with China and Korea; and developed an in-depth understanding of JDA's perspective on the international security environment.
Representative Activities:
· visited Japan Ground Self Defense Force Camp Asaka and Japan Air Self Defense Force Base Iruma
· visit the National Defense Medical College, the Defense Academy and the National Institute for Defense Studies (NIDS)
· attended two briefings on the Revolution in Military Affairs (RMA), one on terrorism risk management and the other on Japan-China relations
· attended two-day ASEAN Regional Forum
· observed discussions in JDA about Japan’s peacekeeping operation, extent of Japanese activities, and the need to codify the operation into law/legislation, after the national Diet passed a new legislation to allow the Japan Self Defense Force to participate in Operation Enduring Freedom (OEF) in December 2001
· attended the first subcommittee meeting for the defense authorities in the Asia Pacific region
· visited Okinawa and Iwakuni to observe field operations of Japan Maritime Self Defense Force facilities
· during visit to Oita Prefecture, her host Diet member’s constituency, observed interaction between local staffers and the member’s constituents, and how the grassroots support network in the member’s district works
· attended Diet sessions
· attended an international conference on human trafficking held in Bangkok, Thailand in June 2002
Post Fellowship
Current U.S. Government Assignments and Activities
Assigned as Commanding Officer of Navy Recruiting District New York
Current Title
Senior Compliance Officer
Center for Drug Evaluation and Research
Office of Compliance, Division of Manufacturing and Product Quality
Food and Drug Administration
Department of Health and Human Services
Agency During Fellowship Food and Drug Administration
Home State New York
Professional Specialty Senior Compliance Officer
Host Agencies in Japan Ministry of Health, Labour and Welfare (MHLW) – Pharmaceutical and Medical Safety Bureau
· Compliance and Narcotics Division, Good Manufacturing Practice (GMP) Section
· Evaluation and Licensing Division Pharmaceutical and Medical Device Evaluation Center (PMDEC)
Diet Internship
Taiho Pharmaceuticals, Inc.
Placement Description
September 2001 – September 2002
Learned about the Japanese Good Manufacturing Practice guidelines and regulations for drugs; examined the Japanese drug inspection process; and gained an understanding of the relationships between the Japanese pharmaceutical industry, their trade organizations and the Japanese government.
Representative Activities:
· Reviewed and provided comments on the World Health Organization (WHO) Scheme for the Certification of Pharmaceutical Starting Materials Moving in International Commerce
· attended a one-day meeting with WHO representatives visiting Japan to gather preliminary information to assess the MHLW as a National Regulatory Authority (NRA)
· participated in a half-day session of the 38th National Medical/Drug Guidance Conference
· participated in a two-day meeting of Japan’s prefectural health departments and the MHLW
· participated in a three-day inspection in Iwate Prefecture
· participated in a three-day inspection in Chibe Prefecture
· made presentations on ICH-Q7A from the FDA perspective before pharmaceutical company staffers and regulators from prefectural inspectorates in Tokyo and Osaka
· observed interactions between Taiho Pharmaceuticals and the local prefectural MHLW officials
Post Fellowship
Current U.S. Government Assignments and Activities
Appointed as the FDA/CDER/Office of Compliance Liaison for the Exchange of
Letters Agreement between FDA and MHLW in June 2003. Returned to Tokyo in September 2003, to meet with MHLW to discuss the progress of the agreement and next steps for collaboration. The Japanese participants at this meeting were colleagues from one of the MHLW units where Monica was placed during her Fellowship year in Japan.
Current Title
Senior Loan Specialist
Department of Agriculture
Power Supply Division
Financial Analysis, Security & Compliance Branch
Agency During Fellowship
The Export-Import Bank of the United States
Home State Virginia
Professional Specialty
Financial Analysis, Security & Compliance
Host Agencies in Japan Japan Bank for International Cooperation (JBIC) – International Finance Department I, Division II Ministry of Economy, Trade and Industry (METI) – Trade Insurance Division Nippon Trade and Investment Insurance (NEXI) –
· Planning and Administration Department, General Management Division
· Independent Administrative Institution Underwriting Department I, Europe, Middle East and Africa Group
· Financial Risk Management Department, Country Risk Analysis Group
Placement Description
September 2001 – September 2002
Gained an understanding of the Japan Bank for International Cooperation's transactions and projects with Asian countries; learned how Japan analyzes short-, medium- and long-term export credit insurance transactions.
