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IDE Submissions Workshop - Spring 2019

May 15, 2019
Irvine, CA
Regulatory
Workshop

Click here to view the agenda

During this interactive workshop, FDA and industry experts will lead you through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required.

Agenda topics include:

  • The purpose of an IDE
  • Tips on making the best use of pre-submission meetings
  • Components of a successful IDE submission
  • Common errors and deficiencies in an IDE application
  • The ins and outs of BIMO inspections
  • Details about the regulatory requirements needed during trial conduct
  • And more!

Hotel Block Information
Courtyard Irvine Spectrum | 7955 Irvine Center Drive | Irvine, CA  92618

Speakers will include:

  • Jayna Stohlman, FDA
  • Gerard Prud’homme, Hogan Lovells
  • Yarmela Pavlovic, Hogan Lovells
  • Pamela Weagraff, IQVIA
  • Martin Hamilton, FDA
  • Jaap Laufer, Emergo by UL

Registration Fees

AdvaMed Member Registration: $995.00

Accel Member Registration: $595.00

Government and Non-Profit Registration: $595.00

Non-Member Registration: $1,295.00

Please review our cancellation policy here