Talks focused on regulatory issues and emerging topics in research. Regulatory Education and Events
At a glance
Opportunity for
  • Continuing education on regulatory compliance and emerging issues
Eligibility
  • Open to all (some sessions may open only to Harvard-affiliated researchers); sessions are geared to researchers, research staff, and/or institution officials and administrators.
Session Dates
  • Varies; see below for details

The Harvard Catalyst Regulatory Foundations, Ethics, and Law Program hosts events that focus on regulatory topics and emerging issues in the interdisciplinary conduct of research. The events series features local and national experts who offer guidance, present case studies, and engage participants in discussion on a range of topics of interest to researchers as well as research administrators and IRB members.

Upcoming Seminars

Workshop Series: Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator INDs and IDEs

February 14 & 15, 2018
Gordon Hall, Harvard Medical School

Investigational New Drug Workshop
February 14, 2018
9:00am-12:00 pm | Office hours: 1:00pm-3:00pm
Speaker: Kristen Foss, PhD, RAC (Duke University School of Medicine)
This workshop will offer best practices when conducting trials using FDA-approved and unapproved drugs or substances (including biologics). This half-day session will provide an overview of the IND application process and the regulatory obligations of the sponsor-investigator once an IND is filed with the FDA.

Investigational Device Exemption Workshop
February 15, 2018
9:00am-12:00 pm | Office hours: 1:00pm-3:00pm
Speaker: Kelly Lindblom, PhD (Duke University School of Medicine)
This workshop will offer best practices when conducting trials using FDA-approved and unapproved devices. This half-day session will provide overview of the marketing process for medical devices, the IDE application process, and the obligations of the sponsor-investigator once the IDE application is filed with the FDA.

These workshops are designed for those who are directly involved in conducting investigator-initiated trials: investigators, regulatory personnel, clinical research nurses, and clinical research associates.

Presenters will be available for one-on-one consultations to help answer specific IND/IDE-related questions.

For more information or to request to register, visit our registration page. Please note that space is limited, and priority will be given to senior researchers and staff.

Coffee/tea/snacks and lunch will be provided.

Co-sponsored by the Office of Regulatory Affairs and Quality at Duke University School of Medicine

Questions? Please email us.


The 2018 New England OHRP Research Community Forum

May 1-2, 2018
Joseph B. Martin Conference Center
Harvard Medical School

This Research Community Forum Informed Consent: Content, Communications and Emerging Technologies will bring together renowned experts, researchers, scientists, and regulatory professionals for a workshop on May 1, followed by a symposium on May 2.

Hosted by the 2018 New England OHRP Research Community Forum Planning Committee: The Office of Human Research Protections, Harvard Catalyst | The Harvard Clinical and Translational Science Center, Boston Children's Hospital, Boston University, Partners HealthCare, Tufts Clinical and Translational Science Center, and Yale Center for Clinical Investigation.

More information


Ongoing Opportunities

For IRBs

  • Onsite SBER Training and Education (Request Consultation)
    A customizable, case-based curriculum delivered and moderated by IRB experts.
  • IRB Visiting Program (Request schedule and more information)
    Local IRB members have the opportunity to observe the deliberations of another IRB to help identify best practices and innovative processes in the review of clinical and translational research.

For Investigators

  • Onsite SBER Training and Education (Request Consultation)
    A customizable, case-based curriculum delivered and moderated by IRB experts.
  • ClinicalTrials.gov Reporting (Request Consultation)
    Obtain assistance with required reporting to ClinicalTrials.gov from the Harvard Catalyst Biostatistics Program.