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  1. Courses
  2. Roadmapping the Clinical an...

Roadmapping the Clinical and Regulatory Paths of Subcutaneous Products and Technologies



In this virtual workshop, industry, academic, and regulatory experts will share foundational knowledge and critical information of subcutaneous (SC) delivered products, including current regulatory strategies and future directions of SC delivery and products, with specific emphasis on clinical development and regulatory paths. You will leave this event with an understanding of the state of the art/field and how to roadmap your programs moving forward in this ever-evolving landscape.

Learning Objectives:

  • Learn which formulations and technologies exist to facilitate SC delivery
  • Learn how to develop evidence packages for regulatory review
  • Determine which regulatory paths are most appropriate to gain regulatory approval
Programming Committee:
Tyler DiStefano, Ph.D., Charles River Associates
Nicholas Wechter, MS, Charles River Associates
Tina Morris, Ph.D., AAPS
David Cipolla, Ph.D., Insmed

Register for Full Conference or a Single Session
Attendees may purchase the entire workshop series or an individual session(s).
To purchase the full series, select “Add to Cart button” below.
To add a single session, select the video link below and add that individual video to the shopping cart.
All registrants will have access to the session slides and recordings post-event.

Group Registration – Available Until February 8
Bring four or more paid full conference attendees from the same company and receive a 15% discount per full conference registration. This offer cannot be used with other discounted offers (e.g. speaker rate, complimentary sponsor passes, student rates, etc.). Please email meetings@aaps.org for a discount code. The deadline to redeem the discount code is February 8, 2023. If a group does not meet the minimum requirement, AAPS reserves the right to alter the group’s registration fee.

Cancellation Policy
Cancellations must be submitted to AAPS in writing to membership@aaps.org no later than February 8, 2023. Registrations for cancellations received after February 8, 2023, will not be refunded.

AAPS will refund registration fees minus an administrative fee of $50 for members/non-members or $25 for students for cancellations received before February 8, 2023.
In the rare event that AAPS must cancel due to circumstances beyond our control, AAPS will make every effort to notify attendees as quickly as possible. Attendees will be given the opportunity to either transfer to another virtual event or obtain a full refund.
No refunds will be given for “no shows” or for attendee technology problems. It is the responsibility of the attendee to test their computer setup before the start of the virtual event. If a technical failure at the attendee’s home or workplace prevents access to the live event, the attendee is not eligible for a refund. If the technical problem is due to AAPS’ error, AAPS will issue a refund.

$115.00 - $475.00
Student
$115.00
Member
$355.00
Non-Member
$475.00
Items Included in the Purchase of this Course
Live Web Event Icon
$60.00 - $240.00
Non-Member
$240.00
Member
$180.00
Student
$60.00

Part 1: Technologies to Facilitate High-Dose SC Administration

Live stream web event: Thu, February 23, 2023 @ 11:00 AM EST
Live Web Event Icon
$60.00 - $240.00
Non-Member
$240.00
Member
$180.00
Student
$60.00

Part 2: Trial Designs and Regulatory Considerations for SC Development Paths

Live stream web event: Thu, February 23, 2023 @ 3:00 PM EST
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