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Combination Products: Regulations, Guidances, & Rules

November 28, 2017 to November 29, 2017
Washington, DC
Regulatory
Workshop

Join us for a day and a half on Combination Products.  FDA staff and industry experts will discuss important regulatory and practical issues, including the rules on GMPs, the 21st Century Cures Act, & postmarket safety reporting for combination products. 

Click here to view and download the agenda

Agenda topics to include:

  • Combination products: past, present, and future
  • PMAs, 510(k)s, 513(g)s, and combination products
  • Primary mode of action (PMOA) and request for designation (RFD)
  • Utilization the De Novo Pathway for combination products
  • Labeling and cross-labeling of combination products
  • CGMP Guidance for combination products—a flexible approach—presentations and discussion

Speakers include:

  • John (Barr) Weiner,  Office of Combination Products
  • Melissa Burns, Office of Combination Products
  • Issac Chang, Office of Surveillance and Biometrics, CDRH
  • Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions
  • Nazia Rahman, Office of Compliance, CDRH
  • Andrew Yeatts, Office of Device Evaluation, CDRH
  • Diana Yoon, Office of Combination Products

Pew Charitable Trusts Conference Center
901 E Street, N.W. / Washington, DC

Registration Fees:

AdvaMed Member Registration: $1,095.00
Accel Member Registration: $595.00
Government and Non-Profit Registration: $595.00 
Non-Member Registration: $1,595.00 

Cancellation and Refund Policy
All cancellations must be received via email to AdvaMedEvents@AdvaMed.org (link sends e-mail). Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows". 

We welcome substitutions in lieu of cancellations at any time. Please contact us at AdvaMedEvents@AdvaMed.org (link sends e-mail) with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.

Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.