India s Med Tech Market Commercial & Regulatory Landscape Opportunities and Challenges. MassMedic. 9 March 2012
|
|
- Amos Wiggins
- 7 years ago
- Views:
Transcription
1 India s Med Tech Market Commercial & Regulatory Landscape Opportunities and Challenges MassMedic Richard Paddock Director, Med Tech Intl Trade Administration 9 March 2012
2 Contents Applicable Background on India s Economy Medical Technology Products Market Regulatory Framework Evolving Policy and Regulatory Landscape Bilateral National Government Dialogues 2
3 International Trade Administration Assist American firms facing foreign trade barriers Monitor other countries compliance with trade agreements (WTO and FTAs) Manufacturing and Services Division (MAS) engages with foreign governments to address industry-specific issues, conducts research and analysis. ITA s Office of Health and Consumer Goods 3
4 India - Commercial Environment Economic/Political Landscape in Brief Healthcare Products Market Profile Healthcare expenditure at 4.8 % of the GDP Government spend is 0.9 % (2010) 0.9 beds per 1000 people (global average is 3.3) Shortfall of 1.4 million doctor; 2.8 million nurses Governments and the private sector trying to address accessibility & affordability of healthcare Healthcare national and state issues 4
5 Market Size and Healthcare Expenditures Country Medical Device Market Total ($M) 2009 Medical Device Imports ($000) 2009 Medical Device Import Growth % 2009 Health Expenditures ($B) 2009 Health Exp Per Capital ($US) 2009 Health Exp as % GDP 2009 (World Av 10.4) Japan 21, ,532, , China 6, ,982, Australia 3, ,144, , S Korea 3, ,126, , India 1, ,545,
6 India s Evolving Regulatory Landscape for Medical Technology Products The Government of India is in the process of developing a regulatory regime for medical products Background - Legislation Actions and Prospects for Central Authority Current regulation of medical products D&C Act of 1940 and D&C Rules of In 2005, ten categories of products were notified for registration requirement and licensing - cardiac stents, drug eluting stents, catheters, intra ocular lenses, I. V. cannulae, bone cements, heart valves, scalp vein set, orthopedic implants, and internal prosthetic replacement Import license 6
7 Regulatory Framework Central and State Governments Ministry of Health and Family Welfare Provides technical advise on medical and public health Implements various health schemes and services Central Drugs Standard Control Organization Registration and/or import of drugs, devices, vaccine diagnostic products, blood products and other products Department of Biotechnology Develops policy, also promotes and funds research activities Engages in capacity building activities Department of Pharmaceuticals Pharmaceutical policy - including education and research Manufacturing of drugs by government companies 7
8 Regulatory Framework Central and State Governments National Pharmaceutical Pricing Authority Atomic Energy Regulatory Board Other Ministries Finance, Commerce, and Environment State Governments Manufacturing licensing for pharmaceuticals and devices Inspection of facilities and enforcement Promotion of biotech/medical parks and provides incentives 8
9 Responsibilities of Regulatory Bodies Central Government Laying down standards of drugs, cosmetics, diagnostics, and devices Market authorization of new drugs. Regulation of clinical research Grants import license Testing of drugs by Central Drugs Labs Guidance on technical matters Monitoring adverse drug reactions State Government Licensing and Enforcement Monitoring of manufacturing and sales establishments Warehousing Wholesale Distribution Retail sale Licensing of drug testing laboratories Monitoring of quality of Drugs & Cosmetics, manufactured by respective state units and those marketed in the state 9
10 Proposed Central Drug Administration CDA Pharmacovigilance Imports Regulatory Affairs and Enforcement Organizational Services New Drugs & Clinical Trials Biological & Biotechnology Products Training and Empowerment Quality Control Affairs Medical Devices and Diagnostics Legal and Consumers Affairs 10
11 Challenges for Med Tech Companies in India s Med Tech Market Overview Absence of single nondiscriminatory, comprehensive and efficient regulatory system. Guidance documents still relate to drugs and not devices Pricing policies - information requirements Labeling and Barcoding New requirements for clinical trials/evaluation New adverse event reporting structure is as per drugs Implementation of AERB guidelines for imaging equipment 11
12 Bilateral Dialogues U.S.- India Health Initiative (HHS and MHFW) The High Technology Cooperation Group s - Life Sciences and Biotechnology Working Group provides a framework for discussing issues of mutual concern facilitate and promote high-technology trade Commercial Dialogue Public-private - facilitate trade across a broad range of economic sectors Trade Forum Policy Led by USTR, with Commerce participation Promotes policies to increase market access and enhances opportunities for trade and investments 12
13 Thank you! Contact Information Richard Paddock Director, Med Tech International Trade Administration (202) Ms. Ruma Chatterjee Senior Commercial Specialist Market Access and Compliance office New Delhi Phone:
GUIDELINES FOR IMPORT AND MANUFACTURE OF MEDICAL DEVICES
GUIDELINES FOR IMPORT AND MANUFACTURE OF MEDICAL DEVICES The Ministry of Health and F.W. under Gazette notification S.O. 1468 (E) dated 6/10/2005 declared the following sterile devices to be considered
More informationRAPS ONLINE UNIVERSITY
RAPS ONLINE UNIVERSITY Practical education and training for business success. For regulatory professionals, there is only one name to know and trust for online education and training RAPS Online University.
