Order ID:89JHGSJE83839 | Style:APA/MLA/Harvard/Chicago | Pages:5-10 |
Instructions:
Medical Device for Atrial Fibrillation Treatment
I need help with a Business Law question. All explanations and answers will be used to help me learn.
Simulate the role of a Regulatory Affairs manager in identifying the key differences between pharmacovigilance practices for drugs/biologics vs. medical devices
Demonstrate understanding of the relevant Safety Reporting guidelines for drugs and devices in the US and EU, specifically
Apply knowledge of the relevant Safety Reporting regulations for drugs, biologics, and devices in a real-world setting
Imagine you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company that is looking to develop a new medical device for the treatment of atrial fibrillation, also known as irregular/rapid heartbeat. To-date, your company only has experience with the pharmacovigilance practice related to the development of drugs/biologics. Your device is similar to a pacemaker in that it is an implantable electronic device that will be placed in a certain location within the heart muscle of a patient and will be left there for several years to regulate the heartbeat.
Your company is preparing to embark on medical device trials in the United States and Spain.
Your task is to provide the following information to your colleagues in the form of an executive summary (incorporation of figures and graphs HIGHLY encouraged):
Introduction (1 paragraph)
Provide a general introduction for your colleague to explain the purpose of this briefing document and what types of information you plan to include and why.
Outline the Key Players (2-3 paragraphs)
Regulatory Oversight for Devices: In each of the 2 countries (US, Spain), what regulatory bodies are tasked with providing direct oversight to:
Medical Device pre-market development
Medical Device Pharmacovigilance – hint: In Spain, you will need to address this on two levels: The European Commission’s role and the role of The Spanish Agency of Medicines and Medical Devices (AEMPS)
FDA Medical Device Requirements (3-4 paragraphs)
Describe the different FDA classifications for medical devices. Be sure to clearly outline how risk plays a role in the classification of devices and explain why your company’s device, which is intended to regulate the heartbeat, will most likely be classified as a Class III device.
Identify and outline, in your own words, the key areas under the Code of Federal Regulations that pertain to pre-market medical device pharmacovigilance as conducted under an Investigation Device Exemption (IDE).
What types of medical devices fall under this part of the code?
What is the pharmacovigilance/safety relevant concepts introduced in the code?
What safety-related definitions are introduced that are different from what your company is used to seeing with drugs/biologics?
What are the expedited reporting details? What events meet these criteria and what are the timeframes?
European Commission Device Requirements (3-4 paragraphs)
Describe the different EC classifications for medical devices. In what ways are they similar or different from those employed by the FDA? Be sure to clearly outline how risk plays a role in the classification of devices and explain why your company’s device, which is intended to regulate the heartbeat, will most likely be classified as a Class III device.
Identify and outline, in your own words, the key areas under the EU MDR that pertain to pre-market medical device clinical investigations:
What is the pharmacovigilance/safety relevant concepts introduced in the EU MDR?
What safety-related definitions are introduced that are different from what your company is used to seeing with drugs/biologics?
What are the expedited reporting details? What events meet these criteria and what are the timeframes, if any?
Optional: While Spain is an EU member state and therefore comes under the EC medical device rules, what role with Spain’s Competent Authority, The Spanish Agency of Medicines and Medical Devices (AEMPS), play with respect to safety reporting for the medical device while it is undergoing clinical trials in Spain
Conclusion/Next Steps (1-2 paragraphs)
What resources will you use to help your company understand the pharmacovigilance regulations related to clinical trials of medical devices in the US and EU?
Will you recommend any specific vendors to help manage safety reporting during clinical trials of your device? Feel free to take this in a creative direction.
Medical Device for Atrial Fibrillation Treatment
RUBRIC |
||||||
Excellent Quality 95-100%
|
Introduction
45-41 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned. |
Literature Support 91-84 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned. |
Methodology 58-53 points Content is well-organized with headings for each slide and bulleted lists to group related material as needed. Use of font, color, graphics, effects, etc. to enhance readability and presentation content is excellent. Length requirements of 10 slides/pages or less is met. |
|||
Average Score 50-85% |
40-38 points More depth/detail for the background and significance is needed, or the research detail is not clear. No search history information is provided. |
83-76 points Review of relevant theoretical literature is evident, but there is little integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are included. Summary of information presented is included. Conclusion may not contain a biblical integration. |
52-49 points Content is somewhat organized, but no structure is apparent. The use of font, color, graphics, effects, etc. is occasionally detracting to the presentation content. Length requirements may not be met. |
|||
Poor Quality 0-45% |
37-1 points The background and/or significance are missing. No search history information is provided. |
75-1 points Review of relevant theoretical literature is evident, but there is no integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are not included in the summary of information presented. Conclusion does not contain a biblical integration. |
48-1 points There is no clear or logical organizational structure. No logical sequence is apparent. The use of font, color, graphics, effects etc. is often detracting to the presentation content. Length requirements may not be met |
|||
You Can Also Place the Order at www.collegepaper.us/orders/ordernow or www.crucialessay.com/orders/ordernow
Medical Device for Atrial Fibrillation Treatment |
Medical Device for Atrial Fibrillation Treatment