Schedule

Agenda is below! A printable version will be available the week of the conference. Sessions will include formal speaker presentations, case studies, and panel discussions. Breaks include coffee & light snacks, and lunch will be provided all three days (dinner is not provided). Please also join us for a reception event with drinks and hors d’oeuvres on the first night.

August 16

Monday

7:00 - 8:00am: Check-in

8:00 - 8:30am: Welcome address (Komiyama)

8:30 - 9:15AM: New FDA, who dis? - Where are we thanks to the reorg and thanks to Covid? (Yoshimaru)

9:15 - 10:00am: Richer Input, richer Investment; Training the next generation of regulatory experts (Kleinedler)

10:00 - 10:15am: Break

10:15 - 11:30am Start-Up Focus - Building a regulatory strategy into your business plan (or, how to avoid investor panic) (Rhim & Gilmour)

11:30 - 12:00pm: Is your De Novo a De No-Go? Tips to improve your benefit/risk profile (Kumar & Komiyama)

12:00 - 1:30pm

Networking Lunch

1:30 - 2:15PM: The difference between indications for use, intended use, substantiated claims and implied claims - How RA and Marketing can learn to love each other (Beck)

2:15 - 3:00pm: Pen Pals: Making the most of written communication with FDA (Leismer)

3:00 - 3:15pm: Break

3:15 - 3:45pm: Printing…now in 3D! (gilmour)

3:45 - 4:30pm: Ask me anything - How to "start-up" your relationship with FDA and not wear out your welcome (all monday speakers)

5:00 - 6:30pm:

Networking & Social Event

August 17

Tuesday

8:00 - 8:15am: Check-in

8:15 - 8:30am: Recap of Day #1, Reg Chats

8:30 - 9:15am: So you got an EUA...now what? Taking your technology through the premarket process (NILo)

9:15 - 10:00am: How to throw a regulatory tantrum: Appeals, Allegations, and LB flags (Kumar)

10:00 - 10:15am: BREAK

10:15 - 11:00am: Living in a Digital World (Hanafi)

11:00 - 12:00pm: Computers aren't pills: why fda needs a new regulatory model for cybersecurity (Carmody)

12:00 - 1:30pm:

Networking Lunch

1:30 - 2:15pm: What's WUT (Well Understood Technology)? Using FDA’s Safety & Performance Based Pathway to submit that 510(k) (Haralambous)

2:15 - 3:00pm: A Step Inside the Real World - Real World Evidence Strategies in FDA Device Applications (Weber)

3:00 - 3:15pm: BREAK

3:15 - 3:45pm: PMAs and how to be High Class (III) (Rhim & Leismer)

3:45 - 4:30pm: Ask Me Anything - Taking your relationship with FDA to the next level (ALL TUESDAY SPEAKERS)

August 18

Wednesday

8:00 - 8:15am: Check-in

8:15 - 8:30am: Recap of Day #2, Reg Chats

8:30 - 9:15am: The impact of COVID-19 on how IVD manufacturers (both COVID and non-COVID) can cope (LEVIN)

9:15 - 10:00am: So you want to market a home use device? (Pudwill)

10:00 - 10:15am: BREAK

10:15 - 11:00am: Strategies to Avoid FDA Deficiencies on Your Toxicological Risk Assessment (Brown)

11:00 - 11:45am: Biocomp? More like bio-WHOMP! Biocompatibility for Beginners (Katzenmeyer-Pleuss)

11:45am - 12:00pm: The future of Biocompatibility and Toxicological Risk Assessments (Brown & Katzenmeyer-Pleuss)

12:00 - 1:30pm:

Networking Lunch

1:30 - 2:15pm: What the heck is the FDA payor task force and how to best use the program (Go)

2:15 - 3:00pm: The pre-sub process in 2021, and how to keep FDA from just checking emails during a teleconference call (Dedania)

3:00 - 3:15pm: break

3:15 - 4:00pm: Navigating Breakthrough and STeP Entrance Requests (Chan)

4:00 - 4:30pm: Ask me anything - Breaking up with FDA is hard to do (all Wednesday speakers)

4:30pm: Wrap up of conference & Farewell!