More informationDRUG SAFETY AND HUMAN RESOURCES SUBSECTORS ANALYSIS
Additional Financing of Fourth Health Sector Development Project (RRP MON 41243) DRUG SAFETY AND HUMAN RESOURCES SUBSECTORS ANALYSIS I. Drug Safety Subsector A. Drug Safety Issues 1. Lack of coordination.
More informationHong Kong Joint Venture Agreements
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness,
More informationNovember 03, 2009. Via Electronic Mail to www.regulations.gov
November 03, 2009 Via Electronic Mail to www.regulations.gov Ms. Gloria Blue Executive Secretary, Trade Policy Staff Committee Office of the U.S. Trade Representative 600 17th Street, N.W. Washington,
More informationTRANSATLANTIC TRADE AND INVESTMENT PARTNERSHIP
DISCLAIMER: The EU reserves the right to make subsequent modifications to this text and to complement its proposals at a later stage, by modifying, supplementing or withdrawing all, or any part, at any
More informationSAMPLE. Asia-Pacific Interventional Cardiology Procedures Outlook to 2020. Reference Code: GDMECR0061PDB. Publication Date: May 2014
Asia-Pacific Interventional Cardiology Procedures Outlook to 2020 Reference Code: GDMECR0061PDB Publication Date: May 2014 Page 1 1 Table of Contents 1 Table of Contents... 2 1.1 List of Tables... 4 1.2
More informationHealthcare, Regulatory and Reimbursement Landscape - Australia
Brochure More information from http://www.researchandmarkets.com/reports/2207850/ Healthcare, Regulatory and Reimbursement Landscape - Australia Description: Healthcare, Regulatory and Reimbursement Landscape
More informationPlamena Entcheva-Dimitrov, PhD, RAC On-line Course. www.preferredregulatoryconsulting.com 1
Plamena Entcheva-Dimitrov, PhD, RAC On-line Course 1 The Preferred Regulatory Consulting content in this presentation is copyright protected under United States law and applicable international copyright
More informationSincerely yours, Kathryn Hurford Associate Director, Policy
8 July 2005 Malaysia FTA Taskforce Department of Foreign Affairs and Trade R. G. Casey Building, John McEwen Crescent BARTON ACT 0221 Dear Sir/Madam, Engineers Australia is the peak body for engineering
More informationMSD Information Technology Global Innovation Center. Digitization and Health Information Transparency
MSD Information Technology Global Innovation Center Digitization and Health Information Transparency 10 February 2014 1 We are seeking energetic, forward thinking graduates to join our Information Technology
More informationNRA FUNCTION IN CONTROLLING VACCINES IN CLINICAL TRIAL AND MARKETING AUTHORIZATION INDONESIA 2013 DVI MEETING 9 11 APRIL 2013 1
NRA FUNCTION IN CONTROLLING VACCINES IN CLINICAL TRIAL AND MARKETING AUTHORIZATION INDONESIA 2013 DVI MEETING 9 11 APRIL 2013 1 2 The National Agency of Drug and Food Control (NA-DFC) is a non departmental
More informationThe Medical Device Industry in Korea: Strategies for Market Entry
The Industry in Korea: Strategies Seth J. Goldenberg, Senior Principal Scientist, NAMSA; Yongha Na, Director, Medipert Regulatory NAMSA Whitepaper #09 06/2014 Seth J. Goldenberg, PhD (sgoldenberg@namsa.com)
More informationMed-Info. Introduction to Korean Medical Device regulations. TÜV SÜD Product Service GmbH
Med-Info International expert information for the Medical Device industry Introduction to Korean Medical Device regulations The Ministry of Health and Welfare (MHW) is the healthcare agency having overall
More informationMed-Info Regular Information Bulletins for the Medical Device Industry
