Boston

 Boston Chapter Meeting

 

Thank you for a great year! The SOCRA Boston chapter is officially on summer vacation. We will start up again in the end of September. A meeting notification email will be sent out in the beginning of September with meeting details and schedule.

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The SOCRA Boston Chapter presents the June 3rd meeting:

IND/IDE Submissions from Start to Finish

Location: 1 Autumn Street, Auditorium B (in the basement), Boston Children's Hospital, Boston MA 02215. Contact Erica Denhoff, MPH, CCRP, Chair SOCRA Boston chapter, with any questions at Erica.Denhoff@gmail.com or 401-575-7898.

Time: 5pm-6pm

Speaker: – Ashley Kuniholm, CIP – Regulatory Specialist, Boston Children’s Hospital

Learning Objectives:

• Understand required components of initial IND and IDE applications in order to successfully submit to FDA.

• Understand continued submission and reporting requirements for maintenance of IND and IDE files.

• Discuss how to submit formal IND exemption and Study Risk Determination requests to FDA.

CE: 1 CEU available for SOCRA  members

 

Enjoy your summer! See you again in September!

 

ALL CHAPTER MEETINGS ARE FREE OF CHARGE, OPEN TO SOCRA MEMBERS AND THE PUBLIC, AND DO NOT REQUIRE PRE-REGISTRATION. SOCRA MEMBERS MAY CLAIM 1 CE FOR ATTENDANCE PER MEETING.