Date and Time:
November 6,
8:30 am – 5:30 pm,
November 7,
8:30 am– 5:30 pm
Co-hosts: FDA and the Center for Research on Complex Generics (CRCG)
In person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop.
The purpose of this workshop is to review the current research and recommendations on methods for confirmatory testing of NDSRI formation, safety testing methods for NDSRIs and recommended acceptable intake limits for NDSRIs based on predicted carcinogenic potency and compound-specific data or read-across analysis. The workshop will also discuss strategies to mitigate the risk of NDSRIs formation. Another key focus of the workshop is to provide an update on FDA policy and guidance in assessing formulation stability, and recommendations for bioequivalence approaches when drug developers are considering reformulation.
Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products - The Center for Research on Complex Generics (CRCG)
Registration will be available soon.
5 Likes
@trust_user_a @trust_user_b @trust_user_c @trust_user_d
Registration has opened for the ’ Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products
Date and Time: November 6 & 7
Co-hosts: FDA and the Center for Research on Complex Generics (CRCG)
Several of the Nitrosamines Exchange community will be in-person presenting at this event.
The workshop’s focus is to review the current research and recommendations on confirmatory NDSRI formation, safety testing methods for NDSRIs and recommended acceptable intake limits for NDSRIs based on predicted carcinogenic potency and compound-specific data or read-across analysis. The workshop will also discuss strategies to mitigate the risk of NDSRI formation. Another key focus of the workshop is to provide updates on the guidance in assessing formulation stability and recommendations for bioequivalence approaches when drug developers are considering reformulation. The speakers and panelists will also discuss the regulatory approaches for navigating the implemented changes and share their regulatory experiences in pre- and post-approval changes in ANDA/NDA submissions and supplements illustrated with relevant case studies.
Registration page: Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products - The Center for Research on Complex Generics (CRCG)
Program includes:
- Safety & Risk Assessment Methods and Recommendations for Acceptable Intake Limit
- Risk Factors of Formation of NDSRIs and Mitigation Strategies
- Update on the Policy Guidance and Recommendation in Assessing Formulation Stability and Bioequivalence Approaches
6 Likes
Hi @Naiffer_Host ,
Thank you for sharing the registration link.
The event starts @ 6 pm IST and runs late night. Can we get the event recordings if we miss any of the presentations.
1 Like
The recordings and slides are available in the previous events. Please check the website.
I hope the recordings will also be available in the upcoming event.
3 Likes
Dear @Naiffer_Host
Is there a possibility to get the slides from this event. I am attending a different Conference at the same time and therefore can not join this event, which is a pity.
Thanks for your help
Thank you for the information. I signed up today to attend the event virtually.
