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Annual Public Meeting Zoom - Shared screen with speaker view
joel.finkle@beigene.com
01:23:22
Is there a plan for the Cloud ESG to become a shared platform where sponsors can update individual files (versions retained of course), to make them available to the agency?
Sandeep Reddy Kondam@Otsuka Pharmaceuticals
01:29:52
Peter , we are not able to hear you.
o
01:29:53
We can't anymore
McKenzie Lambert
01:30:06
can now
o
01:30:08
We can hear now
prasanna.murugesan@astrazeneca.com
01:46:04
Could you please comment on the type of cloud service that will be used in this upgrade? Will it be on-premise cloud account or dedicated private cloud account?
OAlfieri
01:46:17
Comment: 2019 AWS Keys and the Capital One Breach: On March 22 and 2019, the attached gained access to a set of AWS access keys by accessing the AWS EC2 metadata service via an SSRF vulnerability and gained access to Capital One Financial Corporation personal information relating to people who had applied for its credit card products and to Capital One credit card customers.Q1: How can FDA ensure all data provided by Pharma is secured?Q2: What is the FDA strategies to mitigate AWS risks to ensure common AWS configuration mistakes that could lead to security vulnerabilities?
wfriggle
01:47:02
how is the FDA preparing for a potential “shared access scenarios” (e.g., real-time or near real-time clinical trial data)?
Badri Varadarajan
01:47:29
Could you please let us know if there will be any changes that are required for existing test/production accounts registered with ESG now
smaliekal
01:48:35
Will the power user account be available to a sponsor that has outsourced publishing functionality to a third part vendor for submission through ESG?
CALLAHANL
01:51:50
Faint sound
Jen Anklesaria
01:52:13
good on my end
Santha Ramakrishnan
02:00:35
Will the deck and the recording be shared?
Ron Fitzmartin (FDA)
02:02:25
Yes. They will be posted to the FDA PDUFA VI webpage on IT
Santha Ramakrishnan
02:04:01
Thanks Ron
Jean-Gonzague Fontaine
02:10:06
Using detailed active ingredient role may support the PhPID calculation, algorithm being able to identify if the strength to be used shall be the substance or reference substance strength to be used in the calculation. We have a section on ingredient role in the EUIG v2, chapter 8, where we provided examples.
Jean-Gonzague Fontaine
02:10:53
The ACTI variations are not mention per se, but understandable from the diagram.
Hans van Bruggen (Qdossier)
02:26:56
Could we also consider a pilot with tabular approaches where a table title contains the context (e.g. product, dose form and strength) and the table contains the content as tagged information (e.g. color, shape, filler, active). This does not require a schema at all
Ron Fitzmartin (FDA)
02:32:23
on break. RECONVENE AT 11 AM EST
Ron Fitzmartin (FDA)
02:48:25
Update: IDMP 11-12 ET, Break 12-1, and start IND Safety at 1 ET
Vada A. Perkins
02:51:11
Follow up regarding Active ingredient class codes noted in ISO IDMP. ACTIB, ACTIM, and ACTIR are already included/implemented in the US as part of FDA HL7 SPL implementation. We, Industry, have to submit the basis of strength for the relevant HL7 SPL submissions.
Santha Ramakrishnan
03:15:15
How is this index of substances different from CAS which has spent so much time in development?
joel.finkle@beigene.com
03:34:12
Is there any plan to adopt more of IDMP beyond the PhPID and of course the NDC at FDA? Do you see it evolving toward something similar to EMA's implementation, where it serves as a big part of the application form?
joel.finkle@beigene.com
03:34:40
(When I say IDMP above I mean ISO 11615)
Santha Ramakrishnan
03:34:41
thanks lawrence
Santha Ramakrishnan
03:39:58
That would be a good industry effort !/ global ID
Vada A. Perkins
03:41:31
Would/could you utilize FD&C Act 745A to mandate IDMP or other relevant data standards? CDISC pathway?
Ankit
05:20:55
Is there plan/roadmap on the IDMP IDs (e.g. SubID, MPID, PhPID…..etc.) and future IND report synergies? Specially as FDA already compliant with ISO standards for some of these IDs.
paisley
05:50:35
In 3.3, the DUNS number is not required but has a medium error if missing. Will this change when 3.3 is required next year so validation reports can be clean?
paisley
05:51:08
Also, what email should be used for questions regarding eCTD 4.0?
Helle Gawrylewski
05:54:05
could you elaborate on concept of enhanced life-cycle control?
paisley
06:07:50
Sorry but I was not able to hear you at the end of the discussion about the email to use for contacting the FDA with general questions. Please repeat your answer.
Virginia.Hussong@fda.hhs.gov
06:08:40
general esubmission/eCTD questions for FDA should go to ESUB@fda.hhs.gov
paisley
06:09:28
Including questions regarding 4.0?
Virginia.Hussong@fda.hhs.gov
06:10:05
Specific questions for CBER should go to CBER ESUBPREP <ESUBPREP@fda.hhs.gov>
Virginia.Hussong@fda.hhs.gov
06:10:56
We don't have a separate email for eCTD4 - you can use the standard email addresses.
paisley
06:11:52
OK thank you
paisley
06:43:16
Will the slides be available with the recording after the meeting?
Graham.Horst@fda.hhs.gov
06:45:07
Yes. They will be posted to the FDA PDUFA VI webpage on IT
paisley
06:46:49
OK thank you. Will an email be sent when they are available with a URL to the page?
Ron Fitzmartin (FDA)
06:50:41
An email will not be sent. Please check this website. Should be posted no later than end of month. https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vi-information-technology-goals-and-progress
Cathy Roy
06:55:36
Is the TSVALNF variable/column needed IF the STSTDTC is populated
Cathy Roy
07:00:16
That question for TSVALNF is specific to Nonclinical - do we even need the variable present
Audrey Walker
07:03:18
if STSTDTC is populated do we even need to include the TSVALNF column/variable
Bill McJames
07:03:40
Are multiple study IDs allowed for SPREFID?
paisley
07:04:16
What would the delimiter be?
paisley
07:05:01
if multiple IDs are entered
Kathryn Brown
07:05:38
Did Ethan say that we need to include TSVALNF even if STSTDTC is populated?
Sandeep Reddy Kondam@Otsuka Pharmaceuticals
07:06:38
Thank you very much and have a good day everyone!!
Beth Volkmar
07:06:45
thank you