To ensure that pharmaceutical products are safe and effective.

To develop and implement clinical trial protocols.

To conduct research on new drug therapies.

To market and sell pharmaceutical products.

Food and Drug Administration (FDA)

European Medicines Agency (EMA)

International Council for Harmonisation (ICH)

World Health Organization (WHO)

To develop and implement clinical trial protocols.

To conduct research on new drug therapies.

To market and sell pharmaceutical products.

To harmonize the regulatory requirements for pharmaceutical products across different countries.

A set of regulations that govern the manufacturing of pharmaceutical products.

A set of guidelines that recommend best practices for the manufacturing of pharmaceutical products.

A set of standards that define the quality of pharmaceutical products.

A set of procedures that are used to ensure the safety of pharmaceutical products.

To evaluate the safety and efficacy of a new drug or treatment.

To develop a new drug or treatment.

To market and sell a new drug or treatment.

To manufacture a new drug or treatment.

Phase I trials are conducted in healthy volunteers, while Phase II trials are conducted in patients with the disease or condition being studied.

Phase I trials are conducted to evaluate the safety of a new drug or treatment, while Phase II trials are conducted to evaluate the efficacy of a new drug or treatment.

Phase I trials are conducted to evaluate the pharmacokinetics of a new drug or treatment, while Phase II trials are conducted to evaluate the pharmacodynamics of a new drug or treatment.

Phase I trials are conducted to evaluate the short-term safety of a new drug or treatment, while Phase II trials are conducted to evaluate the long-term safety of a new drug or treatment.

To request approval from the FDA to market a new drug.

To request approval from the FDA to conduct a clinical trial.

To request approval from the FDA to manufacture a new drug.

To request approval from the FDA to import a new drug.

To request approval from the FDA to market a new biologic product.

To request approval from the FDA to conduct a clinical trial of a new biologic product.

To request approval from the FDA to manufacture a new biologic product.

To request approval from the FDA to import a new biologic product.

To monitor the safety of a drug or biologic product after it has been approved for marketing.

To evaluate the efficacy of a drug or biologic product after it has been approved for marketing.

To compare the safety and efficacy of two or more drugs or biologic products.

To develop new drugs or biologic products.

To identify and assess the risks associated with a drug or biologic product.

To develop strategies to mitigate the risks associated with a drug or biologic product.

To communicate the risks associated with a drug or biologic product to healthcare professionals and patients.

All of the above.

To provide patients with information about the risks and benefits of a drug or biologic product.

To provide patients with instructions on how to use a drug or biologic product.

To provide patients with information about the side effects of a drug or biologic product.

All of the above.

To describe the design and conduct of a clinical trial.

To obtain approval from the FDA to conduct a clinical trial.

To recruit participants for a clinical trial.

All of the above.

To obtain informed consent from participants in a clinical trial.

To provide participants in a clinical trial with information about the risks and benefits of the trial.

To protect the rights of participants in a clinical trial.

All of the above.

To monitor the safety of participants in a clinical trial.

To review the data from a clinical trial and make recommendations to the study investigators.

To ensure that the clinical trial is conducted in accordance with the protocol.

All of the above.

To ensure the quality and integrity of non-clinical laboratory studies.

To protect the rights of animals used in non-clinical laboratory studies.

To ensure that non-clinical laboratory studies are conducted in accordance with ethical principles.

All of the above.