Order Description;

7 – 10 minute presentation on some aspect of drug regulatory affairs or the legal aspects of drug or device development.please provide  power-point and make well organized. Also Add speakers notes .provide  references to read more about the topic.


Good Clinical Practice (GCP)

Good Clinical Practice (GCP) refers to the international ethical and scientific quality standard for conducting, designing, recording, and reporting the trials that involve the participation of human subjects in drugs testing. Compliance with the standard provides public assurance that the rights, well-being, and safety of trial individuals are well protected in line with the principles of Helsinki Declaration (McGuire, Correa, Johnson, & Wienandts, 2006). The aim of the ICH GCP guidance is to provide a unified standard for the European Union member states in order to facilitate the mutual acceptance of clinical data by the regulatory authorities.

Clinical trials should be conducted in accordance with the ethical principles that are declared in the Helsinki Declaration and must be consistent with the applicable regulatory requirements (McGuire, Correa, Johnson, & Wienandts, 2006). The rights, well-being, and safety of the subjects being used for trial are the most vital considerations and they should be considered first over the interests of science and society. Before a trial is started, predictable risks and any inconveniences should be calculated against the expected benefit for the individual trail subject and the society. Therefore, a trial should only be carried out if the expected benefits justify the risks. The existing non-clinical and clinical information on a drug under investigation should be adequate to support the proposed clinical trial (McGuire, Correa, Johnson, & Wienandts, 2006). In addition to this, the clinical trials should be scientifically sound and described in a detailed, clear protocol.

A qualified medical practitioner should always handle the medical decisions made and the medical care offered to on behalf of the trial subject. All the individuals involved in this process must be competent, qualified by education, training, and posses’ vast experience in the medical field. Prior to the clinical trial participation, the practitioners should obtain freely informed consent from every subject. Confidentiality of records that could in any way identify the subjects should be protected, thereby respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements. The products to be used in investigations should be manufactured, stored, and handled in accordance with applicable good manufacturing practice and in agreement with the approved protocol. There should be implementation of systems with procedures that guarantee the quality of every aspect of the trial to be conducted (McGuire, Correa, Johnson, & Wienandts, 2006).

Obligations of Investigators and Sponsors

A regulatory sponsor refers to the person or persons who obtains the IND, thus when a Penn investigator files an FDA IND application, he or she definitely accepts the role iof a regulatory sponsor and takes responsibility for and starts a clinical investigation (Arbit, Harvey & Paller, 2006). The IND sponsor has responsibilities such as selection of qualified investigators to participate in the clinical study. The sponsor should also provide the investigator with training and vital information that they require to conduct their investigations such ensuring all the investigators are well informed of the significant new unfavorable or risks associated with the use of the product being used for investigation. The IND sponsor should ensure that that all the clinical investigators are supplied with brochures before they start their investigations.

The sponsor should obtain information from the investigator before giving the investigator a chance to proceed with the investigation. The most important documents that contain important information includes a signed FDA form 1572, which is the investigator’s statement, curriculum vitae or other qualifying documents, and the investigator’s financial disclosure information (Arbit, Harvey & Paller, 2006). The sponsor should also ensure that the investigation is conducted in accordance with the investigational plan and the protocol outlined in the IND. He should also ensure proper monitoring of the investigations by selecting a qualified monitor with experience and training to monitor how the investigations are conducted. The sponsor has the obligation to terminate or suspend a trial when deemed appropriate, and should maintain control of the investigational product by ensuring safety, manufacturing, packaging, and labeling information on such products. The sponsor should also ensure proper handling, supply, and disposal procedures of the investigational products.

HIPAA Regulations

HIPAA refers to the federal law that grants an individual the rights over his or her health information and sets rules and limits on who can access and or look at the individual’s heath information. Every individual has the right to see and get a copy of his or her health records, have corrections added to their health information, receive notice in case the health information is to be used or shared, and acquire a report of when and why the individual’s health information was used. All the doctors, nurses, hospitals, pharmacists, and nursing homes must adhere to the rule. In addition, the health insurance companies and other government programs that pay for healthcare must follow its regulations.

The HIPAA electronic data requirements are meant to encourage the health care industry to move the handling and transmission of patient information from manual to electronic systems in order to improve security, lower costs, and lower the error rate (Annas & George, 2003). HIPAA protects the information that doctors and nurses give about a person’s health records, the conversations held with doctors about care or treatment, billing information about the healthcare provider, information recorded in the insurer’s computer system, and to make sure that an individual’s information is protected in a way that does not interfere with the healthcare.

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