Regulatory Affairs in Clinical Research Management
( 25 Modules )

Module #1
Introduction to Regulatory Affairs
Overview of the regulatory landscape in clinical research, importance of regulatory affairs, and roles and responsibilities

Module #2
Regulatory Frameworks and Guidelines
International regulations and guidelines governing clinical research, including ICH, FDA, and EU regulations

Module #3
Good Clinical Practice (GCP)
Principles and guidelines of GCP, including investigator responsibilities, informed consent, and data quality

Module #4
Clinical Trial Registration and Results Reporting
Overview of clinical trial registration and results reporting, including ClinicalTrials.gov and EudraCT

Module #5
Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs)
Roles and responsibilities of IRBs and IECs, including ethical review of clinical trials

Module #6
Informed Consent and Patient Recruitment
Ethical and regulatory considerations for informed consent, including patient recruitment and retention strategies

Module #7
Investigational Product (IP) Management
Regulatory requirements and best practices for IP management, including labeling, storage, and accountability

Module #8
Clinical Trial Agreements (CTAs) and Contracts
Negotiation and management of CTAs and contracts, including budgeting and financial considerations

Module #9
Regulatory Submissions and Approvals
Preparing and submitting regulatory applications, including IND, NDA, and EMA submissions

Module #10
Clinical Trial Monitoring and Auditing
Regulatory requirements and best practices for on-site and remote monitoring, auditing, and quality control

Module #11
Adverse Event Reporting and Pharmacovigilance
Regulatory requirements and best practices for adverse event reporting, including MedWatch and EudraVigilance

Module #12
Data Management and Biostatistics
Regulatory requirements and best practices for data management, including data cleaning, validation, and statistical analysis

Module #13
Risk-Based Monitoring and Quality Management
Implementing risk-based monitoring and quality management systems to ensure compliance and data quality

Module #14
Regulatory Inspections and Compliance
Preparing for and managing regulatory inspections, including FDA and EMA inspections

Module #15
Post-Marketing Surveillance and Risk Management
Regulatory requirements and best practices for post-marketing surveillance and risk management

Module #16
Regulatory Affairs in Emerging Markets
Challenges and opportunities in regulatory affairs in emerging markets, including China, India, and Brazil

Module #17
Electronic Systems and Technology in Regulatory Affairs
Using electronic systems and technology to streamline regulatory affairs, including eCTD and XML

Module #18
Regulatory Writing and Publishing
Regulatory writing and publishing best practices, including clinical trial reports and manuscript preparation

Module #19
Regulatory Affairs in Gene and Cell Therapy
Specialized regulatory considerations for gene and cell therapy products, including CBER and EMA guidelines

Module #20
Regulatory Affairs in Medical Devices
Regulatory requirements and best practices for medical devices, including FDA and EU MDR guidelines

Module #21
Regulatory Affairs in Biotechnology
Regulatory considerations for biotechnology products, including CBER and EMA guidelines

Module #22
Regulatory Affairs in Pediatrics and Rare Diseases
Specialized regulatory considerations for pediatric and rare disease clinical trials, including FDA and EMA guidelines

Module #23
Regulatory Affairs in Clinical Research Site Management
Regulatory considerations for clinical research site management, including site selection and management

Module #24
Regulatory Affairs in Outsourcing and Vendor Management
Regulatory considerations for outsourcing and vendor management, including CRO and vendor selection

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Affairs in Clinical Research Management career

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Regulatory Affairs in Clinical Research Management ( 25 Modules )

Regulatory Affairs in Clinical Research Management
( 25 Modules )