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Covid-19 Safety Testing Approaches

AAPS | American Association of Pharmacueticals Scientists | Path Course Page

Rafiq Islam, Executive Director of Bioanalysis describes the approach that Celerion has taken to ensure the safety of our employees and patients via a suite of viral testing offerings. Specifically, we will share the scientific development of stringent testing methodology for both antibody titer assays as well as quantitative qPCR tests, ensuring the highest quality of reagents and procedures.

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1) Receive marketing related communications, including news, updates, promotional emails, and access to online networking tools.
2) Be identified as an attendee on lists provided to exhibiting and sponsoring companies with the following information: Name, Company, Job Title, Email, Street Address, City, State, Country.

AAPS members, students, and academicians enjoy special pricing. Previews of each of the lectures are available. Participants have access to the course content for a 6 month period following purchase.

Course Objectives

Introduce the statute, regulation and guidance relationships.

Review positioning the quality pillars (GLP, cGMP, and GCP) in eCTD submissions.

Compare and contrast critical GLP roles and responsibilities from the perspectives of the Sponsor, Study Director, Principal Investigator and Quality Assurance.

Provide a detailed understanding of the relevant GLP formulation nuances.

Review ICH Q10 in-depth.

Gain insight into the value of linking development knowledge to manufacturing, and knowledge management to continuous improvement.

Differentiate how to perform appropriate quality investigations during development and commercial batch manufacturing, and when managing investigations of external vendors such as suppliers and CROs.

Discuss pertinent models for conducting clinical research, focusing on new drug development and approval.

Understand how to put GCP into action from obtaining Informed Consent, to composing a Protocol, to selecting Clinical Sites and ending with describing the Data Review Committee.