NAMs are innovative testing methods and strategies used to assess the safety, efficacy, and quality of drugs and biologics. One of their primary aims of NAMs is to support the replacement, reduction and refinement (‘3Rs’ principles) of animal use in biotechnology. International regulators have recently promoted the development and adoption of NAMs as part of a broader strategy to modernize drug development and improve adoption of 3Rs principles.
Join ASPHALION expert Chris Mann for a practical webinar that will give some regulatory context on NAMs as well as key concepts to keep in mind.
In this webinar we discuss and answer the following questions:
- What are NAMs and are they different from novel methodologies?
- How are NAMs regulated and how they relate to other product types (medicinal products and medical devices)?
- What pathways and designations are available for NAM developers?
- What are some key scientific, technical and regulatory requirements for NAM developers.
Register here for the webinar: https://bit.ly/3TEOHC8
If you have any questions, please contact us at [email protected]