Med-Info Regular Information Bulletins for the Medical Device Industry Product Service Globalization of Medical Device Approval Mutual Recognition Agreements (MRA) between the EU and the USA and Australia
More informationBig Data in Health Sciences An India Prospective
Big Data in Health Sciences An India Prospective Government Industry Dialogue 24 th Nov 2013 1 Views presented are Individual views only 2 Healthcare Ecosystem Stakeholders and Influencers Drugs and Devices
More informationComparison of Healthcare Systems in Selected Economies Part I
APPENDIX D COMPARISON WITH OVERSEAS ECONOMIES HEALTHCARE FINANCING ARRANGEMENTS Table D.1 Comparison of Healthcare Systems in Selected Economies Part I Predominant funding source Hong Kong Australia Canada
More informationHealth Services - A Short Glance of Prospects
UNCTAD-WHO Joint Publication International Trade in Health Services A Development Perspective Geneva, 1998 [Doc. symbol: UNCTAD/ITCD/TSB/5 - WHO/TFHE/98.1] 4. OPPORTUNITIES AND CHALLENGES FOR DEVELOPING
More informationPromoting innovation and improving access
NATIONAL ASSESSMENT TOOL TO ASSIST MEMBER STATES IN IMPLEMENTING THE GLOBAL STRATEGY AND PLAN OF ACTION ON PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY Promoting innovation and improving access
More informationIndia s Export Control System: Inter-Agency Cooperation and Coordination
India s Export Control System: Inter-Agency Cooperation and Coordination Government of India Outline of presentation Inter-agency cooperation and coordination in: Licensing Policy and Enforcement Implementation
More information2019 Healthcare That Works for All
2019 Healthcare That Works for All This paper is one of a series describing what a decade of successful change in healthcare could look like in 2019. Each paper focuses on one aspect of healthcare. To
More informationMasters Learning mode (Форма обучения)
Program Title (Название программы): Pharmacology Degree (Степень) Masters Learning mode (Форма обучения) Full-time and part-time Duration of study (Продолжительность программы) 2 years (4 years part time)
More informationOPEN MARKETS FOR INTERNATIONAL TRADE AND INVESTMENT
OPEN MARKETS FOR INTERNATIONAL TRADE AND INVESTMENT Fast Facts In 2008, more than 38 million jobs in America more than one in five depended on international trade exports and imports. 1 In 1992, a year
More informationINDEPENDANT CONSULTING FOR QUALITY AND REGULATORY AFFAIRS EXPERTS FOR MEDICAL DEVICES
INDEPENDANT CONSULTING FOR QUALITY AND REGULATORY AFFAIRS EXPERTS FOR MEDICAL DEVICES REFERENCES ADEQUAT EXPERTISE cooperates from now with companies which are looking for simple and useful solutions,
More informationA clinical research organization
A clinical research organization About Us State of art facility. All clinical trials carried out in accordance with ICH GCP guidelines. Quality services within stipulated time period. Team of experienced
More informationUS Regulations for Import and Export of Cell Therapy Products
US Regulations for Import and Export of Cell Therapy Products Kurt Gunter, MD U Minnesota UCB Transplants (2001-2007)* Total units: 790 Number US banks: 19 Number non-us banks: 12 % units from non-us banks:
More informationTürkiye İlaç ve Tıbbi Cihaz Kurumu
w w w. t i t c k. g o v. t r TURKISH MEDICINES AND MEDICAL DEVICES AGENCY Gulsen ONER, Pharm. M.Sc. Melda KECIK, Pharm. M.Sc. WHO Technical Briefing Seminar, November 2014 OUTLINE I. About Turkey II. About
More informationValue added services of pharmaceutical fullline wholesalers. Contact GIRP for discussing partnerships + 32 2 777 99 77 girp@girp.
