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Posted: February 9th, 2023

Regulatory Landscape – European Union versus Rest of the World (ROI)

Regulatory Landscape of Pharmaceutical Business
The regulatory landscape for the pharmaceutical business is complex and varies by country. In general, pharmaceutical companies must comply with a range of regulations in order to bring their products to market, including regulations related to the development, testing, manufacturing, and marketing of drugs.

Some of the key regulatory bodies and agencies that oversee the pharmaceutical industry include:

Food and Drug Administration (FDA): The FDA is a US government agency responsible for regulating the safety and effectiveness of drugs, medical devices, and other healthcare products. The FDA reviews and approves new drugs and medical devices before they can be sold in the US, and also monitors the safety of drugs once they are on the market.

European Medicines Agency (EMA): The EMA is a European Union agency responsible for the scientific evaluation, supervision, and safety monitoring of medicinal products. The EMA reviews and approves new drugs and medical devices for use in the European Union, and also monitors the safety of drugs once they are on the market.

World Health Organization (WHO): The WHO is a United Nations agency responsible for global public health. The WHO sets standards and guidelines for the development and manufacturing of pharmaceutical products, and also monitors the safety of drugs on a global scale.

In addition to these regulatory bodies, pharmaceutical companies must also comply with various laws and regulations related to the development, testing, and marketing of drugs. This includes laws related to intellectual property, advertising, and clinical trials.

The regulatory landscape for the pharmaceutical industry is complex and ever-changing, and companies must navigate a range of regulations in order to bring their products to market. It is important for pharmaceutical companies to have a thorough understanding of these regulations in order to ensure compliance and avoid legal and reputational risks.

Lecturer Name: Philip Byrne
Subject: Regulatory Landscape of Pharmaceutical Business
Assignment Title CA#2 Regulatory Landscape – European Union versus Rest of the World (ROI)
Assignment details: This assignment relates to the regulatory landscape of the Pharmaceutical Industry and Biosimilars.

Your tutor may require you to attend an interview to explain your approach to the assignment, your resources used and to discuss your opinion (backed by valid examples) on the topics.
Part A: 50%
Summarize and explain in your own words the Regulations and Directives that apply to Biosimilars.

Part B: 50%
Research and summarize (in your own words) the EU actions in relation to Biosimilars reaching patients and compare it to ROI.
Include in your answer a comprehensive account of your opinion on whether the regulatory landscape of the Pharmaceutical Industry goes far enough to ensure patient safety in relation to Biosimilars.
Word/Page count: Notes on this assignment:
Part A: Minimum word limit is 2000 and Max word limit is 4000 words. Penalties may apply if these guidelines snot adhered to.

Part 2: Minimum word limit is 3000 and Max word limit is 6000 words. Penalties may apply above the limit. To be submitted / uploaded to Moodle before midday on 27th January 2023.
Submission details: Submit your assignment as one paper.
Softcopy of assignment in Word format on Moodle. Turnitin guideline % is 15 % similarity or less.
This assignment will be worth 50% of the overall module marks.
Additional Information:

Clarity in the identification of relevant Regs or absence of Regs to the argument. Clarity on the identification / explanation of EU and ROI actions., Variety and spread of the examples used to illustrate understanding Comprehensiveness and persuasiveness of the argument Clarity of referencing
10 40 30 10

Grading Scheme for the Assignment

Criteria Descriptor Clarity in the identification of relevant Regs or absence of Regs to the argument. Clarity on the identification / explanation of EU and ROI actions., Variety and spread of the examples used to illustrate understanding Comprehensiveness and persuasiveness of the argument Clarity of referencing
Weighting to total 100 10 40 30 10 10
70-100 Great clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating extensive research. Demonstrating a full understanding of the topic, siting specific regulators and situations. Great clarity on the explanation of Innovative products /initiatives. Demonstrating extensive research from peer regulatory sources and reviewed journals. Demonstrating a full understanding and application of EU and ROI actions., Great Variety and spread of the examples used to illustrate understanding. Demonstrating extensive research from peer reviewed journals. . Evidence of extensive familiarity with the topic Clear understanding of the topic. Comprehensive referencing system
60-69 Good clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating extensive research. Demonstrating a full understanding of the topic, siting specific regulators and situations.. Good clarity on the explanation of Innovative products /initiatives. Demonstrating extensive research from peer regulatory sources and reviewed journals. Demonstrating a full understanding and application of EU and ROI actions., Good Variety and spread of the examples used to illustrate understanding. Demonstrating extensive research from peer reviewed journals. Evidence of good familiarity with the topic Good referencing system
50-59 Some clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating effective research. Demonstrating a some understanding of the topic, siting specific regulators and situations. Some clarity on the explanation of Innovative products /initiatives. Demonstrating some research from peer regulatory sources and reviewed journals. Demonstrating a good understanding and application of EU and ROI actions., Some Variety and spread of the examples used to illustrate understanding. Demonstrating some research from peer reviewed journals. Evidence of some familiarity with the topic. Acceptable referencing system
40-49 Reasonable clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating effective research. Demonstrating a some understanding of the topic, siting specific regulators and situations. Reasonable clarity on the explanation of Innovative products /initiatives. Demonstrating some research from peer regulatory sources and reviewed journals. Demonstrating a good understanding and application of EU and ROI actions., Reasonable Variety and spread of the examples used to illustrate understanding. Demonstrating some research from peer reviewed journals. Evidence of reasonable familiarity with the Regulation. Reasonable understanding of the topic. Limited referencing system
Criteria Descriptor Clarity in the identification of relevant Regs or absence of Regs to the argument. Clarity on the identification / explanation of EU and ROI actions., Variety and spread of the examples used to illustrate understanding Comprehensiveness and persuasiveness of the argument Clarity of referencing
Weighting to total 100 10 40 30 10 10
31-39 Poor clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating poor research. Demonstrating little understanding of the topic, siting specific regulators and situations. Poor clarity on the explanation of Innovative products /initiatives. Demonstrating poor research from peer regulatory sources and reviewed journals. Demonstrating a poor understanding and application of EU and ROI actions., Poor Variety and spread of the examples used to illustrate understanding. Demonstrating poor research from peer reviewed journals. Evidence of poor familiarity with the Regulation. Poor understanding of the topic. Poor referencing system
0-30 Little / no clarity in the identification of the standards, guidelines and procedures or the lack thereof. Demonstrating little / no research. Demonstrating little understanding of the topic, siting specific regulators and situations. little / no clarity on the explanation of Innovative products /initiatives. Demonstrating little / no research from peer regulatory sources and reviewed journals. Demonstrating little / no understanding and application of EU and ROI actions., little / no Variety and spread of the examples used to illustrate understanding. Demonstrating little / no research from peer reviewed journals. Evidence of little / no familiarity with the Regulation. little / no understanding of the topic. Inadequate referencing system

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