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Day 1 - NEW FDA, WHO THIS? WHERE ARE WE THANKS TO THE REORGANIZATIONS AND COVID? - ERIKO YOSHIMARU

Day 1 - RICHER INPUT RICHER INVESTMENT: TRAINING THE NEXT GENERATION OF REG EXPERTS - JIM KLEINEDLER

Day 1 - START-UP FOCUS: BUILDING A REGULATORY STRATEGY INTO YOUR BUSINESS PLAN (OR, HOW TO AVOID INVESTOR PANIC) - CAROLINE RHIM & LAURA GILMOUR

Day 1 - IS YOUR DE NOVO A DE NO-GO? TIPS TO IMPROVE YOUR BENEFIT/RISK PROFILE - ALLISON KUMAR & ALLISON KOMIYAMA

Day 1 - HOW RA+MARKETING CAN LEARN TO LOVE EACH OTHER: THE DIFFERENCE BETWEEN INDICATIONS FOR USE, INTENDED USE, SUBSTANTIATED CLAIMS, AND IMPLIED CLAIMS - STAYCE BECK

Day 1 - PEN PALS: MAKING THE MOST OF WRITTEN COMMUNICATION WITH FDA - SARAH LEISMER

Day 1 - PRINTING...NOW IN 3D - LAURA GILMOUR

Day 2 - SO YOU GOT AN EUA...NOW WHAT? TAKING YOUR THROUGH THE PREMARKET PROCESS - MICHAEL NILO

Day 2 - APPEALS, ALLEGATIONS AND LB FLAGS: HOW TO THROW A REGULATORY TANTRUM - ALLISON KUMAR

Day 2 - SMART DEVICES - STEPHEN WEBER

Day 2 - COMPUTERS AREN'T PILLS: WHY FDA NEEDS A NEW REGULATORY MODEL OF CYBERSECURITY - SETH CARMODY

Day 2 - WHAT'S WUT (WELL-UNDERSTOOD TECHNOLOGY)? USING FDA'S SAFETY & PERFORMANCE - BASED PATHWAY TO SUBMIT THAT 510(K) - ALEXIA HARALAMBOUS

Day 2 - A STEP INSIDE THE REAL WORLD: REAL-WORLD EVIDENCE STRATEGIES IN FDA DEVICE APPLICATIONS - STEPHEN WEBER

Day 2 - PMAS AND HOW TO BE A HIGH CLASS (III) - CAROLINE RHIM & SARAH LEISMER

Day 3 - IMPACT OF COVID-19 AND HOW IVD MANUFACTURERS CAN COPE - JOSHUA LEVIN

Day 3 - SO YOU WANT TO MARKET A HOME USE DEVICE? - DAVID PUDWILL

Day 3 - USE OF NEW APPROACH METHODS FOR BIOCOMPATIBILITY ASSESSMENT - RON BROWN

Day 3 - WHAT THE HECK IS THE PAYOR TASK FORCE? A BRIEF RUNDOWN OF HOW TO BEST USE THE PROGRAM - KEVIN GO

Day 3 - PRE-SUB PROCESS IN 2021 + HOW TO KEEP FDA FROM CHECKING EMAIL DURING YOUR TELECONFERENCE CALL - JEMIN DEDANIA

Day 3 - NAVIGATING BREAKTHROUGH AND STEP ENTRANCE REQUESTS - DULCIANA CHAN