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B Pharm Pharmaceutical Regulatory Sciences Unit 4 PDF Notes


B-Pharmas, step into the crucial world of clinical trials in B Pharm Pharmaceutical Regulatory Sciences Unit 4 PDF Notes! Buckle up as we explore the ethical and regulatory framework that ensures participant safety and data integrity. Imagine crafting detailed clinical trial protocols, outlining the study plan and protecting participants' rights. We'll delve into the role of Institutional Review Boards (IRBs) and Independent Ethics Committees, safeguarding ethical conduct. Feeling responsible? Master the informed consent process, empowering participants to make informed decisions. But it's not just ethics; we'll equip you with the Good Clinical Practice (GCP) obligations for investigators, sponsors, and monitors, ensuring data quality and responsible conduct. Dive into the intricacies of managing and monitoring trials, ensuring smooth execution and participant well-being. Finally, understand the importance of pharmacovigilance, continuously monitoring drug safety throughout the trial. By the end of this unit, you'll be a clinical trial whiz, prepared to contribute to ethical and responsible research that advances medical science!


B Pharm Pharma Marketing Management Notes
B Pharm Pharma Marketing Management Notes

B Pharm Pharmaceutical Regulatory Sciences Unit 4 PDF Notes


Unit 4


Clinical trials

Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee - formation and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance - safety monitoring in clinical trials



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