Biologics and Biosimilars Regulatory Aspects Post Master's Certificate Postgraduate Program By Temple University |Top Universities

Program overview

Main Subject

Pharmacy and Pharmacology

Degree

Other

Study Level

Masters

Study Mode

On Campus

The Post-Master's Certificate in Biologics and Biosimilars: Manufacturing provides a broad overview of the technical aspects of biologics manufacturing.

What regulatory issues are unique to biologics and biosimilar drug manufacturers? What are the clinical, manufacturing, regulatory, and strategic issues that challenge the path to global commercialization of a biological product? What are the current regulatory and technical/scientific issues involved in developing biological products in major ICH regions? What principles guide the development of biosimilar drugs, and how does biosimilar development differ from innovator drug development? How do biologics and biosimilars differ from chemically synthesized drugs?  What analytical methods are used to characterize biologics and how does analytical testing differ from small molecule testing? What Quality by Design principles relate to development, manufacturing, and testing of biologics? Explore these issues as you pursue the Post-Master's Certificate in Biologics and Biosimilars: Regulatory Aspects.

Contact us for more information here: [email protected]


Program overview

Main Subject

Pharmacy and Pharmacology

Degree

Other

Study Level

Masters

Study Mode

On Campus

The Post-Master's Certificate in Biologics and Biosimilars: Manufacturing provides a broad overview of the technical aspects of biologics manufacturing.

What regulatory issues are unique to biologics and biosimilar drug manufacturers? What are the clinical, manufacturing, regulatory, and strategic issues that challenge the path to global commercialization of a biological product? What are the current regulatory and technical/scientific issues involved in developing biological products in major ICH regions? What principles guide the development of biosimilar drugs, and how does biosimilar development differ from innovator drug development? How do biologics and biosimilars differ from chemically synthesized drugs?  What analytical methods are used to characterize biologics and how does analytical testing differ from small molecule testing? What Quality by Design principles relate to development, manufacturing, and testing of biologics? Explore these issues as you pursue the Post-Master's Certificate in Biologics and Biosimilars: Regulatory Aspects.

Contact us for more information here: [email protected]


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