Module 1 2021

28/06/2021

In this presentation we have covered

• Regulatory Agency Interactions • What?

• Where? • When?

• Why? • How?

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Recommended references

 Scientific advice and protocol assistance - https://www.ema.europa.eu/en/human- regulatory/research-development/scientific-advice-protocol- assistance  Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants https://www.fda.gov/regulatory-information/search-fda- guidance-documents/formal-meetings-between-fda-and- sponsors-or-applicants-pdufa-products-guidance-industry  FAQ pre-IND meeting FDA - https://www.fda.gov/drugs/cder-small-business-industry- assistance-sbia/small-business-and-industry-assistance- frequently-asked-questions-pre-investigational-new-drug-ind  PMDA Consultations - https://www.pmda.go.jp/english/review- services/consultations/0002.html

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