Mastering Regulatory Compliance: Ensuring Total Coverage for Pharmaceutical Marketing Professionals
This comprehensive course is designed to provide pharmaceutical marketing professionals with a thorough understanding of regulatory compliance, ensuring total coverage of all relevant topics. Participants will receive a certificate upon completion, issued by The Art of Service.Course Features - Interactive and engaging learning experience
- Comprehensive and personalized course content
- Up-to-date and practical information
- Real-world applications and case studies
- High-quality content developed by expert instructors
- Certificate issued by The Art of Service upon completion
- Flexible learning options, including mobile access
- User-friendly and community-driven platform
- Actionable insights and hands-on projects
- Bite-sized lessons and lifetime access
- Gamification and progress tracking features
Course Outline Chapter 1: Introduction to Regulatory Compliance
- Overview of regulatory compliance in the pharmaceutical industry
- Importance of compliance in pharmaceutical marketing
- Key regulatory agencies and their roles
- Consequences of non-compliance
Chapter 2: FDA Regulations and Guidelines
- Overview of FDA regulations and guidelines
- FDA's role in regulating pharmaceutical marketing
- Key FDA regulations and guidelines for pharmaceutical marketing
- FDA's enforcement actions and penalties for non-compliance
Chapter 3: PhRMA Code and OIG Guidelines
- Overview of the PhRMA Code and OIG guidelines
- Key principles and guidelines for pharmaceutical marketing
- Restrictions on gifts, entertainment, and other benefits
- Reporting and disclosure requirements
Chapter 4: Compliance with Anti-Kickback Statute and False Claims Act
- Overview of the Anti-Kickback Statute and False Claims Act
- Prohibited activities and exceptions
- Consequences of non-compliance
- Best practices for compliance
Chapter 5: Transparency and Disclosure Requirements
- Overview of transparency and disclosure requirements
- Reporting requirements for payments to healthcare professionals
- Disclosure requirements for clinical trial data
- Best practices for transparency and disclosure
Chapter 6: Compliance with HIPAA and Patient Data Protection
- Overview of HIPAA and patient data protection regulations
- Protected health information (PHI) and electronic protected health information (ePHI)
- Restrictions on use and disclosure of PHI and ePHI
- Consequences of non-compliance
Chapter 7: International Regulatory Compliance
- Overview of international regulatory compliance
- Key international regulations and guidelines
- Compliance with EU's General Data Protection Regulation (GDPR)
- Best practices for international regulatory compliance
Chapter 8: Auditing and Monitoring for Compliance
- Overview of auditing and monitoring for compliance
- Key components of a compliance audit program
- Best practices for auditing and monitoring
- Consequences of non-compliance
Chapter 9: Corrective Action and Remediation
- Overview of corrective action and remediation
- Key components of a corrective action plan
- Best practices for corrective action and remediation
- Consequences of non-compliance
Chapter 10: Training and Education for Compliance
- Overview of training and education for compliance
- Key components of a compliance training program
- Best practices for training and education
- Consequences of non-compliance
Chapter 11: Compliance and Risk Management
- Overview of compliance and risk management
- Key components of a compliance risk management program
- Best practices for compliance and risk management
- Consequences of non-compliance
Chapter 12: Future of Regulatory Compliance
- Overview of the future of regulatory compliance
- Emerging trends and technologies
- Best practices for staying ahead of the curve
- Consequences of non-compliance
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Chapter 1: Introduction to Regulatory Compliance
- Overview of regulatory compliance in the pharmaceutical industry
- Importance of compliance in pharmaceutical marketing
- Key regulatory agencies and their roles
- Consequences of non-compliance
Chapter 2: FDA Regulations and Guidelines
- Overview of FDA regulations and guidelines
- FDA's role in regulating pharmaceutical marketing
- Key FDA regulations and guidelines for pharmaceutical marketing
- FDA's enforcement actions and penalties for non-compliance
Chapter 3: PhRMA Code and OIG Guidelines
- Overview of the PhRMA Code and OIG guidelines
- Key principles and guidelines for pharmaceutical marketing
- Restrictions on gifts, entertainment, and other benefits
- Reporting and disclosure requirements
Chapter 4: Compliance with Anti-Kickback Statute and False Claims Act
- Overview of the Anti-Kickback Statute and False Claims Act
- Prohibited activities and exceptions
- Consequences of non-compliance
- Best practices for compliance
Chapter 5: Transparency and Disclosure Requirements
- Overview of transparency and disclosure requirements
- Reporting requirements for payments to healthcare professionals
- Disclosure requirements for clinical trial data
- Best practices for transparency and disclosure
Chapter 6: Compliance with HIPAA and Patient Data Protection
- Overview of HIPAA and patient data protection regulations
- Protected health information (PHI) and electronic protected health information (ePHI)
- Restrictions on use and disclosure of PHI and ePHI
- Consequences of non-compliance
Chapter 7: International Regulatory Compliance
- Overview of international regulatory compliance
- Key international regulations and guidelines
- Compliance with EU's General Data Protection Regulation (GDPR)
- Best practices for international regulatory compliance
Chapter 8: Auditing and Monitoring for Compliance
- Overview of auditing and monitoring for compliance
- Key components of a compliance audit program
- Best practices for auditing and monitoring
- Consequences of non-compliance
Chapter 9: Corrective Action and Remediation
- Overview of corrective action and remediation
- Key components of a corrective action plan
- Best practices for corrective action and remediation
- Consequences of non-compliance
Chapter 10: Training and Education for Compliance
- Overview of training and education for compliance
- Key components of a compliance training program
- Best practices for training and education
- Consequences of non-compliance
Chapter 11: Compliance and Risk Management
- Overview of compliance and risk management
- Key components of a compliance risk management program
- Best practices for compliance and risk management
- Consequences of non-compliance
Chapter 12: Future of Regulatory Compliance
- Overview of the future of regulatory compliance
- Emerging trends and technologies
- Best practices for staying ahead of the curve
- Consequences of non-compliance