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The Westin Boston Waterfront

15 ago 2016 7:30 a.m. - 18 ago 2016 5:00 p.m.

425 Summer Street, Boston, MA 02210

Regulatory Affairs: The IND, NDA, and Postmarketing

Session 6: The IND in Detail - Items 8-10

Session Chair(s)

Drusilla  Scott, PHD, RAC

Drusilla Scott, PHD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., United States

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

  • IND Item 8: Nonclinical Pharmacology and Toxicology
  • IND Item 9: Previous Human Experience
  • IND Item 10: Additional Information

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