ACI Hatch-Waxman and BPCIA Virtual Proficiency Series

American Conference Institute (ACI) will be holding its Hatch-Waxman and BPCIA Virtual Proficiency Series, a 3-week primer on IP basics and regulatory fundamentals on small molecule and biologic drugs and their generic and biosimilar equivalents, from October 5-21, 2021. In Week One, meeting on October 5th and 7th, the regulatory framework will be discussed, including: • The interplay between the PTO and FDA • Pre-commercialization concerns • Links between the FDA approval process and the patent process • The Orange Book Week Two, meeting on October 12th and 14th, will cover the Hatch-Waxman and BPCIA framework, including: • The Hatch-Waxman…

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