Christopher Bravery

Company: Consulting on Advanced Biologicals Ltd

Job title: Consulting Regulatory Scientist

Seminars:

Benchmarking the State of Regulatory Expectations on Stability & Release Characterization 2:00 pm

• Hearing about the current expectations from regulators on stability and release characterization • Outlining the best methods for stability and release characterization to meet these expectations • Using results from these tests and guidance from regulators to store batchesRead more

day: Day Two AM

Developing an Appropriate Potency Assay to Support Comparability & Aid in Regulatory Approvals 1:00 pm

Utilizing appropriate potency assays are of utmost importance when attempting to prove comparability to regulators, so the design of these assays should be of consideration when undergoing or planning for comparability studies. This session will delve into the development of these potency studies from the perspective of regulators. Key learnings from this workshop: • Understanding…Read more

day: Regulatory Workshop Day