FDAXapproved

LIVE WEBINAR: Making American Guidance Understandable Again: How FDA’s new enthusiasm for harmonization brings opportunity for international firms. 17 January

January 17, 2019

Details

FDA has announced broad reaching initiatives to update the 510(k) program and leverage international practices and requirements. This brings real opportunities for international firms to make much greater use of their non-US regulatory data to gain FDA approvals.

Join T.J. Thiel and Jean Nicolas Boudaud to provide guidance in navigating the FDA’s submission process uses your company’s international regulatory work. T.J. and Jean will discuss the numerous pathways for FDA approval as well as how these relate to the international (including TGA, Health Canada and EU) regulatory activities. This webinar will help understand the current synergies but also focus on the opportunities for harmonization.

11am Thursday January 17: AUSTRALIAN EASTERN
12am London BST
1am CEDT

Wednesday January 16: USA 4pm PACIFIC / 7pm EDT


If you can’t attend the live session, register to receive the recording to view on demand after.

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Date and Time

January 17, 2019
11:00 am - 12:00 pm

Location

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