2015 IND/IDE and Reimbursements

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October 23, 2015

To introduce the basics of filing an Investigational New Drug (IND) Application with the FDA

To introduce the basics of filing an Investigational Device Exeption (IDE) Application with the FDA

To introduce the basics of reimbursement (coverage, codes, and payment) as these processes intersect in the current and evolving healthcare environment, including aspects of the Affordable Care Act, and will focus on creating an implementable strategy for a product so it can be successfully commericialized.


Target Audience

The target audience includes sponsor investigators, clinicians, students, academics, nurses, individuals from small companies, and is not limited to individuals at Boston University. We would like everyone to attend regardless of their affiliation. Clinical investigators and others on the study team responsible for submitting and maintaining FDA IND and/or IDE applications; regulatory affairs professionals; IRB staff.


Speakers

Erin O’Reilly, PhD, RAC

Assoc. Director, Regulatory Affairs
Translational Medicine Institute

Erika Segear Johnson, PhD, RAC

Regulatory Affairs Scientist
Duke Translational Medicine Institute

Jo Ellen Slurzberg

VP Global Health Policy
JR Associates


Agenda

8:00 – 8:30 am Check in and breakfast
8:30 – 8:45 am Welcome and introductions
8:45 – 9:45 am ND Application Process and Best Practices
9:45 – 10:00 am Break
10:00 – 11:15 am IND Application Process and Best Practices
11:15 – 12:15 pm IDE Application Process and Best Practices
12:15 – 12:30 pm Lunch Pick- Up
12:30 – 1:30 pm IDE Application Process and Best Practices
1:30 – 1:45 pm Break
1:45 – 3:15 pm eimbursement for Innovation


Location

Colloquium Room
Boston University Photonics Center
8 St Mary’s Street, Boston, MA

map

(listed in order of closet to venue)

Granby Lot
665 Commonwealth Avenue
Boston, MA 02215

Kenmore Lot
549 Commonwealth Avenue
Boston, MA 02215

Agganis Arena Lot
925 Commonwealth Avenue
Boston, MA 02215

pricing information

Train

Take the B line (Boston College) and get off at Boston University Central Station

Bus

57 Bus, T Stop St. Mary’s Street

BU Bus

St Mary’s Street (Inbound) or Marsh Plaza (Outbound)


This program is provided by the Boston University School of Medicine. Boston University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Boston University School of Medicine designates this live activity for a maximum of 6.5 AMA PRA category 1 Credits(1)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
To request reasonable accommodations for a disability please notify lenais@bu.edu, in writing, at least two weeks prior to the conference.

This event is supported by the BU Center for Future Technologies in Cancer Care, the BU Clinical Translational Science Institute (CTSI), and BUMC Office of Clinical Research, and the BU Department of Medicine, in collaboration with the Regulatory Affairs Office of the Duke Translational Medicine Institute.