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Drug Development and Clinical Research · LearnSpace
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Drug Development and Clinical Research

Курс от EDUCBA
Уровень не указан≈ 17.9 чАнглийский
О курсеНавыкиПрограммаПреподаватели

О курсе

Master Clinical Research, Drug Development, and ICH-GCP with real-world insights. Build industry-ready skills to launch your career in clinical trials and pharma. This comprehensive Clinical Research Training course is designed to help learners understand the complete lifecycle of drug development—from discovery to post-marketing surveillance. You will explore clinical trial phases, regulatory frameworks such as ICH-GCP and Schedule Y, and essential concepts like informed consent, pharmacovigilance, and bioequivalence studies. The course emphasizes practical, industry-relevant skills including SOP writing, clinical documentation, outsourcing processes, and communication in research environments. Through structured modules, learners will gain the ability to analyze clinical trial designs, understand ethical guidelines, and apply regulatory standards in real-world scenarios. Whether you are a student, graduate, or professional looking to enter the pharmaceutical or clinical research industry, this course equips you with the knowledge and confidence needed to succeed in roles such as Clinical Research Associate (CRA), Clinical Trial Coordinator (CTC), and Pharmacovigilance Associate.

Навыки, которые вы освоите

Clinical TrialsInformed ConsentGood Clinical Practices (GCP)Clinical ResearchDrug DevelopmentPharmacologyPre-Clinical DevelopmentBiostatisticsCommunicationClinical Research EthicsClinical MonitoringClinical Research CoordinationClinical Data ManagementMarketingPharmaceuticalsResearchInstitutional Review Board (IRB)Technical WritingPatient SafetyClinical Documentation

Программа курса

7 модулей · 96 учебных материалов

01Drug Discovery & Regulatory Foundations15 материалов

Introduction to Drug Development

New Drug DiscoveryВидеоClinical Trial TherapyВидеоFood,Drug & Cosmetic ActВидеоIntroduction to Drug DevelopmentЗадание

Historical Insights & Development Process

Учитесь у экспертов

EDUCBA

Преподаватель курса

Drug Development and Clinical Research
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Обучение на Coursera

≈ 17.9 ч

7 модулей

Язык: Английский

Часть программы вашего университета
Thalidomide tragedyВидео
Approaches to Drug DiscoveryВидео
Drug Development StagesВидео
Historical Insights & Development ProcessЗадание

Introduction to Informed Consent

Intro ICFВидеоICF History OverviewВидеоICF Evolution & Key MilestonesВидеоIntroduction to Informed ConsentЗаданиеApplying Drug Development & Informed Consent in Clinical ScenariosDIALOGUEDrug Discovery & Regulatory FoundationsЗаданиеEvaluating Drug Readiness and Ensuring Ethical Clinical Trial InitiationDIALOGUE
02Informed Consent & Drug Safety13 материалов

ICF Process & Safety Basics

process of icfВидеоAdverse Drug ReactionВидеоCasualty ClassificationВидеоICF Process & Safety BasicsЗадание

Safety Evaluation Methods

Seriousness ClassificationВидеоMechanism ClassificationВидеоintroduction to project managementВидеоSafety Evaluation MethodsЗадание

Project Management Overview

Project Management Stages (Basics)ВидеоProject Management Stages (Advanced)Видеоintroduction to schedule yВидеоProject Management in Clinical ResearchЗаданиеInformed Consent & Drug SafetyЗадание
03Clinical Operations & Trial Phases13 материалов

Regulatory Updates & Roles

changes in schedule yВидеоRoles & Responsibilities (Intro)ВидеоRoles & Responsibilities (Details)ВидеоRegulatory Updates & RolesЗадание

Documentation & CRO

Appendix & DocumentationВидеоintroduction to croВидеоPhase I Trials (Overview)ВидеоDocumentation & CROЗадание

Clinical Trial Progression

Phase I Trials (Process)ВидеоPhase 2Видеоphase3ВидеоClinical Trial ProgressionЗаданиеClinical Operations & Trial PhasesЗадание
04Global Guidelines & Ethics13 материалов

ICH Guidelines

ICH Guidelines IntroductionВидеоICH Framework & ScopeВидеоich categoriesВидеоICH GuidelinesЗадание

Advanced Trial Phases

phase 4 introВидеоtypes of phase 4Видеоintro ICMRВидеоAdvanced Trial PhasesЗадание

Ethical & GCP Standards

principal of icmrВидеоintroduction to gcpВидеоICH-GCP Sections OverviewВидеоEthical & GCP StandardsЗаданиеGlobal Guidelines & EthicsЗадание
05SOPs & Reporting Systems13 материалов

SOP & GCP Implementation

ICH-GCP Detailed SectionsВидеоintroduction to sopВидеоSOP Writing BasicsВидеоGCP & SOP FundamentalsЗадание

Reporting Framework

SOP Writing ProcessВидеоintroductionВидеоwhat where who to reportВидеоSOP Implementation & ReportingЗадание

Pharmacovigilance & QOL

medwatchВидеоQOL introВидеоQOL in detailВидеоPharmacovigilance & QOLЗаданиеSOPs & Reporting SystemsЗадание
06Pharmacology & Trial Design13 материалов

Pharmacology Fundamentals

introduction to pharmacologyВидеоpharmacodynamicsВидеоpharmacokineticsВидеоPharmacology FundamentalsЗадание

Medical Writing & Biostatistics

introduction to medical writingВидеоcharacteristicsВидеоintroduction to clinical trail design and biostatsВидео Medical Writing & BiostatisticsЗадание

Clinical Trial Design

Clinical Trial Design BasicsВидеоClinical Trial Design MethodsВидеоselection of designВидеоClinical Trial DesignЗаданиеPharmacology & Trial DesignЗадание
07Outsourcing, Compliance & Communication16 материалов

Outsourcing Concepts

Outsourcing IntroductionВидеоTypes of ContractВидеоOutsourcing ProcessВидеоOutsourcing in Clinical ResearchЗадание

Risk & Compliance

Outsourcing Process ContinueВидеоIntroduction Fraud and MisconductВидеоPrevalence of FraudВидеоRisk, Fraud & BioequivalenceЗадание

Bioequivalence & Communication Skills

Introduction to Bio Equivalence StudiesВидеоParameters Bio EquivalenceВидеоFDA GuidelineВидеоDefinition CommunicationВидеоcommunication Skill in Clinical ResearchВидеоBioequivalence & Communication SkillsЗадание
Outsourcing, Compliance & CommunicationЗадание
Managing a Clinical Trial: From Drug Discovery to Ethical ApprovalDIALOGUE