Questions and Answers
What should be reported prior to their implementation?
What is the purpose of filing Annual/Biannual reports with regulatory agencies?
What is maintained for each drug product?
What is the main objective of biosecurity?
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What is the role of a regulatory agency?
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What is the purpose of taking part in design control?
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What is the difference between biosecurity and biosafety?
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What are supplements/amendments related to?
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What is the purpose of filing supplements/amendments with regulatory agencies?
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What is the result of not distinguishing between biosecurity and biosafety?
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Study Notes
Regulatory Affairs and Bioethics
- Regulatory affairs is a profession that deals with the interface between the pharmaceutical/biotechnology industry and regulatory agencies (e.g., FDA, EU).
- It involves ensuring compliance with regulations, laws, and guidelines to protect human health and safety.
Role of Regulatory Affairs Professionals
- Act as a liaison with regulatory agencies and scientific teams
- Prepare and submit regulatory documents (e.g., NDA, ANDA, IND, MAA, DMF)
- Ensure adherence to GMP, ICH, GCP, and GLP guidelines
- Provide regulatory expertise and intelligence to companies
- Advise companies on regulatory aspects and climate that may affect their business
Goals of Regulatory Affairs
- Protection of human health
- Ensuring safety, efficacy, and quality of drugs
- Ensuring appropriateness and accuracy of product information
Role in Product Development
- Involved in product development from the beginning
- Ensure compliance with regulations during development, clinical trials, and marketing
- Help companies save time and money by advising on regulatory requirements
Bioethics and Biosafety
- Bioethics deals with the ethics of biological research and its applications
- Biosafety refers to the safe handling and containment of biological agents
- Biosecurity is a concept that emerged in 2003, distinct from biosafety, focusing on protecting people from deliberate harm
Bio-Business and Entrepreneurship
- Regulatory affairs is crucial in bio-business and entrepreneurship
- Professionals in regulatory affairs play a key role in ensuring compliance with regulations, leading to successful commercialization of products
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Description
This quiz covers regulatory affairs related to bio-safety, laboratory bodies, and their regulations. It also touches on medical and pharmaceutical aspects.