Value added services of pharmaceutical fullline wholesalers Contact GIRP for discussing partnerships + 32 2 777 99 77 girp@girp.org Selected examples from GIRP s integrated member companies: Please note
More informationThe first round of TPP negotiations was held in Melbourne in March 2010.
AN INTRODUCTION History The Trans-Pacific Partnership (TPP) builds from the Trans-Pacific Strategic Economic Partnership Agreement (P4) between Brunei, Chile, New Zealand and Singapore which entered into
More informationThe objectives of the Sri Lankan National Medicinal Drug Policy are
NATIONAL MEDICINAL DRUG POLICY FOR SRI LANKA Preamble Sri Lanka had a partly written Drug Policy from the 1960s. It was written as elements of a policy, beginning from selection of drugs for the government
More informationCanadian Regulations Safety of Human Cells, Tissues and Organs (CTO) for Transplantation
Canadian Regulations Safety of Human Cells, Tissues and Organs (CTO) for Transplantation Presentation to the American Association of Tissue Banks Savannah, Georgia March 2008 Health Canada Update Marianne
More informationHow the International Trade Administration (ITA) can help you!
How the International Trade Administration (ITA) can help you! What is the International Trade Administration? Our Mission Statement: The International Trade Administration (ITA) strengthens the competitiveness
More informationPDP Funders Group Briefing Paper 3. 1. Background. 2. Methods
PRODUCT DEVELOPMENT PARTNERSHIPS (PDPS): WORKING TOGETHER: COLLABORATIONS BETWEEN PDPS AND PHARMACEUTICAL BIOTECHNOLOGY COMPANIES BASED IN EMERGING AND DEVELOPING ECONOMIES 1. Background Product Development
More informationTHE BIOTECH & PHARMACEUTICAL INDUSTRY
THE BIOTECH & PHARMACEUTICAL INDUSTRY ESSENTIAL CAREERS INFORMATION CALUM LECKIE KATIE BISARO CAREERS CONSULTANTS What we will cover Sector overview Types of role Graduate recruitment trends and issues
More informationOpportunities in Indian Healthcare Industry
Opportunities in Indian Healthcare Industry India - An Introduction Population States/UTs Geographical Area Languages recognised Business language Per Capita Income** GDP** Over 1 billion 35 3.3mnsqkms
More informationUS China Renewable Energy Cooperation: Status, Challenges and Opportunities
US China Renewable Energy Cooperation: Status, Challenges and Opportunities Joanna Lewis, Ph.D. Edmund A. Walsh School of Foreign Service Georgetown University Presented at the China Environment Forum,
More informationRisk Management Plan (RMP) Guidance (Draft)
Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Pharmaceuticals and Medical Devices Agency Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour
More informationUsing Clinical Registries to Create Evidence-based Health Care Policy : Experiences from Ontario, Canada
Using Clinical Registries to Create Evidence-based Health Care Policy : Experiences from Ontario, Canada April 2009 Jack V. Tu, MD PhD FRCPC CANADA RESEARCH CHAIR IN HEALTH SERVICES RESEARCH Institute
More informationDrug Re-Examination/Data Exclusivity in JAPAN and Neighboring Countries
Japan Pharmaceutical Manufacturers & Association Drug Re-Examination/Data Exclusivity in JAPAN and Neighboring Countries AIPPI Forum & ExCo Workshop Pharma IV September 6, 2013 at Helsinki Yoichi OKUMURA
More informationChinese Nonproliferation Policy and Export Control Practice Taibei August 28, 2013
Chinese Nonproliferation Policy and Export Control Practice Taibei August 28, 2013 LI Hong Vice President & Secretary General China Arms Control & Disarmament Association (CACDA) 1 China s View on Proliferation
More informationMartin Hemmert. Korea University Business School
Martin Hemmert Korea University Business School Contents 1 The Concept of Innovation Systems 2 The Korean Innovation System: Overview 3 The Parts of the Korean Innovation System 4 Conclusions and Implications
More informationJapan. Type of Market: Large/Challenging. Overall Rank. 2015 ITA Health IT Top Markets Report 35
Japan Type of Market: Large/Challenging Japan ranked as the top country in this Health IT Top Markets Report, with a favorable demographic profile for Health IT, a largely urbanized population, and sizable
More informationMedical Devices: CE Marking Step-by Step
Medical Devices: CE Marking Step-by Step Sylvia Mohr Standards Specialist U.S. Mission to the European Union 1 Introduction CE marking in 8 Steps Overview intended purpose - technical documentation classification
More informationREACH-like regulations around the world. Dr. Adriana Jalba Manager, International Chemicals Management (ICM) Cefic
REACH-like regulations around the world Dr. Adriana Jalba Manager, International Chemicals Management (ICM) Cefic Content Global trends and issues of concern Concept of recent REACH-like chemical control
