Comprehensive Clinical Research And Pharmacovigilance

Master the Art of Clinical Research: From Drug Discovery to Regulatory Guidelines

What you'll learn

Drug discovery and development stages.

Global regulatory standards, including ICH and GCP.

Managing adverse drug reactions and pharmacovigilance.

Clinical research project management and outsourcing.

Conducting and analyzing bioequivalence studies.

Communication skills essential for clinical research teams.

Requirements

Basic knowledge of biology, chemistry, or healthcare concepts. Interest in drug development and clinical research. No prior experience in clinical research is required.

Description

This course provides an in-depth understanding of clinical research processes, pharmacovigilance, and the regulatory framework governing drug development. Spanning from drug discovery to bioequivalence studies, the course equips learners with the technical knowledge and skills required for careers in clinical research and related fields. Emphasis is placed on practical applications, global regulatory standards, and ethical considerations in the healthcare industry.Section 1: IntroductionThis section introduces the foundational concepts of drug discovery and development. Topics include the approaches to drug discovery, clinical trial methodologies, and significant regulatory milestones such as the Food, Drug & Cosmetic Act and the lessons learned from the Thalidomide tragedy. These lectures set the stage for understanding the critical role of clinical research in drug safety and efficacy.Section 2: International Conference on Harmonization (ICH)Gain a comprehensive understanding of the International Conference on Harmonization (ICH), its history, and its impact on global regulatory standards. This section delves into the harmonization process, providing a framework for understanding how consistent regulatory practices ensure drug safety and quality worldwide.Section 3: Adverse Drug Reactions (ADRs)This section explores adverse drug reactions, their classifications, and mechanisms. Learners will develop skills to identify, analyze, and manage ADRs, ensuring patient safety and compliance with regulatory requirements.Section 4: Project Management in Clinical ResearchProject management is integral to clinical research success. This section covers project lifecycle stages, Schedule Y guidelines, and the responsibilities of clinical research teams. Learners will gain insights into effective project planning, execution, and documentation practices.Section 5: Clinical Research PhasesThis section examines the various phases of clinical research, from Phase 1 to Phase 4, with detailed discussions on CROs, ICH guidelines, and ICMR principles. Students will learn how each phase contributes to the drug approval process and post-market surveillance.Section 6: Regulatory Guidelines in Clinical ResearchUnderstanding Good Clinical Practice (GCP) is vital for clinical research. This section introduces the principles of GCP, ICH guidelines, and the process of writing Standard Operating Procedures (SOPs). It also includes a focus on MedWatch and Quality of Life (QOL) assessments.Section 7: PharmacovigilanceThis section introduces pharmacovigilance, emphasizing the importance of monitoring drug safety throughout its lifecycle. Topics include pharmacodynamics, pharmacokinetics, and clinical trial design, equipping students to manage safety concerns effectively.Section 8: Clinical Research Process: OutsourcingExplore the role of outsourcing in clinical research. This section highlights types of contracts, outsourcing processes, and best practices to ensure efficiency and regulatory compliance.Section 9: Fraud and Misconduct in Clinical ResearchFraud and misconduct undermine the integrity of clinical research. This section examines their prevalence, types, and preventive measures to ensure ethical practices in all stages of clinical research.Section 10: Special Trials: Bioequivalence and Bioavailability (BABE)Focused on bioequivalence studies, this section discusses the parameters of bioequivalence and FDA guidelines, preparing students for roles in specialized clinical trials.Section 11: Communication in Clinical ResearchEffective communication is crucial in clinical research. This section teaches the fundamentals of communication and its role in ensuring collaboration and compliance within research teams.Course Conclusion:By the end of the course, students will have a thorough understanding of clinical research processes, regulatory requirements, and pharmacovigilance. This knowledge will empower them to contribute meaningfully to drug development, safety monitoring, and regulatory compliance.

Overview

Section 1: Introduction

Lecture 1 New Drug Discovery

Lecture 2 Clinical Trial Therapy

Lecture 3 Food, Drug & Cosmetic Act

Lecture 4 Thalidomide tragedy

Lecture 5 Approaches to Drug Discovery

Lecture 6 Drug Development Stages

Section 2: International conference harmonization

Lecture 7 Intro ICF

Lecture 8 His of ICF part 1

Lecture 9 His of ICF part 2

Lecture 10 process of icf

Section 3: Adverse Drug Reaction

Lecture 11 Adverse Drug Reaction

Lecture 12 Casualty Classification

Lecture 13 Seriousness Classification

Lecture 14 Mechanism Classification

Section 4: Project management

Lecture 15 introduction to project management

Lecture 16 stages in project management Part-1

Lecture 17 stages in project management Part-2

Lecture 18 introduction to schedule y

Lecture 19 changes in schedule y

Lecture 20 responsibility and appendix Part-1

Lecture 21 responsibility and appendix Part-2

Lecture 22 responsibility and appendix Part-3

Section 5: Clinical Research Phases

Lecture 23 introduction to cro

Lecture 24 Phase 1 Part-1

Lecture 25 Phase 1 Part-2

Lecture 26 Phase 2

Lecture 27 phase3

Lecture 28 introduction ICH Part 1

Lecture 29 introduction ICH Part 2

Lecture 30 ich categories

Lecture 31 phase 4 intro

Lecture 32 types of phase 4

Lecture 33 intro ICMR

Lecture 34 principal of icmr

Section 6: Regulatory Guideline in Clinical research

Lecture 35 introduction to gcp

Lecture 36 section of ich gcp Part 1

Lecture 37 section of ich gcp Part 2

Lecture 38 introduction to sop

Lecture 39 writing sop Part 1

Lecture 40 writing sop Part 2

Lecture 41 introduction

Lecture 42 what where who to report

Lecture 43 medwatch

Lecture 44 QOL intro

Lecture 45 QOL in detail

Section 7: Pharmacovigilance

Lecture 46 introduction to pharmacology

Lecture 47 pharmacodynamics

Lecture 48 pharmacokinetics

Lecture 49 introduction to medical writing

Lecture 50 characteristics

Lecture 51 introduction to clinical trail design and biostats

Lecture 52 clinical trail design Part 1

Lecture 53 clinical trail design Part 2

Lecture 54 selection of design

Section 8: Clinical Research Process: outsourcing

Lecture 55 Outsourcing Introduction

Lecture 56 Types of Contract

Lecture 57 Outsourcing Process

Lecture 58 Outsourcing Process Continue

Section 9: Fraud and Misconduct

Lecture 59 Introduction Fraud and Misconduct

Lecture 60 Prevalence of Fraud

Section 10: Special Trail: BABE

Lecture 61 Introduction to Bio Equivalence Studies

Lecture 62 Parameters Bio Equivalence

Lecture 63 FDA Guideline

Section 11: Communication

Lecture 64 Definition Communication

Lecture 65 communication Skill in Clinical Research

Students and professionals aspiring to enter the clinical research field.,Healthcare professionals looking to expand their knowledge of regulatory practices.,Individuals interested in pharmacovigilance and drug safety monitoring.,Project managers and coordinators in clinical trials.