Representative Activities:
· evaluated equity investment funds in Asia through financial ratio analysis
· conducted quantitative and qualitative evaluation of a Philippine telecom company
· attended the Third JBIC Seminar for International Finance (JSIF-3)
· wrote an article for the JBIC newsletter
· worked with her colleagues to produce a country review report and provide the latest economic statistics and news
Post Fellowship
Current U.S. Government Assignments and Activities
Returned to the Export-Import Bank of the United States as Relationship Manager
Current Title
Program Manager, Natural Gas Star Program
Agency During Fellowship
U.S. Environmental Protection Agency
Home State Michigan
Professional Specialty Program Manager, Coalbed Methane Program
Host Agencies in Japan New Energy Development Organization (NEDO) Ministry of the Environment (MOE)
Diet internship
Placement Description
September 2001 – September 2002
Learned how the Japanese government identifies and implements greenhouse gas reduction policies and projects; gained an understanding of Japanese government policy positions and proposed structures for domestic and international greenhouse gas emissions trading; and explored how the Japanese government reaches consensus on greenhouse gas emissions trading policy.
Representative Activities:
· helped develop a two-week energy efficiency workshop from October 7 to 20, 2001. Served as an official NEDO workshop facilitator
· traveled to Kyoto to attend a greenhouse gas (GHG) reduction project grant selection meeting at the Research Institute of Innovative Technology for the Earth (RITE)
· initiated a brown-bag lunch speech series in the office
· traveled to Kushiro, Hokkaido, to visit Japan’s last coal mine – the Taiheiyo Coal Mine, which had been in operation since 1920 until its closure on January 31, 2002. Met with two officials at the mine and discussed the history of the various coal mine methane projects at Taiheiyo.
· visited the Aichi Steel Foundry in the central part of Japan. Met with officials of Aichi Steel Foundry and discussed the progress of a research project for energy efficient steel plant flue gas scrap metal dust recovery
· traveled with a Japanese colleague to Tsukuba, a Tokyo suburb, to visit several grantees of NEDO at the National Institute of Advanced Industrial Science and Technology
· met with two representatives from Mitsui Corporation, a major trading company, to discuss various techniques that Mitsui could use to reduce GHG emissions
· met with representatives of Natsource-Japan, a cutting-edge GHG project development and trading company to talk about various techniques that the company could employ to assure that its readings and data are acceptable from the standpoint of world GHG accounting procedures.
· participated in preparations for the World Summit on Sustainable Development (WSSD) in Johannesburg, South Africa
· helped staff draft reports and policy papers for the Asia-Pacific Forum for Environmental Development (APFED). Attended the APFED meeting in Jakarta, Indonesia in May 2002.
Post Fellowship
Current U.S. Government Assignments and Activities
Returned to the Environmental Protection Agency as Program Manager
Current Title
Supervisory Special Agent, Cyber Task Force Unit, FBI Headquarters
Agency During Fellowship
Federal Bureau of Investigation
Home State
Hawaii
Professional Specialty Special Agent, Computer Crimes Squad
Host Agencies in Japan National Police Agency (NPA) –
· Communications Bureau, High-Tech Crime Technology Division
· Community Safety Bureau, Community Safety Planning Division/Juvenile Division/Consumer and Environment Protection Division Cabinet Secretariat Branch for IT Security Tokyo Metropolitan Police Department – High-Technology Crimes Control Center Osaka Prefectural Police Headquarters – International Criminal Investigation Division
Placement Description
September 2001 – September 2002
Learned how the National Police Agency manages its cyber crimes program; learned how other departments and organizations, within the government of Japan and the private sector, deal with cyber crimes and their coordination with the NPA
Representative Activities:
· visited the National Research Institute of Police Science, Fingerprint Identification Center, National Police Academy, and the Police Communications Research Center
· met with a law professor at Keio University who is an expert on law enforcement in Japan
· attended a meeting between the NPA and Zeus Card Service, a major Japanese credit card company that handles international transactions
· attended a meeting between the Tokyo Metropolitan Police Department and the NPA
· developed agenda and identified speakers for an IT security seminar, held in March 2002: “U.S. Cyber Security Evolution Since 9-11”