More informationGeneral Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff
General Wellness: Policy for Low Risk Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document
More informationJapan PMDA and CDISC Standards. Yuki Ando Senior Scientist for Biostatistics Pharmaceuticals and Medical Devices Agency (PMDA)
Japan PMDA and CDISC Standards Yuki Ando Senior Scientist for Biostatistics Pharmaceuticals and Medical Devices Agency (PMDA) CDISC 2012 1 Outline New drug review process in Japan Task force for advanced
More informationDrug Distribution Management Policy in Korea
Drug Distribution Management Policy in Korea Regarding introduction of Drug Serial Number System (Serialization) Ministry of Health and Welfare Drug Distribution Management Policy Overview Policy Objectives
More informationNATIONAL TRADE NEGOTIATING TRAINING PROJECT
NATIONAL TRADE NEGOTIATING TRAINING PROJECT Organized by International Institute for Trade and Development (ITD) in cooperation with partners under the MOU: the United Nations Economic and Social Commission
More informationRegulatory Considerations for Conducting Clinical Trials In India
Regulatory Considerations for Conducting Clinical Trials In India By Mukesh Kumar, PhD & Surinder Kher, MD In the last few years, there has been increasing interest in the pharmaceutical industry in outsourcing
More informationExperience a higher excellence.
Experience a higher excellence. Quality Care Advanced Technologies For more detail, visit: www.medical-excellence-japan.org Japanese Hospitality Published by: Medical Excellence JAPAN Japan s healthcare
More informationChapter: 2 Health care Industry in India
Chapter: 2 Health care Industry in India 2.1 Health care Environment in India Indian healthcare industry, unlike other industries, stands untouched by recession. There had been a steady growth in this
More informationACC San Diego Chapter
ACC San Diego Chapter Biomedical and Technology Collaborations with Chinese Companies: Legal and Cultural Challenges October 2012 DLA Piper Overview Our Firm 4,200 lawyers in 77 offices and 33 countries
More informationSTATE BOARD OF COMMUNITY COLLEGES. CURRICULUM PROGRAM APPLICATION (New to the System)
Attachment PROG 5 STATE BOARD OF COMMUNITY COLLEGES CURRICULUM PROGRAM APPLICATION (New to the System) The State Board of Community Colleges is asked to approve the curriculum program listed on the condition
More informationHealthcare Sector Development: Russia s Top Priority. Miguel Hernandez Commercial Officer U.S. Commercial Service U.S. Embassy Moscow 2014
Healthcare Sector Development: Russia s Top Priority Miguel Hernandez Commercial Officer U.S. Commercial Service U.S. Embassy Moscow 2014 Russia - Advantages The consumer boom has ended but growth should
More informationPrivate Health Insurance Legislation Amendment Bill (No. 2) 2009
Parliament of Australia Department of Parliamentary Services Parliamentary Library Information, analysis and advice for the Parliament BILLS DIGEST www.aph.gov.au/library 19 October 2009, no. 40, 2009
More informationAPPENDIX C HONG KONG S CURRENT HEALTHCARE FINANCING ARRANGEMENTS. Public and Private Healthcare Expenditures
APPENDIX C HONG KONG S CURRENT HEALTHCARE FINANCING ARRANGEMENTS and Healthcare Expenditures C.1 Apart from the dedication of our healthcare professionals, the current healthcare system is also the cumulative
More informationHow To Understand The Health Care System In The United States
Medicare Payments And Its Relationship To The U.S. Healthcare System Stuart H. Altman, Ph.D. Sol C. Chaikin Professor of National Health Policy Brandeis University Should Medicare Focus Only on The Functioning
More informationInviting Possibilities. Healthcare. Cover Page- Healthcare Sector Report.indd 1
Inviting Possibilities Healthcare Cover Page- Healthcare Sector Report.indd 1 7/30/13 1:4 PM TABLE OF CONTENTS Overview of Dubai's Healthcare Industry Investment opportunities Medical research and development
More informationCloud Computing: An enabler of IT in Indian Healthcare Sector. Media Briefing September 29, 2010
Cloud Computing: An enabler of IT in Indian Healthcare Sector Media Briefing September 29, 2010 Executive Summary Indian healthcare spending is about 4.1 percent of its GDP. The Indian healthcare industry
More informationThe Regulation of Medical Devices in the UK
The Regulation of Medical Devices in the UK 1. What are the main requirements for a medical device to enter into the market and how are they regulated? Are there any licensing, marketing authorisation,
More informationBy Natalia Wilson, MD, MPH
White Paper The value of unique device identification across healthcare By Natalia Wilson, MD, MPH Executive summary The Unique Device Identification (UDI) System Proposed Rule was published by the U.S.
