Regulatory and Compliance Issues in Digital Therapeutics
( 30 Modules )

Module #1
Introduction to Digital Therapeutics
Definition, history, and current state of digital therapeutics

Module #2
Regulatory Landscape Overview
FDA, EMA, and other global regulatory agencies roles in digital therapeutics

Module #3
Compliance Fundamentals
Key principles and concepts in regulatory compliance for digital therapeutics

Module #4
Digital Health vs. Digital Therapeutics
Distinguishing between digital health and digital therapeutics from a regulatory perspective

Module #5
Market Trends and Growth
Current market trends, growth projections, and implications for regulatory compliance

Module #6
FDA Classification of Digital Therapeutics
FDA classification of digital therapeutics as devices, drugs, or biologics

Module #7
Pre-Market Review and Clearance
FDA pre-market review process for digital therapeutics

Module #8
Post-Market Surveillance and Vigilance
FDA post-market surveillance and vigilance requirements for digital therapeutics

Module #9
Software as a Medical Device (SaMD)
FDA regulations for software as a medical device (SaMD) in digital therapeutics

Module #10
Digital Therapeutics and Combination Products
FDA regulations for combination products in digital therapeutics

Module #11
EU Medical Device Regulation (MDR)
EU MDR and its implications for digital therapeutics

Module #12
CE Marking for Digital Therapeutics
CE marking requirements for digital therapeutics in the EU

Module #13
International Classification of Diseases (ICD)
ICD coding and its impact on digital therapeutics

Module #14
Regulations in Asia-Pacific Region
Overview of regulations in key Asia-Pacific countries

Module #15
Global Harmonization Initiatives
International initiatives for harmonizing regulations in digital therapeutics

Module #16
HIPAA and GDPR in Digital Therapeutics
Data privacy and security regulations in the US and EU

Module #17
Data Protection and Anonymization
Best practices for data protection and anonymization in digital therapeutics

Module #18
Cybersecurity Threats and Risk Management
Cybersecurity risks and mitigation strategies for digital therapeutics

Module #19
Data Sharing and Interoperability
Regulatory considerations for data sharing and interoperability in digital therapeutics

Module #20
Cloud Computing and Data Storage
Regulatory considerations for cloud computing and data storage in digital therapeutics

Module #21
Clinical Trial Design for Digital Therapeutics
Designing clinical trials for digital therapeutics

Module #22
Outcome Measures and Endpoints
Selecting suitable outcome measures and endpoints for digital therapeutics

Module #23
Validation and Verification of Digital Therapeutics
Validation and verification methodologies for digital therapeutics

Module #24
Real-World Evidence and Post-Market Studies
Using real-world evidence and post-market studies to support digital therapeutic development

Module #25
Lessons Learned from Recent Clinical Trials
Case studies of successful and failed clinical trials in digital therapeutics

Module #26
AI and Machine Learning in Digital Therapeutics
Regulatory considerations for AI and machine learning in digital therapeutics

Module #27
Wearable Devices and mHealth
Regulatory considerations for wearable devices and mHealth in digital therapeutics

Module #28
Personalized Medicine and Digital Therapeutics
Opportunities and challenges in personalized medicine and digital therapeutics

Module #29
Global Regulatory Harmonization Initiatives
International efforts to harmonize regulations in digital therapeutics

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Regulatory and Compliance Issues in Digital Therapeutics career

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