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

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

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

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

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

7. GUIDELINES IDRG International Development of Regulatory Globalization

8. DATA REQUIREMENTS IDRG International Development of Regulatory Globalization

9. PRESUBMISSION CONSULTATION IDRG International Development of Regulatory Globalization  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 request form product specification form product specification form list of uses list of uses draft label/use pattern draft label/use pattern

10. PRESUBMISSION CONSULTATION IDRG International Development of Regulatory Globalization CROPPEST ALMONDSEMPOASCA LYBICA APRICOTSEMPOASCA LYBICA PLUMS-EUROPEANEMPOASCA LYBICA PEACHESEMPOASCA LYBICA GRAPES: GENERALEMPOASCA LYBICA CHERRIESEMPOASCA LYBICA NECTARINESEMPOASCA LYBICA COTTONBEMISIA TABACI CUCUMBERSBEMISIA TABACI EGGPLANT/AUBERGINEBEMISIA TABACI MELONBEMISIA TABACI PEPPER-BELL/SWEETBEMISIA TABACI SQUASH-BUTTERNUTBEMISIA TABACI TOMATOESBEMISIA TABACI WATERMELONSBEMISIA TABACI STRAWBERRIESHEMIPTERA

11. PRESUBMISSION CONSULTATION IDRG International Development of Regulatory Globalization

12. STUDY PROTOCOLS IDRG International Development of Regulatory Globalization

13. SUBMISSION TEMPLATES IDRG International Development of Regulatory Globalization

14. SUBMISSION FORMAT IDRG International Development of Regulatory Globalization

15. REVIEW TEMPLATES IDRG International Development of Regulatory Globalization

16. UNIFORM PRINCIPLES IDRG International Development of Regulatory Globalization

17. FEES & TIMELINES IDRG International Development of Regulatory Globalization “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.

18. OECD

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

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

21. DISCUSSION IDRG