interested in learning more about Regulatory Affairs in the biotech and life sciences industries?

Welcome to SDRAN

SDRAN is a nonprofit organization dedicated to supporting our members through various educational and development programs for medical device and pharmaceutical industry professionals.

2026 RAC Preparatory Courses — Now Enrolling!

Join SDRAN's live and also recorded, instructor-led RAC Prep Study Groups and prepare for the Regulatory Affairs Certification (RAC) exam.

Enroll anytime during the course. 

If you miss a live session, you'll receive full Zoom recordings (available for 6 months) so you can catch up at your convenience.

2026 RAC Device Preparatory Sessions

Schedule: Tuesdays, 6:00–8:00 PM (Pacific)
Dates: July 7 – August 25, 2026

Register for SDRAN's Device Course

2026 RAC Drug Preparatory Sessions

Schedule: Wednesdays, 6:00–8:00 PM (Pacific)
Dates: July 15 – August 26, 2026

Register for SDRAN's Drug Course

RECENT SDRAN EVENTS

SDRAN Virtual Program Event

Strategic FDA Engagement in Accelerated Pathways: Breakthrough, STeP, TAP & RAPID

Speaker: Michael Nilo
Former FDA Reviewer, President & Principal Consultant, Nilo Medical Consulting Group, LLC

Event Details

Date: Tuesday, May 19, 2026
Time: 12:00 PM – 1:00 PM PT
Location: Virtual Event via Zoom
Pre-registration is required.
The Zoom link will be emailed to registered attendees 1–2 days prior to the event.
Registration Fees
SDRAN Members: $15
Non-Members: $25
Register for this Event

Event Agenda

12:00 – 12:10 PM Welcome & Speaker Introduction
12:10 – 12:50 PM Speaker Presentation
12:50 – 1:00 PM Live Q&A

Program Overview

Early and strategic engagement with the FDA can significantly impact the success and timeline of innovative medical device development. This presentation will explore how companies can effectively navigate accelerated pathways including the Breakthrough Devices Program, STeP, TAP, and the newly announced RAPID pathway.

Attendees will gain practical insight into:

• Breakthrough Devices Program
• STeP and TAP pathways
• RAPID pathway strategy
• FDA and CMS engagement best practices
• Regulatory and reimbursement alignment
• Common sponsor pitfalls and how to avoid them
• Real-world examples and lessons learned

This session is ideal for professionals in Regulatory Affairs, Clinical Affairs, Product Development, and Medical Device Innovation.

Speaker Biography

Michael Nilo is the Founder and Principal Consultant of Nilo Medical Consulting Group, where he advises medical device, biotechnology, and pharmaceutical companies on regulatory strategy and FDA submissions.

A former FDA lead reviewer, Michael brings more than 15 years of experience spanning both the Agency and industry. He has supported numerous Breakthrough Designation, STeP, and TAP submissions and regularly represents industry during FDA Sprint discussions.

His expertise includes pre-IDE, 510(k), HDE, IDE, and PMA submissions, with specialized experience in cardiovascular and combination products.

Questions

For questions regarding the event or to pre-submit questions for the Q&A session, please contact:

General Info

Our Mailing Address:
SDRAN
P.O. Box 927595
San Diego, CA 92192-7595

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MEMBERSHIP

The SDRAN membership fee is:
$55.00 for 12 months

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Email

[email protected]

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MAILING ADDRESS
SDRAN
P.O. Box 927595
San Diego, CA 92192-7595

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