Who submits the post marketing safety report of drugs

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Reference no: EM133240132

Global Biotechnology Business Issues Assignment -

1) Mention 3 cultural/regional influences that may cause differences beetween the US and the Japan approval process (include references as needed)

2) For a US pharmaceutical company, who submits the post marketing safety report of drugs for product commercialized in Japan?

3) PMDA accept and review foreign clinical data of medical devices which are applied for Marketing approval in Japan True or False?

4) What is the purpose of having a PMDA prior assessment consultation?

5) What do you consider are the key factors for a regulatory professional to have a succesfull PMDA consultation meeting? 6) What do you think of policies in countries like Japan and China that mandate that a medical product seeking marketing approval have citizens of that country in clinical trials used to support the application?

7) What do you think of the fact that the members of the various review committees that make up South Africa's MCC are not full-time employees? Does this have an impact on aspects of regulation other than waiting times?

8) Lot release is a unique requirement. Do you think biologics should be subject to lot release when drugs are not? Why or why not?

Reference no: EM133240132

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