More informationFramework for rapid assessment of the pharmaceutical sector in a given country
Framework for rapid assessment of the pharmaceutical sector in a given country Prepared for Flagship Course (Health) Glossary: EU GLP GMP HIF IMS INN MOH NGO OEBIG OECD OTC PER R&D Rx TRIPS VAT WHO European
More informationChina s rising needs and opportunities. George Liu La Trobe University c.liu@latrobe.edu.au
China s rising needs and opportunities George Liu La Trobe University c.liu@latrobe.edu.au Healthcare market in China Consumer demands Service capacity Governmental control Healthcare demands Ageing population
More informationEU initiative on the Access to the EU Public Procurement markets
EU initiative on the Access to the EU Public Procurement markets A Tool to Regain Leverage Anders C. Jessen Head of Unit, Public Procurement and Intellectual Property, DG Trade, European Commission Content
More information2013 HOUSE OF DELEGATES ACTIONS GOVERNMENTAL AFFAIRS AND LEGAL MATTERS (B)
2013 HOUSE OF DELEGATES ACTIONS GOVERNMENTAL AFFAIRS AND LEGAL MATTERS (B) 100 Certificate of Need for Ambulatory Surgery Centers Owned by Physicians RESOLVED, that the Medical Society of the State of
More informationIntroduction to the CTA & NDA process in China
Introduction to the CTA & NDA process in China Jie Zhang, Regulatory Affairs, Abbott China Presented by: Peter van Amsterdam, Clinical Pharmacology & Bioanalytics, Abbott Netherlands EBF/CBF China Days,
More informationSpeakUP. Help prevent medical test mistakes
SpeakUP TM Help prevent medical test mistakes Help prevent medical test mistakes Medical tests and laboratory tests are important aids for doctors. However, sometimes the wrong test is ordered. Or the
More informationAbt Associates Inc. Abt Associates Clinical Trials Comprehensive clinical research services
Abt Associates Inc. Abt Associates Clinical Trials Comprehensive clinical research services Providing a wide range of clinical research services Abt Associates Clinical Trials (AACT) is dedicated to providing
More informationStephen Dibert Global Practice Lead Life Sciences Foreign Affairs, Trade and Development Canada JBA Seminar - February, 2015
Life Sciences Industry in Canada Stephen Dibert Global Practice Lead Life Sciences Foreign Affairs, Trade and Development Canada JBA Seminar - February, 2015 Life Sciences in Canada Canadian life sciences
More informationCreating an international pharmacy-led healthcare group
3 October 2005 Alliance Boots plc 1 Legal disclaimer This presentation does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy any security, nor shall there be any
More informationInvesting in the United States
Investing in the United States 13 May 2015 ehealth Week 2015 Global Markets: Tools for Transatlantic Trade Kim Tuminaro Senior Trade Officer U.S. Department of State SelectUSA.gov U.S. Investment and Business
More informationPharmacovigilance and the Internet: A Call for Change
Pharmacovigilance and the Internet: A Call for Change A white paper from the ABPI Pharmacovigilance Expert Network 13 June 2011 Page 2 of 6 Pharmacovigilance and the Internet: A Call for Change (ABPI)
More informationInstitution Building and Human Resource Development for Managing Trade and Industry Logistics. Hungary's Success Story. Hans J.
