Understanding FDA Regulatory Requirements for an Investigational New Drug Application

Friday, February 23, 2024 at 12:00p.m. - 1:00p.m.

The Society of Clinical Research Associates (SoCRA), a non-profit and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities, presents "Understanding FDA Regulatory Requirements for an Investigational New Drug Application." 


During this presentation, we will discuss and explain the FDA investigational new drug submission process. The presenter, Tejashree Kulkarni, MS-RA, is an outstanding clinical researcher who has experience in regulatory drug and device clinical trials in oncology, cardiology, dermatology, infectious diseases, and surgery. 

The presentation will address:

  • Components of an investigational new drug application.
  • Significance of the process and requirements.
  • FDA communication structure.


This presentation will be led by Tejashree Kulkarni, MS-RA, research regulatory supervisor for clinical trials at the Lifespan Clinical Research Center.


This event is open to SoCRA and non-SoCRA members.

Cost: Admission to this presentation is free.
Credit: SoCRA Members may claim 1 CE towards SoCRA Recertification. 
Only SoCRA members will receive a certificate of attendance. 

For more information, please contact Brianna Forte at [email protected]

Meeting Information

Due to COVID-19 restrictions the meeting will be held remotely via Microsoft Teams.

Join the Teams Meeting

Meeting ID: 238 160 939 066
Passcode: WRg9XR

Or call in (audio only) 
+1 401-226-0907,,559615892# United States, Providence 
Phone Conference ID: 559 615 892# 

Location Information

Virtual via Teams