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

  • Wednesday, October 16, 2019
  • Friday, October 18, 2019
  • 201 N 17th st Philadelphia, PA 19103

Registration


Registration is closed

Our next workshop, which will be held in Philadelphia on October 16-18, 2019, is focused on understanding and correctly characterizing the 505(b)(2) pathway, while debunking the rampant misconceptions circulating in the pharmaceutical industry. Additionally, the agenda will look 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 is a unique workshop in which we will extend 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 will address the science, regulatory, legal, and financing components that are crucial to the successful development and launch of a 505(b)(2) product.

Join us in demystifying 505(b)(2) Development!

The Philadelphia 201
201 N 17th st
Philadelphia, PA 19103

If traveling by train, The 201 is a 4 minute walk from Suburban Station.

Agenda
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The event venue is booked at this time. Please find a list of alternative hotels that are within a few blocks of the event venue. We apologize for the inconvenience. We look forward to seeing you October 16-18th!

The Windsor Suites
1700 Benjamin Franklin Pkwy, Philadelphia, PA 19103

Embassy Suites by Hilton Philadelphia Center City
1776 Benjamin Franklin Pkwy, Philadelphia, PA 19103

Hampton Inn Philadelphia Center City-Convention Center
1776 Benjamin Franklin Pkwy, Philadelphia, PA 19103

Four Points by Sheraton Philadelphia City Center
1201 Race St, Philadelphia, PA 19107

Residence Inn by Marriott Philadelphia Center City
One E Penn Square, Philadelphia, PA 19107

DoubleTree by Hilton Hotel Philadelphia Center City

237 S Broad St, Philadelphia, PA 19107