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Presented by Tom Gonzalez Divisional Vice President, Corporate Regulatory And Quality Science

Integration of Standards, Business and International Trade Operating Within a Complex Global Standards Environment for Medical Products. Presented by Tom Gonzalez Divisional Vice President, Corporate Regulatory And Quality Science Abbott Laboratories.

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Presented by Tom Gonzalez Divisional Vice President, Corporate Regulatory And Quality Science

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  1. Integration of Standards,Business and International TradeOperating Within a Complex Global Standards Environmentfor Medical Products Presented by Tom GonzalezDivisional Vice President,Corporate Regulatory And Quality Science Abbott Laboratories

  2. Global Standards Environmentfor Medical Products Typical activities for a global company selling products in over 100 countries

  3. This Represents ¼ of the Paperwork Required to Register a Pharma Product in the U.S. New Drug Application Metrics A full submission can be 1000 volumes of 350 pages Development of a new drug can take 8 years and $ 1B(U.S.) Every day of delay in product introduction represents $ 1M(U.S.) in lost sales

  4. Issues With Current Environment • Mutual Recognition Agreements are Difficult to Implement • Time to Market Across Countries is Delayed • Cost of Compliance is High • Product Availability is Impacted • Activities and Operations are Duplicated

  5. The good news is that of over $500 billion (U.S.) in worldwide sales, 85% is in the following regions North America 45% Europe 26% Japan 14% Global Standards Environmentfor Medical Products

  6. Where have we been? Where are we going? UNITED STATES EUROPE CANADA JAPAN AUSTRALIA APAC JAPAN EU U.S. HarmonizationEfforts CANADA LA • ISO • ICH • WHO • GHTF • MRA • Compendia AUSTRALIA ROW PACIFIC RIM LATIN AMERICA Opportunities for Harmonizationof Standards for Medical Products

  7. Current Global Regional Harmonization Efforts

  8. Harmonization:What can it mean for stakeholders? GOVERNMENT • Consistent global requirements for product registration, manufacturing practices and product performance standards, safety, and efficacy • Ability to develop mutual recognition agreements MEDICAL PROFESSIONALS/PATIENTS • Consistency in quality across global regions • Lower cost to consumers of medical products • Availability of therapeutic and diagnostic advances in technology

  9. Harmonization:What can it mean for manufacturers? • Increase market access and acceptance • Reduce time and cost of product development • Faster time to market • Reduce administrative and operational expenses • Reduce number of required registrations and inspections • Drive economics of scale • Portability of employee knowledge across global regions

  10. Potential Manufacturer’s Approach to Dealing with Harmonization • Global focus on pharmaceutical, device, and nutritional standards • Information/policy organization responsible for monitoring global standards developments • Active participation and leadership within standards and trade organizations • Sharing of standards development information to all company operating groups • Deployment of standards requirements through company-wide policy system

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