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FDA-University of Maryland CERSI Pharmacokinetic Evaluation in Pregnancy Workshop - Shared screen with speaker view
Devante Stephenson
01:01:16
Hey Daphne, the recording has started.
Ahizechukwu Eke
01:13:32
I cannot start my camera - States that "you cannot start your video because the host has stopped it". Can anyone help?
AV Support | Gretchen Carter
01:14:01
Yes I stopped it because it popped up during the presentation
Ahizechukwu Eke
01:14:22
Oh I see. Thanks.
Daphne Guinn
01:24:18
Thanks for joining. Please provide any questions for the presenters in the Q&A box.
Daphne Guinn
01:30:20
Today's agenda can be found here: https://www.fda.gov/drugs/news-events-human-drugs/pharmacokinetic-evaluation-pregnancy-virtual-public-workshop-05162022
Ahizechukwu Eke
01:40:35
I am presenting next - I hope my video can be enabled
AV Support | Gretchen Carter
01:41:32
You will receive a notification to start your video
Ahizechukwu Eke
01:41:42
Perfect
Daphne Guinn
02:20:07
Hi Presenters! Please feel free to answer questions that are coming in through the Q&A. We may not get to all questions during the Q&A session.
Daphne Guinn
02:39:36
Thanks for joining. Please provide any questions for the presenters in the Q&A box. Please also indicate which speaker you would like to address your question.
Devante Stephenson
02:42:18
We would have to interrupt him
Devante Stephenson
03:16:17
Apologies.
Daphne Guinn
03:33:05
Workshop Materials can be found on the following webpages. This will include the slides & recording following the workshop.
Daphne Guinn
03:33:19
https://cersi.umd.edu/event/17326/fdam-cersi-workshop-pharmacokinetic-evaluation-in-pregnancy
Daphne Guinn
03:33:25
https://go.usa.gov/xu2MX.
Daphne Guinn
04:45:19
Please provide any questions/comments for the panelists in the Q&A box.
Aaron Pawlyk
04:46:17
NASEM workshop - https://www.nationalacademies.org/our-work/inclusion-of-pregnant-and-lactating-persons-in-clinical-trials-a-workshop
Aaron Pawlyk
04:46:35
MPRINT Hubhttps://mprint.org/index.htmlhttps://mprint.org/research/research-support/index.html
Aaron Pawlyk
04:47:04
R01 and R21 opportunities:https://grants.nih.gov/grants/guide/pa-files/PAR-20-300.htmlhttps://grants.nih.gov/grants/guide/pa-files/PAR-20-299.html
Aaron Pawlyk
04:47:35
Renewal RFAs for the Maternal Fetal Medicine Units Network:MFMU DCC: https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-23-017.htmlMFMU sites: https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-23-016.html
Aaron Pawlyk
04:47:55
NICHD clinical trial infrastructure:https://www.nichd.nih.gov/about/meetings/2019/110119
Martina Penazzato (WHO-HQ)
05:19:50
On Prioritization: For HIV the WHO-convened CADO process helps to prioritize R&D in the context of the public health approach but such a process doesn't exist for other diseases. Expanding that practice might help all stakeholders to align around needs and priorities but this has not been discussed internally yet. If regulators and industry found this process of interest we could take this back and discuss with appropriate colleagues and explore what is possible in other disease areas.
Aaron Pawlyk
05:47:44
The NIH's IMPROVE initiative has a large focus on inclusion for underrepresented populations for pregnancy outcomes - https://www.nih.gov/research-training/medical-research-initiatives/improve-initiative