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Mastering Compliance; A Step-by-Step Guide to Pharmaceutical Marketing Regulations and Risk Management

Mastering Compliance; A Step-by-Step Guide to Pharmaceutical Marketing Regulations and Risk Management

$199.00
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Mastering Compliance: A Step-by-Step Guide to Pharmaceutical Marketing Regulations and Risk Management



Course Overview

This comprehensive course is designed to provide pharmaceutical professionals with a thorough understanding of marketing regulations and risk management strategies. Participants will learn how to navigate the complex regulatory landscape, ensure compliance, and mitigate risks associated with pharmaceutical marketing.



Course Objectives

  • Understand the regulatory framework governing pharmaceutical marketing
  • Identify potential risks and develop strategies for mitigation
  • Develop a comprehensive compliance program
  • Ensure adherence to industry standards and best practices
  • Enhance knowledge of pharmaceutical marketing regulations and risk management


Course Outline

Module 1: Introduction to Pharmaceutical Marketing Regulations

  • Overview of pharmaceutical marketing regulations
  • Regulatory framework: FDA, PhRMA, and international regulations
  • Industry standards and best practices
  • Consequences of non-compliance

Module 2: Understanding Pharmaceutical Marketing Laws and Regulations

  • FDA regulations: 21 CFR Part 202 and 21 CFR Part 203
  • PhRMA Code on Interactions with Healthcare Professionals
  • International regulations: EU, Canada, and Australia
  • State and local regulations

Module 3: Risk Management Strategies

  • Identifying potential risks in pharmaceutical marketing
  • Risk assessment and mitigation strategies
  • Developing a risk management plan
  • Monitoring and evaluating risk management efforts

Module 4: Compliance Program Development

  • Elements of a comprehensive compliance program
  • Establishing policies and procedures
  • Training and education
  • Auditing and monitoring
  • Corrective action and remediation

Module 5: Ensuring Adherence to Industry Standards and Best Practices

  • Industry standards: PhRMA, AdvaMed, and BIO
  • Best practices: transparency, disclosure, and accountability
  • Ensuring adherence to industry standards and best practices
  • Consequences of non-adherence

Module 6: Pharmaceutical Marketing Regulations and Social Media

  • Regulatory framework: FDA guidance on social media
  • Industry standards and best practices for social media
  • Risk management strategies for social media
  • Monitoring and evaluating social media activities

Module 7: International Pharmaceutical Marketing Regulations

  • EU regulations: EFPIA and EU Directive 2001/83/EC
  • Canadian regulations: PAAB and Health Canada
  • Australian regulations: Medicines Australia and TGA
  • Other international regulations

Module 8: Advanced Topics in Pharmaceutical Marketing Regulations

  • Off-label promotion and the First Amendment
  • Medical device regulations: FDA and international
  • Clinical trial regulations: FDA and international
  • Pharmaceutical marketing regulations and the opioid crisis

Module 9: Case Studies and Group Discussions

  • Real-world examples of pharmaceutical marketing regulations and risk management
  • Group discussions and problem-solving exercises
  • Applying knowledge and skills to real-world scenarios

Module 10: Final Project and Course Wrap-Up

  • Final project: developing a comprehensive compliance program
  • Course review and wrap-up
  • Q&A and final thoughts


Course Features

  • Interactive and engaging: Quizzes, games, and interactive exercises to keep you engaged and motivated
  • Comprehensive and up-to-date: Covering the latest regulations, industry standards, and best practices
  • Personalized learning: Tailor the course to your needs and interests
  • Practical and real-world applications: Case studies and group discussions to apply knowledge and skills
  • High-quality content: Developed by expert instructors with extensive experience in pharmaceutical marketing regulations and risk management
  • Certification: Receive a certificate upon completion, issued by The Art of Service
  • Flexible learning: Access the course anytime, anywhere, on any device
  • User-friendly: Easy-to-use interface and clear navigation
  • Mobile-accessible: Access the course on your mobile device
  • Community-driven: Join a community of professionals and stay connected
  • Actionable insights: Take away practical knowledge and skills to apply in your job
  • Hands-on projects: Develop a comprehensive compliance program and apply knowledge and skills
  • Bite-sized lessons: Learn in manageable chunks, at your own pace
  • Lifetime access: Access the course materials forever
  • Gamification: Earn points, badges, and rewards for completing modules and achieving milestones
  • Progress tracking: Track your progress and stay motivated


Certificate of Completion

Upon completing the course, participants will receive a Certificate of Completion, issued by The Art of Service. This certificate demonstrates your knowledge and skills in pharmaceutical marketing regulations and risk management, and can be used to enhance your career prospects and professional development.

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