· participated in the preparation of the Japanese delegation for the March 2002 Center for Strategic and International Studies (CSIS)-Singapore Conference on cyber-terrorism
· participated in the computer forensic analysis of seized computers involving child pornography and investment fraud
· wrote two articles for the Tokyo Metropolitan Police Department’s monthly journal, Jikei (vigilance), and another article for publication in the National Police University journal
· participated in various investigative activities, including the searches of a residence and a business fronting as a brothel
· observed the procedures involved in securing a search warrant
· visited Kansai International Airport and met officials from various law enforcement agencies, including customs, immigration and police
Post Fellowship
Current U.S. Government Assignments and Activities
Returned to the Federal Bureau of Investigation as Special Agent
Current Title
Supervisory Special Agent, Legal Instructor, FBI Academy
Agency During Fellowship
Federal Bureau of Investigation
Home State Utah
Professional Specialty
Special Agent, Legal Advisor, Violent Crime and Counter-terrorism Matters
Host Agencies in Japan National Police Agency (NPA) –
· International Affairs Division
· Drug Control Division
· Firearms Control Division
· Organized Crime Department, First Division/Second Division Diet Internship Tokyo Metropolitan Police Department
Placement Description
September 2001 – September 2002
Gained practical knowledge regarding how Japanese law enforcement entities address organized-crime and counter-terrorism; observed how organized-crime and counter-terrorism cases are initiated, investigated and prosecuted; explored opportunities to improve communication between the FBI and Japanese law enforcement entities.
Representative Activities:
· visited the Fingerprint Identification Center
· visited the National Research Institute of Police Science
· worked with his colleagues to plan and coordinate the Third Seminar on Control of Drug Offenses, a three-week international conference co-sponsored by the NPA and the Japan International Cooperation Agency (JICA, equivalent of USAID in Japan)
· visited the Firearms Control Sections of the Toyama and Niigata Prefectural Police Headquarters to observe how the members of NPA interact with officers at Prefectural Police Departments
· made a presentation that compared how the FBI and Japan conduct organized crime investigations at NPA
· attended Diet sessions
· attended a meeting between Prime Minister Junichiro Koizumi and a select group of Diet Members
Post Fellowship
Current U.S. Government Assignments and Activities
Returned to the Federal Bureau of Investigation as Supervisory Special Agent and Legal Advisor
Current Title
Attorney-Advisor
Office of General Counsel
National Oceanic and Atmospheric Administration
U.S. Department of Commerce
Agency During Fellowship
National Oceanic and Atmospheric Administration
Home State Maryland
Professional Specialty Attorney
Host Agencies in Japan Fisheries Agency of Japan – Resources Management Department, Resources Management Division, Total Allowable Catch (TAC) Section Diet Internship Hokkaido Department of Fisheries and Forestry – Marine Resources Management Division
Placement Description September 2001 – September 2002
Gained an understanding of Japanese fishery management laws, policies, processes and issues by working with Japanese officials responsible for the sustainable use of fishery resources within Japan's exclusive economic zone; developed a practical working knowledge of the policy and legal aspects of fishery management in Japan.
Representative Activities:
· made a presentation in Japanese on U.S. fisheries management at the National Resource Management Promotion Conference in Sapporo
· attended TAC Subcommittee of the Resource Management Subcommittee where the 2002 TACs were approved
· attended the Liberal Democratic Party (LDP) Committee on Agriculture, Forestry and Fisheries
· had a 13-day business trip to Fukuoka. Met with the Regional Director of the Kyushu Fisheries Coordination Office. Visited Fukuoka Fisheries and Marine Technology Research Center. Spent 10 days of the 13-day trip on the Hakuryu Maru, a Japanese fishery patrol boat in the region.
· served as a member of the Japanese delegation to the intercessional meeting of the International Commission for the Conservation of Atlantic Tuna, held in Tokyo
· observed Diet sessions
· participated in an LDP study meeting on the northern territories
· visited research laboratories, fisheries cooperatives, fish processing plants, aquaculture facilities, and other fisheries-related facilities in Hokkaido
Post Fellowship Current U.S. Government Assignments and Activities
Returned to the National Oceanic and Atmospheric Administration as Attorney-Advisor
Monica E. Caphart
Marina L. Chu 
Roger L. Fernandez 
Inez M. Miyamoto 
Jonathan L. Rudd
Constance J. Sathre