A Guidance Forum Workshop, presented by AAPS, will take place September 11-12, 2018, in Silver Spring, MD. The focus of the workshop will be to discuss challenges, issues and concerns for the FDA guidance documents that are most important to AAPS members. From a poll of stakeholders, two guidance documents have been selected for this forum:
- Drug products, including biological products, that contain nanomaterials. Draft guidance for industry, December 2017.
- Assay development and validation for immunogenicity testing of therapeutic protein products. Draft guidance for industry, April 2016.
Day 1 of the workshop will focus on the nanomaterials guidance document, and day 2 of the workshop will be dedicated to the immunogenicity testing of therapeutic proteins guidance document. Both days will feature plenary speakers and have breakout-style sessions on several topics. This format will provide ample opportunity for participants to engage in open dialogue with regulators, academia and industry scientists, with the goal of providing insight into the guidance requirements for submission of regulatory applications.
Registration is now open: https://www.aaps.org/education-and-research/workshops/guidance