Registration Good news! Early bird pricing is in effect until September 11, 2023.
Pharmaceutical reference standards play a vital role in drug development and production and are essential for the quality control of medicines. This symposium will bring together stakeholders involved in the manufacture, characterization and use of reference standards to exchange views and share experiences on the different issues related to the subject.
The programme will cover the use and establishment of reference standards, with an emphasis on reference standards for biologicals and small molecules, as well as regulatory expectations and harmonisation across different regions.
Specific topics on the agenda will include the role of pharmaceutical reference standards during the pharmaceutical lifecycle, scientific consideration during their development and characterization, the role of compendial reference standards and regulatory perspectives on impurities standards. The final session will feature round table breakout sessions with Q&A with USP and EDQM representatives.
Participants will have a unique opportunity to interact with key stakeholders and organizations from around the world involved in the development, manufacture, distribution and use of reference standards.
- Reference standards during the pharmaceutical product lifecycle
- Characterization of Reference standards
- Stability assessment for small and large molecules
- Role of Compendial Reference standards
- Regulatory perspectives on impurity standards
Who should participate
- Scientists and engineers from industry and academia who are developing/implementing/maintaining reference standards
- Quality assurance and quality control analysts/staff
- Regulatory officials
- Contract research and manufacturing organizations
Information sharing and discussion among industry leaders, regulators, experts, and stakeholders on reference standard and related topics:
- Increased understanding of the current regulatory landscape and regulators’ perspective on reference standards
- Active engagement and networking among workshop attendees and presenters
In-person participation will take place at USP’s Rockville, MD, headquarters. There will also be a virtual option for those who cannot attend in person. If you have any questions about registration, travel or local accommodations, please email Events@USP.org.