BTRA 642. Global Biotechnology business issues


1) The final writing assignment for this term will give you a chance to look inward on the field of regulating medical products. What are your impressions of the culture created by the people working in this field? Would any changes in the culture effect meaningful change in the regulatory process? If so, what would that be? Remember to focus your thoughts on an international level and feel free to use country region-specific examples to support your reasoning. For this assignment write 2-3 pages. 

2) 1-2 pages

Critique a Product Support: Using the internet, choose an approved drug product of interest for which information is available on health agency websites.  Retrieve publicly available information and comment on the associated testing.  Provide a brief summary of what testing was conducted and what the studies showed were potential adverse effects.  Discuss the strengths and weaknesses of the testing program as support for the regulatory requirements for market release. 

3) What impacts of culture and the expectation of privacy can you see playing a role in the use of genomic data in the development and marketing of new medical products?  

4) What are your impressions of the impact of the physician culture in the UK on incident reporting? Were your impressions any different before you read this week’s assigned readings? 

5) Which Agency incentive offers the greatest advantage? As a sponsor why would you use this incentive?

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