FDA/HESI Research Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs

FDA/HESI Research Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs

Day1: Wed, May 31 9:00 AM - 5:00 PM ET
Day2: Thu, Jun 1 8:30 AM - 3:45 PM ET

The goal of the workshop is to engage stakeholders with expertise in the assessment of nitrosamines (NA), including Nitrosamine Drug Substance-related Impurities (NDSRI) in order to achieve the following:

  • Provide a high-level synthesis of key areas/objectives of current research on NA detection and evaluation;
  • Identify short-term (1-2 years) research needs that can address data gaps required to improve nitrosamine (NA) risk assessments;
  • Identify mid-term (3-5 years) and long-term (5+ years) research needs to improve nitrosamine (NA) risk assessments;
  • Discuss potential opportunities and forums to realize the identified research gaps (e.g., FDA-initiated Public Private Partnership, existing or new consortial efforts, grants, private sector research efforts, etc.)
  • Develop a NA-research roadmap in support of an uninterrupted drug supply that is also protective of public health.

Registration free: https://register.gotowebinar.com/register/1148664626175340383

Agenda attached
Updated-FDA-HESI-Research-Roadmap-Planning-on-Hazard-and-Risk-Assessment-of-Nitrosamine-Impurities-in-Drugs.pdf (192.0 KB)

Speakers include: @kpcross @jbercu @David among others

Important topics will be discussed:

  • Structure-activity relationships (SAR), in silico / computational models, quantum mechanics, mode of action (MOA) studies to characterize risk, DNA repair mechanisms, in vitro to in vivo extrapolation and dose-response modelling of in vivo mutagenicity studies.
  • Ames testing, other in vitro mutation tests, in vivo studies, DNA adduct assessment, and metabolism (in silico, in vitro, in vivo)

@trust_user_a @trust_user_b @trust_user_c You do NOT want to miss this event!


Thanks for sharing! I’m sharing this and other events that are posted in the exchange with my colleagues.

1 Like

Thanks for sharing!
I tried to sign up, but the field “Country/Region” is not enabled for filling or choosing options. Someone else had this problem too?


Thank you very much for the invitation, I’ll pass this through my organization.

1 Like

Estimado colegas @LATAM_Community este es un evento que no se pueden perder!

I also had this problem.

Hello, are you clicking the link @Naiffer_Host send? or the translation? I clicked at the direct message link and worked for me. I´ll send it to see if it helps:
-FDA/HESI Workshop: Building A Research Roadmap for Hazard and Risk Assessment of Nitrosamine Impurities in Drugs

I will remind you of these great sessions.


Hesi/FDA meeting kicked off today, excitement is building up among the participants. All the eyes of the industry are focus on the outcome of this meeting…

Dr. Robert Heflich - Genetic and Molecular Toxicology - FDA

Dr. Maik Schuler - Pfizer

Dr. Kevin Cross - Leadscope

Dr. Andreas Czich - Sanofi/Hesi


Risk Characterization

Dr. Joel Bercu - Gilead

Dr. David Ponting - Lhasa

Dr. Naomi Kruhlak - FDA



Dear Naiffer

is it above decision tree is acceptable or approved by USFDA or any health authority??

No, it was a proposed workflow by stakeholder to the representatives seating at the FDA/HESI meeting. Once again, this is not official


That was a fantastic workshop. I couldn’t understand the whole session because it was too specialized. However, I found that toxicological discussions such as the Ames study, in vivo studies, and QSAR for NDSRIs were still ongoing. It seems to take more than one year to decide how to deal with NDSRIs.

Slide from Dr. Maik Schuler’s presentation

Slide from Group C in breakout session 2

And I want to ask you, experts, what pharmaceutical companies are doing for “call for review” in the EU, USA, and other areas. The deadline for Step 2 came in the EU, and Step 2 will finish at the beginning of October in the USA. But as far as I know, the AI for many NDSRIs is still unclear. In other words, the regulation goes faster than the investigation. What can we do in front of those unclear AIs? Are Interim AIs being established? Are the amounts of NDSRIs controlled to meet these interim AIs? I want to hear your opinion, guys.


@Yosukemino a fantastic meeting indeed. In my honest (non-texicology) opinion, the Nitrosamine safety discussion is very raw. From what I gather in the workshop, several options have been presented to the agencies for consideration so not every NDSRIs has to undergo transgenic testing. I believe the list of tests and assays presented were quite extensive and relevant in all the debate about the true potency of NDSRIs.
The recent FDA open for comments and the workshops taking place only weeks apart from each other can be perceived as the agency gathering all the information and feedback to make short and long-term decisions.
I would love to hear other opinions and perceptions from the meeting.


@lucas10mauriz wrote a fantastic summary of his thought and reactions to the meeting

Thanks Lucas!


Good question infact @Yosukemino - I am in opinion, there could be an extension keeping in mind the pragmatic way to deal with nitrosamines.
As discussed FDA/HESI workshop triaging the nitrosamines/NDSRI’s will help to meet an extent of agency goal of Step-2.


Would it be possible to get the recordings for the ones who missed this excellent workshop?
Thank you for answering!

1 Like

Dear @Naiffer_Host , the workshop was fantastic! Unfortunately, I couldn’t be there in person to witness all the discussions. However, the ones I could remotely attend were incredibly enriching, which is why I’ve decided to provide a summary. Thank you and USP for the opportunity and the space to share our knowledge.


A lot of people have been asking me if the recording of the meeting will be available. Most likely, we will have access to the official proceedings soon. Keep an eye out for them!

There’s possibly more to come out of the breakout groups that weren’t broadcast due to time restrictions.