This workshop continues USP’s efforts to inform public standard setting for therapeutic peptides and peptide vaccines while introducing similar considerations for therapeutic oligonucleotides.
Key Session Topics:
- Challenges in measurement and specification setting, particularly for impurities
- Innovative analytical and manufacturing technologies
- Bioassays for complex products
- Peptide vaccines: analytical and regulatory strategies
- Oligonucleotide products
- Peptide and oligonucleotide standards
- Regulatory expectations for peptides and oligonucleotides
- Raw materials
- Manufacturing and control strategies
- To better understand USP’s standards for peptide and oligonucleotide products
- To learn about new peptide and oligonucleotide targets and novel advances in manufacturing, purification technologies, analytical methods strategies and bioassay
- To learn regulatory expectations for peptides, conjugated peptides, peptide vaccines and oligonucleotide therapies
- To achieve common regulatory understanding between USP, industry, and Regulatory Agencies
- To network with other manufacturers, scientists, and regulators in this area
- To provide feedback about proposed changes/new information on peptide monograph(s) and chapter(s)
- To explore compendial science topics in order to inform the development of specific monograph(s) and chapter(s)
Who Should Participate?
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Team members in CMC development projects
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
|Participant type||Regular fee per person (1-2 individuals from the same organization)||Early bird discount (register by September 28, 2019)||Multi-registrant pricing (3 or more individuals from the same organization; all must register at the same time to receive discount)|
*Connection information for Virtual Participants will be sent three (3) business days prior to event.
Advance Registration Deadline
Advance Registration will be available through Thursday, October 31, 2019; 12 noon EST. On-site registration will be available starting at 8 am, Monday, November 4, 2019 at the USP Meetings Center.
Cancellation and Substitution Policy
Cancellation must be received on or before October 5, 2019 via email to firstname.lastname@example.org
Refunds will not be issued for cancellations received after this date. There is a $50 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 email@example.com
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.
Please contact firstname.lastname@example.org 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.