2019 Fall Scientific Workshop

Demystifying 505(b)(2) Development: Navigating the Scientific, Regulatory, Legal, and Business Complexities

Oct. 16-18 The Philadelphia 201
201 N 17th St.
Philadelphia, PA 19103

Our Fall workshop, which was held in Philadelphia on October 16-18, 2019, focused on understanding and correctly characterizing the 505(b)(2) pathway, while debunking the rampant misconceptions circulating in the pharmaceutical industry. Additionally, the agenda looked at how value-added medicines created through the 505(b)(2) pathway may, with focused upfront planning, satisfy other regulatory authorities, like EMA, allowing them to be parlayed into global marketing opportunities. For SAAMnow, this was a unique workshop in which we extended our reach beyond just science by collaborating with a complimentary non-profit organization, The 505(b)(2) Platform with a synergistic remit. Our speakers, panelists, moderators and invited FDA addressed the science, regulatory, legal, and financing components that are crucial to the successful development and launch of a 505(b)(2) product.

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Speakers

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