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Ask the Experts: How to have an effective INTERACT meeting with the FDA

Post thumbnail Ask the Experts: How to have an effective INTERACT meeting with the FDA

INTERACT meeting is an informal non-binding consultation with the CBER at FDA. It allows sponsors to obtain preliminary informal consultation for innovative investigational products at an early stage of development on issues that are not yet at the pre-IND meeting phase.

Although this meeting is highly recommended by FDA, an INTERACT meeting is not an FDA requirement.

In this “Ask the Expert” session, you can ask any questions you may have with regards to this meeting, such as:
– Why request an INTERACT meeting?
– At what point in pre-clinical development should an INTERACT meeting be requested
– What does the INTERACT program involve/consist of?
– What should I expect after an INTERACT meeting is requested?

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    Teaser Ask the Experts How to have an effective INTERACT meeting with the FDA

    Featured Speakers

    Mike Day
    Michael Day, PhD
    Senior Director Regulatory Science
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    Alexandra Beumer Sassi
    Alexandra Beumer Sassi, PhD, RAC
    Senior Director, CMC
    As a Director, Chemistry, Manufacturing, and Controls (CMC) at VCLS, Alexandra (Alex) is responsible for providing CMC and regulatory consulting services to clients to help them take their…
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