March 1995 Transport No. PS-11 TRANSPORTATION, WATER AND URBAN DEVELOPMENT DEPARTMENT THE WORLD BANK Institution Building and Human Resource Development for Managing Trade and Industry Logistics Hungary's
More informationREIMBURSEMENT UNRAVELLED: Australia s schizophrenic device coverage system
REIMBURSEMENT UNRAVELLED: Australia s schizophrenic device coverage system Clinica provides you with up to the minute coverage and opinion on company, product, market and regulatory developments as well
More informationChina s 12th Five-Year Plan: Healthcare sector
China s 12th Five-Year Plan: Healthcare sector May 2011 KPMG CHINA One of the guiding principles of the 12th Five-Year Plan (5YP) is inclusive growth : helping ensure that the benefits of the country s
More informationNormand Laberge Vice-President Regulatory & Scientific Affairs Rx&D. Globalization of Clinical Research: Trends & Implications for Canada
Normand Laberge Vice-President Regulatory & Scientific Affairs Rx&D Globalization of Clinical Research: Trends & Implications for Success Rates by Phase and Therapeutic Area Source: Nature Reviews Drug
More information9/13/2011. Miscellaneous Current Topics in Healthcare Professional Liability. Antitrust Notice. Table of Contents. Cyber Liability.
Miscellaneous Current Topics in Healthcare Professional Liability Josh Zirin, FCAS, MAAA Antitrust Notice The Casualty Actuarial Society is committed to adhering strictly to the letter and spirit of the
More informationSchool of Pharmacy TEMPLE UNIVERSITY
School of Pharmacy TEMPLE UNIVERSITY Regulatory Affairs and Quality Assurance Graduate Program Te mple Unive rsity School of Pharmacy Re gulatory Affairs and Quality Assurance Graduate Program 4 25 Comme
More informationTHE ORGANISATION AND FINANCING OF HEALTH CARE SYSTEM IN LATVIA
THE ORGANISATION AND FINANCING OF HEALTH CARE SYSTEM IN LATVIA Eriks Mikitis Ministry of Health of the Republic of Latvia Department of Health Care Director General facts, financial resources Ministry
More informationLean Strategies for Laboratory Testing
Microrite, Inc. brings you this unique learning experience in Lean Strategies for Laboratory Testing; Part of Microrite s step-by-step webinar series. Lean Strategies for Laboratory Testing erience in
More informationHow companies leverage quality and quality certifications to achieve competitive advantage
How companies leverage quality and quality certifications to achieve competitive advantage Eize de Boer Systems & Services Certification International Business Development Manager Pharma Supply Chain for
More information2/15/2015 HEALTHCARE ACCREDITATION: WHAT IT MEANS TO YOU HEALTHCARE ACCREDITATION WHAT IT MEANS TO YOU
HEALTHCARE ACCREDITATION: WHAT IT MEANS TO YOU D avid G o u rley, R R T, MH A, FAAR C E xecu tive Directo r, Regulatory Affairs Chilton Hospital Po m p ton Plains, New Jersey HEALTHCARE ACCREDITATION:
More informationSnapshot Report on Russia s Healthcare Infrastructure Industry
Snapshot Report on Russia s Healthcare Infrastructure Industry According to UK Trade & Investment report, Russia will spend US$ 15bn in next 2 years to modernize its healthcare system. (Source: UK Trade
More informationThe science of medicine. The compassion to heal.
A PATIENT S GUIDE TO ELECTROPHYSIOLOGY STUDIES OF THE HEART The science of medicine. The compassion to heal. This teaching booklet is designed to introduce you to electrophysiology studies of the heart.
