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GW_2018_community_workshop_6_12_18

Please join us in Washington, D.C. on July 12, 2018 to share your voice with the Food and Drug Administration (FDA) and pharmaceutical industry! The purpose of this workshop is to provide targeted feedback and information from the ALS Community to further inform the FDA’s Draft Guidance on ALS Drug Development. All ALS stakeholders are invited to attend. The event will be live streamed and recorded for those who cannot join us in person.

Workshop Overview

People with ALS, advocates, academics, clinicians, and industry panelists will participate in moderated discussions that will explore key topics in ALS drug development such as:

  • Benefit risk considerations

  • Study design, natural history, recruitment, and retention

  • Outcome measures, endpoints, and accelerated approval considerations

Audience and online participation will be encouraged.

The ALS Community workshop will be live streamed and recorded. Watch the live stream on this page or tune into our Facebook or YouTube pages.

If you plan on attending the (online) live stream event, please register here: https://thealsassociation.formstack.com/forms/signup

General Procedure

The ALS Association will accept questions and comments from in-person and online Workshop attendees. We encourage online attendees to submit questions in advance and during the live event by sending email messages to our designated Workshop email inbox: ALSFDAworkshop@alsa-national.org.

The ALS Association will review all questions and then elevate questions to the Workshop moderator.

While we may not be able to answer every question submitted, our priority is to make sure every voice is heard. You can ensure your voice is heard by participating in the conversation on social media using the hashtag #ALSFDA.

Two weeks after the Workshop, we will compile any additional questions and comments from the ALS community and send them all to FDA leadership.

Question Submission

The ALS Association invites attendees to submit questions and comments by email prior to and during the Workshop. Please note that emailed questions will take top priority.

  • Before and during the Workshop, ALS community members are encouraged to email ALSFDAworkshop@alsa-national.org with their questions.

  • We will not be able to address every question during the Workshop, but will respond to all ALS community members’ emails in the coming weeks.