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GLOBAL REGISTRATION of BIOPESTICIDES: A SYMPHONY. IDRG. Imme Gerke, PhD Global Regulatory Strategist. International Development of Regulatory Globalization. TAKING A LEAP OF FAITH. IDRG. International Development of Regulatory Globalization. THE PEOPLE. growers m arketers p rocessors

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  1. GLOBAL REGISTRATION of BIOPESTICIDES: A SYMPHONY IDRG Imme Gerke, PhD Global Regulatory Strategist International Development of Regulatory Globalization

  2. TAKING A LEAP OF FAITH IDRG International Development of Regulatory Globalization

  3. THE PEOPLE • growers • marketers • processors • landscapers • exterminators • …… • compliance • coordination • chemistry/physics • toxicology (human) • toxicology (env.) • exposure • env. fate • value • policy • …… globally nationally Growers Regulators regionally > 200 countries Feed Fiber Registrants Scientists • research • business • finance • marketing • legal • production • quality control • commercialization • …… Public Land Public Health 10,000 • chemists • biologists • agronomists • engineers • toxicologists • ecologists • …… Food

  4. SYMPHONY ‘The director is the only musician who makes no sound.’ (Benjamin Zander) IDRG International Development of Regulatory Globalization

  5. SONG SHEET • guidelines • data requirements • presubmission consultations • study protocols • submission templates • format • review templates • uniform principles IDRG International Development of Regulatory Globalization

  6. GUIDELINES IDRG International Development of Regulatory Globalization

  7. DATA REQUIREMENTS IDRG International Development of Regulatory Globalization

  8. PRESUBMISSION CONSULTATION • many countries • electronic and/or face-to-face • free or fee • proposed workshares and joint reviews allow regulators to harmonize further • resolve differences prior to reaching the market • application • request form • product specification form • list of uses • draft label/use pattern IDRG International Development of Regulatory Globalization

  9. PRESUBMISSION CONSULTATION IDRG International Development of Regulatory Globalization

  10. PRESUBMISSION CONSULTATION IDRG International Development of Regulatory Globalization

  11. STUDY PROTOCOLS IDRG International Development of Regulatory Globalization

  12. SUBMISSION TEMPLATES IDRG International Development of Regulatory Globalization

  13. SUBMISSION FORMAT IDRG International Development of Regulatory Globalization

  14. REVIEW TEMPLATES IDRG International Development of Regulatory Globalization

  15. UNIFORM PRINCIPLES IDRG International Development of Regulatory Globalization

  16. FEES & TIMELINES “Fees and timelines vary widely.” We need to check our assumptions. Fees are calculated in different ways: by study to be reviewed, by submission type, by MRL, by maintenance fee, with fee reduction programs … or are effected by exchange rates. Timelines in Canada appear to be longer than in the US but therefore there is no waiting time to get onto a schedule. The EU reviews AI and EP successively while NA reviews simultaneously but therefore the individual intervals are shorter. IDRG International Development of Regulatory Globalization

  17. OECD

  18. GLOBAL DATABASE OF REGISTERED PRODUCTS AND USES ... (EuropeanCountries) ... (Eurasian Countries) ... (AsianCountries) … (North American Counties) Global PRODUCTS … (Australia) … (Central American Countries) ... (African Countries) ... (South American Countries) IDRG International Development of Regulatory Globalization

  19. GLOBAL NEEDS DATABASE ... (EuropeanCountries) MUN (Great Britain) ... (AsianCountries) PMC (Canada) Global NEEDS MULO (Australia) ... (African Countries) IR4 (USA) ... (South American Countries) IDRG International Development of Regulatory Globalization

  20. DISCUSSION ?! IDRG International Development of Regulatory Globalization

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