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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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Presentation Transcript
slide1

GLOBAL REGISTRATION of BIOPESTICIDES:

A SYMPHONY

IDRG

Imme Gerke, PhD

Global Regulatory Strategist

International Development of Regulatory Globalization

slide2

TAKING A LEAP OF FAITH

IDRG

International Development of Regulatory Globalization

the people
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

slide5

SYMPHONY

‘The director is the only musician who makes no sound.’

(Benjamin Zander)

IDRG

International Development of Regulatory Globalization

slide6

SONG SHEET

  • guidelines
  • data requirements
  • presubmission consultations
  • study protocols
  • submission templates
  • format
  • review templates
  • uniform principles

IDRG

International Development of Regulatory Globalization

slide7

GUIDELINES

IDRG

International Development of Regulatory Globalization

slide8

DATA REQUIREMENTS

IDRG

International Development of Regulatory Globalization

slide9

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

slide10

PRESUBMISSION CONSULTATION

IDRG

International Development of Regulatory Globalization

slide11

PRESUBMISSION CONSULTATION

IDRG

International Development of Regulatory Globalization

slide12

STUDY PROTOCOLS

IDRG

International Development of Regulatory Globalization

slide13

SUBMISSION TEMPLATES

IDRG

International Development of Regulatory Globalization

slide14

SUBMISSION FORMAT

IDRG

International Development of Regulatory Globalization

slide15

REVIEW TEMPLATES

IDRG

International Development of Regulatory Globalization

slide16

UNIFORM PRINCIPLES

IDRG

International Development of Regulatory Globalization

slide17

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

slide19

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

slide20

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

slide21

DISCUSSION

?!

IDRG

International Development of Regulatory Globalization