BTRA 642 University of Maryland Global Biotechnology Business Issues Paper

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1) writing assignment, find a case where a company or entity received marketing approval in one or multiple European countries (i.e., did not go through the EMA centralized process). In a 2-4 page double spaced essay, give some background about the case and why the company/entity did not proceed through the EMA process.

2) What is the role of the EMA in Europe? Why was it established?

3) How do the roles of the EMA differ from those of the US FDA?

4) Biologics are regulated differently from drugs. In your own words, provide one answer that you feel explains why biologics are different from drugs

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