USP’s 7th Bioassay Workshop - Bioassay: A Lifecycle Approach

12601 Twinbrook Parkway
Rockville, MD 20852
United States
Phone: +1-301-816-8130
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Agenda Register


Incorporating lifecycle and QbD perspectives into bioassays is gaining traction and recognition as legitimate practice in the industry.  USP’s 7th Bioassay Workshop will give attendees the opportunity to consider and discuss lifecycle methods from scientific, statistical, and regulatory perspectives, including the presentation of case studies from various stages in an assay’s lifecycle. The role and requirements of the bioassay shift as a product emerges from research and evolves through development and commercialization. Decisions are made throughout the lifecycle of the bioassay using sound scientific principles and appropriate statistical approaches to understand the impact and risks of specific choices in assay design and development, qualification, and continued performance verification, including bioassay transfer, maintenance, updating, and retirement. A key element of the workshop will be expounding on lifecycle-oriented ideas already present in USP bioassay chapters.

Topics of the Workshop

  • Overview of a Lifecycle Approach
  • Bioassay Design and Development
  • Bioassay Qualification
  • Bioassay Performance Verification and Maintenance
  • Demonstrations and Discussion Sessions with Software Vendors

Who Should Attend

  • Biopharmaceutical/biotechnology industry professionals
  • Biopharmaceutical development scientists
  • Pharmaceutical industry professionals
  • Regulatory experts for biologics
  • Biosimilar manufacturers
  • Bioassay practitioners and software experts
  • Biostatisticians
  • Analytical development scientists
  • QA/QC specialists for biologics

Advance Registration Deadline

Advance registration will be available through September 21, 2017. After that date, registration will be available on site at the USP Meetings Center.

Please note that registering for a USP event requires an Access Point account. Please follow the instructions after clicking the “REGISTER” button

Pricing Information

Registration is payable by credit card only. Registration fee includes the full two-day program, meeting materials, coffee breaks, lunches, and a networking reception. Registration fees for this workshop have been set as follows:

Participant Type Regular Fee Per Person
(1-2 individuals from the same organization)
Early Bird Discount
(Register by July 21, 2017)
Multi-Registrant Price
(3 or more individuals from the same organization; all must register at the same time to receive the discount)

Academia Participant




Association Participant




Government Participant




Industry Participant




Student Participant




Registering Others

When registering colleagues (not yourself), please create your own Access Point account and then check the “I am registering others – not myself” box at the top of the registration form. If you are registering multiple people, please select “add additional registrants” on the final page of the registration form (before submitting payment).

Cancellation and Substitution Policy

Cancellation must be received on or before September 5, 2017 via email to

Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations; however, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to

Invitation Letters for Visas

USP cannot provide an invitation letter to potential workshop attendees; however, once you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa.

Registration Questions

Please contact or +1 301-816-8130.

Local Area Information

Visit our Travel & Transportation page for information on lodging, airports, and local transportation in and around USP’s Rockville, Maryland, campus.