Prevention of Falsified Medicinal Products

Description

Prevention of Falsified Medicinal Products

This course will help you and your colleagues understand what’s needed to prevent counterfeit drugs, substandard medicines, and fake medical devices from entering the market, including preventing misbranded and falsely labelled medicinal products.

Course Overview

The World Health Organisation estimates that countries inadvertently spend ~ $30 billion US annually on counterfeit medicines (falsified medicinal products) and substandard drug products. In low-income and developing countries, counterfeits and substandard drug products make up an estimated 10% of the medicine supply chain.

With counterfeit medicines entering supply chains across the globe, including infiltrating highly developed countries in growing numbers, regulators require manufacturers to implement proactive and robust prevention measures for the prevention of falsified (counterfeits) and substandard medicines from entering supply chains. This course will help you understand the steps manufacturers must take to remain in compliance with counterfeit drug prevention laws, and to ensure a robust approach to the prevention of falsified medicines.

Why complete this Course?

• This online GMP course discusses regulations covering the Prevention of Falsified Medicinal Products.
• It is designed for pharmaceutical and medical device manufacturing and distribution personnel, including hospital workers, doctors, veterinary practitioners, and independent pharmacists.

Benefits of course completion:

• Gain a comprehensive understanding of regulatory requirements and industry best practices for preventing falsified medicinal products.
• Explore key legislation, supply chain vulnerabilities, and protective measures to mitigate risks associated with fake medicines, counterfeit drugs and adulterated medicines.

Key Learning Topics

• Understanding counterfeit medicines and substandard drug products
• Supply chain vulnerabilities and risk mitigation strategies
• Global legislative requirements for counterfeit drug prevention
• Regulatory compliance, pharmacovigilance, and post-market surveillance
• Industry standards including GMP, GDP, and GWP for safeguarding medicines
• Best practices for serialization, track-and-trace systems, and secure distribution

Who Should Complete this Course?

This course is ideal for professionals involved in pharmaceutical manufacturing, distribution, and regulatory compliance, including:

✅ Management teams
✅ Production-line personnel
✅ Operations Managers
✅ Warehouse personnel; packaging and labelling personnel
✅ Distribution personnel and logistics service providers
✅ Qualified Persons (QPs) and Quality Team Members
✅ Transportation personnel including drivers and cargo handlers
✅ Laboratory personnel
✅ Responsible Persons (RPs)
✅ Wholesalers, hospitals, and healthcare institutions
✅ GMP compliance inspectors
✅ Regulatory affairs personnel

Regulatory Requirements for Preventing Falsified Medicines

This course will help you understand the essential requirements and quality control systems for the prevention of falsified medicinal products. This course includes examples from key regulatory authorities and other government agencies, e.g.:

📌WHO IMPACT & Interpol operations on counterfeit drug prevention
📌US FDA regulations (Title 21 CFR) for packaging, labelling, and serialization
📌EU EMA guidance on falsified medicine prevention and distribution safeguards
📌Australian TGA regulatory requirements for counterfeit drug prevention
📌Best practices for securing supply chains and mitigating counterfeit risks

Counterfeit Drug Prevention Case Studies and Regulatory Insights

✅ Case studies highlighting risks in medicine supply chains
✅ Regulatory enforcement trends and best practices for compliance
✅ Real-world examples of counterfeiting incidents and prevention strategies

Flexible Online Learning Format

This self-paced eLearning course allows participants to:
✔️ Access course materials anytime, anywhere (valid for 12 months from the date of purchase)
✔️ Learn at their own pace with real-world case studies & regulatory insights
✔️ Combine online learning with instructor-led training options (virtual or onsite, where available)

Prevention of Falsified Medicines GMP Training Certificate

Upon successful completion of the Final Assessment of this online GMP course, you will earn a Prevention of Falsified Medicines (GMP) Training Certificate of Completion. This GMP Training Certificate can be used to demonstrate compliance training in this topic.

The GMP Certificate of Completion (GMP Training Certificate):

• Should be added to your personnel records and your company’s GMP Training Program files
• Can be attached to current job applications and job-change/promotion requests
• Helps validate your GMP education and your knowledge of counterfeit drug prevention requirements
• Supports career development in pharmaceutical regulatory compliance & medical device regulatory compliance

It is recommended to review relevant GMP regulations AFTER completing the course. Best practice eLearning is to review the guidelines, then complete this course, and then re-read the guidelines and regulations on this topic. Doing so will aid your GMP compliance knowledge and improve your retention of the course information.

Resources & Additional GMP eLearning Courses

Explore additional GMP training courses, including:

• Good Distribution Practice (GDP) & Good Warehouse Practice (GWP)
• Pharmacovigilance & Post-Marketing Surveillance
• Serialization, Unique Product Identifiers, and Track-and-Trace Systems
• 70+ GMP education modules for compliance training

Click here to explore more GMP eLearning courses!

Further reading

World Health Organisation articles on falsified medical products and counterfeit drugs

UNODC Policy & Legislative Recommendations to combat counterfeit medicines/falsified medicinal products