Meet the Speakers

Bluestocking Health is pleased to invite you to exhibit at the Regulatory Alliance Forum. Every year, we host a riveting lineup of speakers and we know this year will not disappoint. All of our speakers are former FDA employees who love regulatory affairs! At RegAF, they will share their knowledge and extensive experience in areas from regulatory to quality assurance to startups in digital therapeutics to working closely with investors…just to name a few!

If you are interested in joining this unique conference as a speaker, please contact us now. Spaces are filling very quickly.

Meet Our 2027 RegAF Speakers

Meet Our Speakers

Rob Allen

Senior Director, RA - Biocompatibility
MCRA, an IQVIA business

Speaking Session: Biocompatibility for People Who Don't Want to Be Toxicologists

Alex Cadotte

VP, Head of Digital Health, AI, and Radiology Regulatory Affairs
MCRA, an IQVIA business

Speaking Session: Don't be Predetermined to Fail: PCCP Best Practices for Idiots

Keith Christopher

Director
JNPMEDI

Speaking Session: It’s Complicated: The FDA Regulatory Reality of Combination Products

Laura Gilmour

Founder & Principal Consultant
LG Strategies, LLC

Speaking Session: From Printer to Patient: Who’s the Manufacturer Now?

Melissa Hall

Founder and Principal Consultant
Statera Regulatory Consulting, LLC

Speaking Session: The 510(k) Was Never the Problem: Why bad regulatory strategy starts long before the submission.

Shannon Hoste

Founder & Principal Engineer
Hoste Consulting

Speaking Session: The User Did What?! Human Factors Lessons from FDA

Kristy Katzenmeyer-Pleuss

President
KP Medical Device Consulting LLC

Speaking Session: Biocompatibility: It's More Complicated Than “We've Used Silicone Forever”

Allison Kumar

Principal Consultant
Arina Consulting, LLC

Speaking Session: De Novo: The Middle Child of FDA Pathways

Véronique Li

Senior Manager
Exponent

Speaking Session: FDA Said No. Now What?

Pablo Morales

Principal Consultant & Founder
Morales MedTech Advisors

Speaking Session: PMA: Welcome to the Big Leagues

Michael Nilo

President & Principal Consultant
Nilo Medical Consulting Group

Speaking Session: There’s a Guidance for That! (Why following every FDA guidance document literally can still get you into trouble.)

Caroline Rhim

Principal Consultant
Evera Regulatory Advisors, LLC

Speaking Session: Your Pre-Sub Is Not Therapy: How to Get Useful Answers From FDA

Mike Ryan

Executive Vice President
ELIQUENT

Speaking Session: We Changed One Tiny Itty Bitty Thing… Do We Reaaaaally Need a New 510(k)?

Jay Vaishnav

Director Regulatory Affairs, Canon Medical Informatics
UCSC Silicon Valley Extension

Speaking Session: Is Your AI Baby Ugly?: What FDA Actually Wants to See in 2026

“Having the opportunity to be a speaker and panelist at the Regulatory Alliance Forum was an honor. More importantly, it was a lot of fun in a fantastic location, and a small enough setting to have real discussions with amazing people.”

— David Pudwill, Principal Consultant, Mr. Regulatory