1. Animal Strategy (1 point)
Based on the simulated meeting for forming an animal strategy in this week’s
Lecture 4 slides where you provided five important advice to the Clinical
Research team, they did not trust you as they thought you were being too
conservative about how the animal testing should be conducted under GLP
conditions. They think you are making this up and they are upset because they
have to spend $20,000 USD more and the animal testing will take 2-3 months
longer than that of a non-GLP animal study.
Instead of ignoring them or asking them to see your RA manager for further
discussion, you have the option to nicely and gently guide them to FDA’s Code of
Federal Regulations (CFR) for GLP testing.
Hint – similarly to your Week 4 reading assignment, go to www.fda.gov and click
on “Medical Devices” and click on “Device Advice” and in the search box, type
“Good Laboratory Practices.”
What is the 21 CFR “XX” code for GLP testing?
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2. Clinical Strategy (5 points)
Based on the simulated meeting for forming a human clinical strategy in this
week’s Lecture 4 slides where you also provided five important advice to the
Clinical Research team, they have now earned your trust and respect you wholeheartedly
as an experienced RA professional.
They need your guidance for forming the inclusion and exclusion criteria for this
Atrial Fibrillation clinical study because they have no idea until they can get a
hold of another competitors’ clinical study protocol.
They also don’t know if FDA would accept a 3 month follow up on the patients
for a primary effectiveness endpoint. They also don’t know if FDA requires a
secondary long-term follow-up on the enrolled patients.
Hint – similarly to your Week 4 reading assignment, go to www.fda.gov and click
on “Medical Devices” and click on “Device Advice” and click on “Guidance
Documents” and in the search box, type “Catheter Ablation Atrial Fibrillation”
(please watch out and do not use the FDA guidance on using surgical ablation
devices to treat AFib).
a. Per recommendations from FDA when designing an AFib clinical study,
provide at least 2 inclusion criteria and 1 exclusion criteria for patient
selection.
b. What is FDA’s position for how long the “primary effectiveness endpoint”
should be for measuring how many AFib recurrences have occurred in the
enrolled patients after receiving treatment for clinical success?
c. What is FDA’s position for how long the secondary “long-term” follow-up
should be for studying adverse effects to the pulmonary veins, which supply
oxygenated blood from the lungs to the heart, in the enrolled patients?
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3. Global Regulatory Strategy (20 points)
Based on the simulated meeting for preparing a Global Regulatory Strategy in this
week’s Lecture 4 slides, please complete the regulatory pathways for each country.
The company decided to use BSi (British Standards of Institute) as the Notified Body.
Hint – please feel free to refer back to Week 1 lecture slides for the names and branches
and submission types and review times.
Global Regulatory Affairs Strategy for
AFib Ablation Catheter
No. Country Name of
Agency
Name of
Branch
Device
Class
Submission Type Review Time
1. US
2. Europe —
3. Canada
4. Japan
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4. Pre-Sub Presentation to FDA (24 points)
Please prepare a 10 to 12 page presentation in MS PowerPoint for your Pre-Sub
packet to FDA on your proposed AFib Ablation Catheter.
There will only be 1 hour for this Pre-Sub meeting with FDA whether it is done
face-to-face or via teleconference call. The presentation should be no more than
10 to 12 slides as you should only present for 20-30 minutes and leave enough
room for the rest of the time or in-between the presentation slides for questions
and answers.
? Slide 1 should contain the title of your Pre-Sub meeting, the name of the
subject catheter, the submission date and your name and title (author).
? Slide 2 should contain the list of proposed attendees from your company. You
should also indicate if this meeting is face-to-face or via teleconference call.
Also, you have the option to submit three proposed dates and times for this
meeting with FDA as long as it is 60 days from this assignment’s due date.
Otherwise, you have the option to indicate meeting date and time “TBD” (To
be determined).
? Slide 3 should contain the list of objectives for the meeting.
? Slide 4 should contain a list of specifications for the catheter.
? Slide 5 should contain a representative picture of the catheter. Please feel free
to cut and paste pictures of the catheter from previous lecture slides.
? Slide 6 should contain a list of proposed testing as identified from the risk
analysis, along with the number of sample size for each test.
? Slide 7 should contain the proposed in vivo animal strategy.
? Slide 8 and 9 (if needed) should contain the proposed human clinical strategy.
For the items that Clinical Research department is uncertain about based on
Week 4 meeting simulation in the lecture slides, management has asked you
to incorporate and present whatever FDA recommendations you have found
on these matters, for the sake of time.
? Slide 10 should invite any questions FDA may have at the end of the meeting
or you may have for FDA.
? Slide 11 should thank FDA for their time.
Please submit Question 4 in MS PowerPoint slide presentation.