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Overview

The FDA recently released two draft guidance documents, “Development of a Shared System REMS” and “Waivers of the Single, Shared System REMS Requirement.” These guidances establish the conditions when a Single, Shared System Risk Evaluation and Mitigation Strategy (SSS REMS) is required or may be beneficial to sponsors, and how to request a waiver from a SSS REMS. While the FDA may require generic drug manufacturers to share an SSS REMS with the listed drug manufacturer in order to manage and mitigate the drug’s potential safety risks, SSS REMS are very difficult, and in some cases impossible, to achieve and can be a potential reason for delayed generic drug entry to the market.

In this 90-minute webinar, experts will discuss the impact of these guidances on both the medical products community and on public health and access. The webinar will also cover issues companies face in developing an SSS REMS, and the impact the CREATES Act, if passed by Congress, would have on addressing REMS concerns.

Speakers

Elaine Lippmann, Senior Regulatory Counsel, FDA – CDER
Lynn Mehler, Partner, Hogan Lovells US LLP
Rachel Turow, Executive Counsel – Regulatory Law, TEVA Pharmaceuticals USA, Inc.
Moderated by Frederick Ball, Partner, Duane Morris LLP

Register

Webinar

$99
  • +$100 for non-members

Webinar & Recording

$149
  • +$100 for non-members
Register Now

To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.

2019-04-16T10:56:19-04:00