5th Bioassay Workshop
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.
- 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
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.
- Biopharmaceutical/biotechnology industry professionals
- Biopharmaceutical development scientists
- Pharmaceutical industry professionals
- Regulatory experts for biologics
- Biosimilar manufacturers
- Bioassay practitioners and software experts
- Analytical development scientists
- QA/QC specialists for biologics
- Industry—$950; AAG—$500
- Industry—$850; Academia/Association/Govt. (AAG)—$400
- 3 or more attendees from the same company: $700 per person
- 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 email@example.com for details.