6212_Assignment 1 (2) (1)

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Feb 20, 2024

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1 RGA6212 Introduction to Safety Sciences Assignment - 1 Topic: The Investigator’s Brochure Submitted by Aarthi Pathi NUID: 002649231 Submitted to Prof. Linford Leitch

2 1. Title and purpose of the brief: Title : Developing and Publishing an Investigator's Brochure for "LOCOR"; Meeting All Regulatory Requirements; Emphasizing Key Safety Data. Purpose : This document is meant to serve as a guide for our team as they work to build and create an Investigator's Brochure for our drug/device combination product, "LOCOR," a novel statin for the treatment of low-density lipoprotein (LDL) cholesterol. The paper will emphasize critical safety facts pertaining to the drug/device combination product and ensure compliance with regulatory regulations set out by the FDA and EMA. This will aid our team in overseeing clinical trials and ensuring the safety of study participants throughout the entire trial period, as well as collecting pertinent data on the investigational product obtained during preclinical and other clinical studies involving human subjects. For physicians or potential investigators to comprehend the information and make an unbiased risk-benefit assessment on whether or not the research is appropriate, it must be presented in a concise, clear, impartial, balanced, straightforward, and non-promotional manner. (“Investigator’s Brochure”) 2. Intended audience: When working for a pharmaceutical firm, it is common practice for many employees to review the Investigator's Brochure (IB). As an example: Workgroup for Clinical Development: Clinical trial planners and implementers make up the clinical development team. The IB helps them learn about the drug's effectiveness, safety, and mechanism of action in both preclinical and clinical investigations. Staff writers for medical journals: It is the duty of the medical writing staff to draft the necessary regulatory papers, including the IB. During the whole course of clinical development, they design and revise the IB. Regulatory filings, including the IB, are the responsibility of the regulatory affairs team, which works to gain permission from relevant authorities. They make certain the IB delivers the required data on the drug's safety and effectiveness and complies with all applicable regulations. The quality assurance group is responsible for making sure the IB is correct, up-to-date, and follows all applicable regulations. Prior to publication, the IB is vetted and approved by them. Investigators in clinical trials are the people who really do the work of running the studies, from recruiting participants to making sure they get their doses of the experimental medicine. They go to the IB for guidance on things like dose, side effects, and other safety considerations related to the medicine. Managers in charge of the drug-development project have ultimate accountability for its success or failure. They demand that the IB check in on the drug development process to make sure everything is going as planned and to spot any emerging safety issues. (ICH)

3 3. Description of E6(R2) Section 7: Investigator’s Brochure: ICH E6(R2) is an annex to ICH E6(R1), which outlines Good Clinical Practice (GCP) and "a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions." The purpose of this guideline is to guarantee that human subjects' rights, safety, and well-being are respected throughout clinical trials by providing advice on the conduct of clinical trials and the duties of sponsors, investigators, and ethics committees. (“What Is ICH E6(R2)?”) All aspects of safety reporting are covered in detail in E6(R2), from creating safety management plans to gathering and analysing safety data to disseminating that data to the appropriate parties. It also stresses the significance of risk management at every stage of the clinical trial, from identifying hazards to implementing countermeasures and keeping an eye on things to make sure everything is safe. Adherence to E6(R2) is essential in the context of drug and biologic development to guarantee the security of clinical trial participants. The guideline stresses the significance of ongoing safety evaluation and communication between the trial's sponsor, investigators, and regulatory authorities. In order to guarantee the safe and ethical conduct of clinical trials and, ultimately, better patient outcomes, drug and biologic developers should adhere to the criteria established in E6(R2). (ICH) The IRB/IEC should have members with the requisite skills and expertise to analyse and evaluate the science, medical aspects, and ethics of planned clinical trials. At least five people are needed on the IRB/IEC; one should not be particularly concerned with scientific topics, and another should not be affiliated with the institution or trial location. When making decisions on the study, only members of the IRB/IEC who are not affiliated with the investigator or the sponsor should have their say. Further, it is important to keep track of the individuals who serve on the IRB/IEC and their respective credentials. Compliance with Good Clinical Practice (GCP) and other applicable regulatory standards is essential for the IRB/IEC, as is the maintenance of documented operating procedures, records, and meeting minutes. All necessary votes must take place at scheduled meetings attended by a quorum established under the governing documents. Participants in the review and debate should be the only ones to cast a vote or offer feedback. Researchers can weigh in on any topic related to the study, but they are not allowed to take part in the IRB/IEC's discussions or votes. The IRB/IEC has the option of calling on non-members with specialized knowledge for assistance. While the IRB/IEC is not required to follow these suggestions, they will serve as a useful guide. (E6(R2) Good Clinical Practice: Guidance for Industry) To ensure the safe and successful conduct of the study, the Investigator's Brochure (IB) should give thorough information to investigators in compliance with the ICH E6(R2) standard. The Institutional Review Board/Independent Ethics Committee (IRB/IEC) must approve the study before it can begin, based on their assessment of the IB and whether or not it will adequately support the trial's conduct. To ensure that investigators can understand and make use of the material in the IB, it should be prepared in a straightforward and succinct fashion. All relevant details regarding the investigational product, including its make-up, pharmacological and toxicological effects, and known or suspected dangers, must be included in the IB. The IB must also include adequate instructions for administering and storing the investigational substance. As new data on either the trial's safety or effectiveness becomes

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