BTRA 642. Global Biotechnology business issues
Description
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?
| Excellent | Good | Fair | Poor | ||
| Main Postinga | 45 (45%) – 50 (50%)
Answers all parts of the discussion question(s) expectations with reflective critical analysis and synthesis of knowledge gained from the course readings for the module and current credible sources.
Supported by at least three current, credible sources.
Written clearly and concisely with no grammatical or spelling errors and fully adheres to current APA manual writing rules and style. |
40 (40%) – 44 (44%)
Responds to the discussion question(s) and is reflective with critical analysis and synthesis of knowledge gained from the course readings for the module.
At least 75% of post has exceptional depth and breadth.
Supported by at least three credible sources.
Written clearly and concisely with one or no grammatical or spelling errors and fully adheres to current APA manual writing rules and style. |
35 (35%) – 39 (39%)
Responds to some of the discussion question(s).
One or two criteria are not addressed or are superficially addressed.
Is somewhat lacking reflection and critical analysis and synthesis.
Somewhat represents knowledge gained from the course readings for the module.
Post is cited with two credible sources.
Written somewhat concisely; may contain more than two spelling or grammatical errors.
Contains some APA formatting errors. |
0 (0%) – 34 (34%)
Does not respond to the discussion question(s) adequately.
Lacks depth or superficially addresses criteria.
Lacks reflection and critical analysis and synthesis.
Does not represent knowledge gained from the course readings for the module.
Contains only one or no credible sources.
Not written clearly or concisely.
Contains more than two spelling or grammatical errors.
Does not adhere to current APA manual writing rules and style. |
|
| Main Post: Timeliness | 10 (10%) – 10 (10%)
Posts main post by day 3. |
0 (0%) – 0 (0%) | 0 (0%) – 0 (0%) | 0 (0%) – 0 (0%)
Does not post by day 3. |
|
| First Response | 17 (17%) – 18 (18%)
Response exhibits synthesis, critical thinking, and application to practice settings.
Responds fully to questions posed by faculty.
Provides clear, concise opinions and ideas that are supported by at least two scholarly sources.
Demonstrates synthesis and understanding of learning objectives.
Communication is professional and respectful to colleagues.
Responses to faculty questions are fully answered, if posed.
Response is effectively written in standard, edited English. |
15 (15%) – 16 (16%)
Response exhibits critical thinking and application to practice settings.
Communication is professional and respectful to colleagues.
Responses to faculty questions are answered, if posed.
Provides clear, concise opinions and ideas that are supported by two or more credible sources.
Response is effectively written in standard, edited English. |
13 (13%) – 14 (14%)
Response is on topic and may have some depth.
Responses posted in the discussion may lack effective professional communication.
Responses to faculty questions are somewhat answered, if posed.
Response may lack clear, concise opinions and ideas, and a few or no credible sources are cited. |
0 (0%) – 12 (12%)
Response may not be on topic and lacks depth.
Responses posted in the discussion lack effective professional communication.
Responses to faculty questions are missing.
No credible sources are cited. |
|
| Second Response | 16 (16%) – 17 (17%)
Response exhibits synthesis, critical thinking, and application to practice settings.
Responds fully to questions posed by faculty.
Provides clear, concise opinions and ideas that are supported by at least two scholarly sources.
Demonstrates synthesis and understanding of learning objectives.
Communication is professional and respectful to colleagues.
Responses to faculty questions are fully answered, if posed.
Response is effectively written in standard, edited English. |
14 (14%) – 15 (15%)
Response exhibits critical thinking and application to practice settings.
Communication is professional and respectful to colleagues.
Responses to faculty questions are answered, if posed.
Provides clear, concise opinions and ideas that are supported by two or more credible sources.
Response is effectively written in standard, edited English. |
12 (12%) – 13 (13%)
Response is on topic and may have some depth.
Responses posted in the discussion may lack effective professional communication.
Responses to faculty questions are somewhat answered, if posed.
Response may lack clear, concise opinions and ideas, and a few or no credible sources are cited. |
0 (0%) – 11 (11%)
Response may not be on topic and lacks depth.
Responses posted in the discussion lack effective professional communication.
Responses to faculty questions are missing.
No credible sources are cited. |
|
| Participation | 5 (5%) – 5 (5%)
Meets requirements for participation by posting on three different days. |
0 (0%) – 0 (0%) | 0 (0%) – 0 (0%) | 0 (0%) – 0 (0%)
Does not meet requirements for participation by posting on 3 different days. |
|
| Total Points: 100 | |||||