Drug Development and Clinical Trials
( 25 Modules )

Module #1
Introduction to Drug Development
Overview of the drug development process, importance of clinical trials, and regulatory framework

Module #2
Regulatory Framework for Drug Development
FDA regulations, ICH guidelines, and EU directives governing drug development and clinical trials

Module #3
Pharmacology and Pharmacokinetics
Principles of pharmacology and pharmacokinetics, drug absorption, distribution, metabolism, and excretion (ADME)

Module #4
Preclinical Development
In vitro and in vivo studies, animal models, and IND-enabling studies

Module #5
Investigational New Drug (IND) Application
Preparation and submission of an IND application to the FDA

Module #6
Phase I Clinical Trials
First-in-human studies, safety and tolerability assessment, and pharmacokinetic studies

Module #7
Phase II Clinical Trials
Proof-of-concept studies, dose-response relationships, and efficacy evaluation

Module #8
Phase III Clinical Trials
Pivotal studies, efficacy and safety confirmation, and regulatory submission

Module #9
Clinical Trial Design and Methodology
Randomization, blinding, placebo controls, and statistical considerations

Module #10
Good Clinical Practice (GCP) and Clinical Trial Operations
GCP principles, site selection, and trial management

Module #11
Data Management and Biostatistics
Data collection, cleaning, and analysis, biostatistical methods and principles

Module #12
Safety Monitoring and Pharmacovigilance
Adverse event reporting, safety monitoring committees, and pharmacovigilance regulations

Module #13
Regulatory Submissions and Approvals
NDA, BLA, and MAA submissions, FDA review process, and post-approval regulations

Module #14
Drug Product Development and Manufacturing
Formulation, pharmaceutical development, and GMP regulations

Module #15
Packaging and Labeling
Packaging design, labeling regulations, and patient compliance

Module #16
Quality Control and Assurance
Quality control testing, validation, and assurance protocols

Module #17
Global Clinical Trials and Regulatory Harmonization
International clinical trials, regulatory harmonization, and differences in global regulations

Module #18
Ethics and Informed Consent
Ethical principles, informed consent, and vulnerable populations

Module #19
Risk Management and Crisis Communication
Risk management, crisis communication, and product recalls

Module #20
Pediatric and Orphan Diseases Clinical Trials
Unique challenges and considerations for pediatric and orphan disease clinical trials

Module #21
Personalized Medicine and Biomarkers
Personalized medicine, biomarkers, and companion diagnostics

Module #22
Immunotherapy and Gene Therapy Clinical Trials
Unique challenges and considerations for immunotherapy and gene therapy clinical trials

Module #23
Real-World Evidence and Observational Studies
Real-world evidence, observational studies, and post-marketing surveillance

Module #24
Digital Health and Clinical Trials
Digital health technologies, decentralized trials, and remote monitoring

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Drug Development and Clinical Trials career

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Drug Development and Clinical Trials ( 25 Modules )

Drug Development and Clinical Trials
( 25 Modules )