More informationEU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE
EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE Purpose 1. The Clinical Trials Directive 2001/20/EC heralds certain additional responsibilities for the Medicines and Healthcare
More informationEngineering Nanomedical Systems
BME 695 November 8, 2011 Engineering Nanomedical Systems Lecture 15 GMP and issues of quality control manufacture of nanodelivery systems James F. Leary, Ph.D. SVM Endowed Professor of Nanomedicine Professor
More informationHealthcare and Dental Industry in. Indian Dental Association. India
Healthcare and Dental Industry in Indian Dental Association India India is now among the top 1 to 3 in most parameters: GDP, size of economy, IT, pool of scientific manpower, space, eco-protection measures,
More informationHow Industry Might Use Free Trade and Investment Agreements to Oppose Smokefree 2025
How Industry Might Use Free Trade and Investment Agreements to Oppose Smokefree 2025 Professor Jane Kelsey, School of Law, The University of Auckland, NZ, 8 November 2012 Focus of this presentation 1.
More informationApplication for Accreditation of Foreign Manufacturers
Application for Accreditation of Foreign Manufacturers (This English document is only for reference purpose. In case of any discrepancy, the Japanese text shall prevail. For further information, please
More informationPOST-MASTER S CERTIFICATES in ADVANCED QUALITY ASSURANCE or REGULATORY AFFAIRS
Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034 Phone: 267.468.8560 Fax: 267.468.8565 POST-MASTER S CERTIFICATES in ADVANCED QUALITY ASSURANCE or REGULATORY
More informationTemple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034. Phone: 267.468.8560 Fax: 267.468.
Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Phone: 267.468.8560 Fax: 267.468.8565 POST-MASTER S CERTIFICATE in GLOBAL PHARMACOVIGILANCE: BENEFIT-RISK ASSESSMENT Temple created
More informationSingapore Medical Tourism Industry Outlook to 2015
Brochure More information from http://www.researchandmarkets.com/reports/2013589/ Singapore Medical Tourism Industry Outlook to 2015 Description: The report titled Singapore Medical Tourism Industry Outlook
More informationAustralian Reimbursement
Australian Reimbursement The true costs (and benefits) of market entry Hosted by Brandwood Biomedical 21 April 2015 +61 2 9906 2984 help@brandwoodbiomedical.com www.brandwoodbiomedical.com BRANDWOOD:BIOMEDICAL
More informationAustralia Life Sciences Market
Australia Life Sciences Market Monique Roos, Commercial Specialist U.S. Commercial Service, Sydney, Australia November 2014 Geographical Size Population Density More than 80% of population in this ring
More informationRevised Action Plan of the Tripartite. (Japan, the People s Republic of China, and the Republic of Korea) Customs Cooperation
Revised Action Plan of the Tripartite (Japan, the People s Republic of China, and the Republic of Korea) Customs Cooperation The Customs and Tariff Bureau of Ministry of Finance, Japan, the General Administration
More informationAMP to acquire 19.9% of China Life Pension Company
30 October 2014 AMP to acquire 19.9% of China Life Pension Company AMP Limited, Australia and New Zealand s leading independent wealth management business, announced it has agreed to acquire a 19.99 per
More informationA STRATEGY FOR ASEAN. 22 nd to 23 rd August, 2013 Shangri La Hotel Singapore HEALTHCARE. Organiser. Co-Organiser
A STRATEGY FOR ASEAN 22 nd to 23 rd August, 2013 Shangri La Hotel HEALTHCARE Organiser Co-Organiser HEALTHCARE Moderator Dr. Penny O Hara Partner, Accenture Organiser Co-Organiser HEALTHCARE Sector Chair
More informationPROMOTING ACCESS AND MEDICAL INNOVATION: INTERSECTIONS BETWEEN PUBLIC HEALTH, INTELLECTUAL PROPERTY AND TRADE
PROMOTING ACCESS AND MEDICAL INNOVATION: INTERSECTIONS BETWEEN PUBLIC HEALTH, INTELLECTUAL PROPERTY AND TRADE Joint study by the WHO, WIPO and WTO Secretariats Outline and overview The WHO, WIPO and the
More informationMedical Devices: An Introduction to the Regulatory Regime in China and Options for Foreign Investors in the Medical Device Sector
Medical Devices: An Introduction to the Regulatory Regime in China and Options for Foreign Investors in the Medical Device Sector September 16 2011 Strategic alliance with McDermott Will & Emery Boston
More informationMedical Devices. Driving Growth With Transformational Technology
Medical Devices Driving Growth With Transformational Technology Forward-Looking Statement Some statements in this presentation may be forward-looking statements for purposes of the Private Securities Litigation
More information