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Printable Handouts
Navigable Slide Index
- Introduction
- Disclaimer
- Outline
- Before the IND: a pre-IND meeting
- IND Regulations: 21 CFR 312
- Key clinical development milestones
- Phase 1 studies (21 CFR 312.21(a))
- Phase 1: clinical hold criteria
- Phase 2 studies (21 CFR 312.21(b))
- Phase 2 clinical hold criteria 21 CFR 312.42(2)
- End of Phase 2 meeting
- Phase 3 studies (21 CFR 312.21(c))
- Phase 3 studies (21 CFR 312.21(c)) - size
- Safety standard for vaccine licensure
- Assessing vaccine safety: definitions
- Assessing vaccine safety: definitions part 2
- Assessing vaccine safety: reporting requirements
- Assessing vaccine safety: IND safety reporting
- Vaccine safety: additional considerations
- Effectiveness standard for vaccine licensure
Topics Covered
- Investigational New Drug (IND) regulations
- Key clinical development milestones
- Safety and efficacy concepts: a regulator’s perspective
Links
Series:
Categories:
Therapeutic Areas:
Talk Citation
Schrager, L.K. (2015, November 30). Regulatory considerations for vaccine development: talk 2 – clinical regulatory considerations 1 [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 22, 2024, from https://doi.org/10.69645/EYTL4803.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Lewis K. Schrager has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Regulatory considerations for vaccine development: talk 2 – clinical regulatory considerations 1
Published on November 30, 2015
33 min
Other Talks in the Series: Vaccines
Transcript
Please wait while the transcript is being prepared...
0:00
My name is Lewis Schrager,
I'm Vice President
of Scientific Affairs for Aeras.
I will be discussing
Regulatory Considerations
for Vaccine Development.
This is talk 2 of a series
of vaccine development talks.
Talk 1 was given
by Dr. Norman Baylor,
with a concentration
on chemical manufacturing
and control issues, as well as
pre-clinical regulatory issues.
My talk, talk 2, will focus
on clinical regulatory
considerations.
0:31
I need to let you know
that the perspectives
that I'll provide in this
presentation are my own,
and are not intended
to represent
those of the US Food
and Drug Administration.
I do not work for the US
Food and Drug Administration,
but in years past I had,
I want to make
that perfectly clear.
0:51
The outline of the talk,
in general, will be as follows.
We'll start off by talking about
investigational
new drug regulations
or IND regulations.
Then we'll talk about
the three pathways
that are available
to attain biological licenses,
they are called
biological license application
or BLA pathways:
the traditional pathway,
the accelerated approval
pathway, and the animal rule.
We'll talk about programs
that could accelerate
the clinical testing,
that is, the IND phase
and review the BLA phase
of these processes.
And these accelerated
clinical testing
and review processes
are fast track designation,
breakthrough designation,
and priority review.
We'll touch upon
the package insert,
just to familiarize
it with yourself,
given that it's the critical
regulatory work product
of vaccine development.
We'll focus on safety
and efficacy concepts
as vaccines are tested,
and give you the regulator's
perspective on these issues.
And then we'll touch on
a couple of other issues
that are important
when considering
vaccine regulation, one
being adaptive trial design,
another being
developing vaccines
for global infectious diseases,
and some of the regulatory
incentives that entail.
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