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  4. Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation Public Workshop - 03/29/2021 - 03/30/2021
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Virtual

Event Title
Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation Public Workshop
March 29 - 30, 2021


Date:
March 29 - 30, 2021
Day1:
- ET
Day2:
- ET

SUMMARY

Discuss the recent drug contamination with nitrosamines.

DESCRIPTION

This public workshop is scheduled and planned as a virtual meeting. The Food and Drug Administration (FDA) is announcing a virtual public workshop entitled: Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation Workshop. This workshop will include presentations and question and answer by expert panelists.

ABOUT THE PUBLIC WORKSHOP

The workshop will include presentations on nitrosamines chemistry and toxicology and, on the finding of nitrosamines as impurities in drugs. The presentations will be followed by open discussion of questions prepared by the FDA and presented to expert panelists for deliberations over 2 days. Topics to be addressed include nitrosamines as chemicals present in the environment, in food and, more recently, detected as impurities in drugs, nitrosamine pharmacokinetics, carcinogenesis, mutagenesis, (Q)SAR, and health risk assessment and mitigation. In addition, the panelists will be asked to identify data gaps and research needs to address uncertainties in nitrosamine safety assessment and how to prevent or minimize their presence in drugs.

REGISTRATION AND CHECK-IN

Interested parties are encouraged to register early via the Eventbrite site Nitrosamine Impurities Eventbrite.

Registration is required for online attendance and will be available until 4pm on March 26, 2021.

MEETING MATERIALS

Final Agenda (PDF - 131 KB)

List of Panelists (PDF - 424 KB)

Nitrosamines as Impurities in Drugs Workshop Presentation (PDF - 1.85 MB)

Dr. Kyrtopoulos Q1 & Q3 Slides (XML - 181 KB)

Nitrosamine Workshop Report Final (PDF - 319 KB)

Please visit the Eventbrite site Nitrosamine Impurities Eventbrite for additional information.

ONLINE ATTENDANCE (WEBCAST)

This meeting will be available for online viewing, on the day of the meeting via the following Zoom links:

DAY I:

Date and time: Monday, March 29, 2021 9:00 am Eastern Daylight Time (New York, GMT-04:00)

Event address:
https://fda.zoomgov.com/j/1607725099?pwd=Y3J3bHRLeWk1ZTh2bTEzWGNKMDFQZz09

Passcode: @8hKiE

Or iPhone one-tap: :
US: +16692545252,,1607725099# or +16468287666,,1607725099#

Or Telephone:
Dial (for higher quality, dial a number based on your current location)
:
US: +1 669 254 5252 or +1 646 828 7666 or +1 669 216 1590 or +1 551 285 1373 or 833 568 8864 (Toll Free)

Webinar ID: 160 772 5099
International numbers available: https://fda.zoomgov.com/u/a5uMqU5hF

Recording Link:
https://fda.zoomgov.com/rec/share/w5RfM-zP-iBJYtLPsF37AIwzPo_maaa82yYf-aENn0posDQl3AeelWY0F9qiGC9p
Recording Passcode:
6+041BVG

DAY II:

Date and time: Tuesday, March 30, 2021 9:00 am Eastern Daylight Time (New York, GMT-04:00)

Event address:
https://fda.zoomgov.com/j/1607725099?pwd=Y3J3bHRLeWk1ZTh2bTEzWGNKMDFQZz09

Passcode: @8hKiE

Or iPhone one-tap: :
US: +16692545252,,1609885470# or +16468287666,,1609885470#

Or Telephone:
Dial (for higher quality, dial a number based on your current location)
:
US: +1 669 254 5252 or +1 646 828 7666 or +1 551 285 1373 or +1 669 216 1590 or 833 568 8864 (Toll Free)

Webinar ID: 160 988 5470
International numbers available: https://fda.zoomgov.com/u/adueZTLljH

Recording Link:
https://fda.zoomgov.com/rec/share/x8F8EY720VJJEs-T5hjmXp4uOJvDaaa823Ieq_VZxFnfaK9RhSMEVNsCx_aTyQM
Recording Passcode:
ET@6a7vR

CONTACT

If further information is needed, please contact the OND Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov


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