5th Bioassay Workshop

December 4, 2012 - December 5, 2012

Overview

Overview: 

The 5th Bioassay Workshop is built on past USP workshops and focused on the use of bioassay data sets and case studies to address compliance challenges as new USP chapters become official with the First Supplement to USP 35–NF 30. Beyond general bioassay guidance, the workshop will focus on assay-specific or product-specific challenges, the reagents and standards necessary to derive reliable potency results, and modern software aids that are common tools in the bioassay laboratory.

[VIDEO] Watch Dr. Michael Mulkerrin on USP's Bioassay workshop.

Topics: 
  • Life Cycle Management with <1032>, <1033>, and <1034>
  • Assay-Specific Case Studies
  • Life Cycle Management of Reference Standards and Critical Reagents in Potency Bioassays
  • Application of New Technologies to the Field of Bioassays
  • Demonstrations and Discussion Sessions with Software Vendors

Related Resources

In conjunction with the workshop, USP is offering a Pharmacopeial Education (PE) course: Bioassay Validation <1032>, <1033> and <1034> on December 3. The course will address the fundamentals of bioassay practices and principles along with associated statistical concepts. A discount is available to registrants of both events.

Who Should Participate: 
  • 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

Agenda

Registration Information

Regular Price Information: 
  • Industry—$950; AAG—$500
Early Discount Information: 
  • Industry—$850; Academia/Association/Govt. (AAG)—$400
Early Registration Deadline: 
October 31, 2012
Group Discount Information: 
  •  3 or more attendees from the same company: $700 per person
Other Registration Information: 
  • Software Vendor—$2,000
  • Poster Presenter—$500
  • Student (must present valid student ID)—$200
  • Registration for both Workshop & PE Course: Industry—$1,100 (before 10/31)/$1,200; (AAG)—$650 (before 10/31)/$750

Registration fee includes full two-day program, meeting materials, continental breakfast and lunch each day, and a networking reception. Contact conferences@usp.org for details.

12601 Twinbrook Parkway
Rockville, MD 20852
United States
Phone: +1-301-816-8136
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