Combating Counterfeit Medicines: Insights from Global QPPV

In the fight against counterfeit medicines, the stakes are incredibly high. Counterfeit drugs pose significant threats to public health worldwide, with far-reaching consequences, especially in regions with limited regulatory oversight. At Navitas Life Sciences, we are dedicated to addressing these challenges head-on. Recently, Dr. Philipp Hofmann, our Director of Pharmacovigilance and Qualified Person for Pharmacovigilance (QPPV), authored an insightful article on this critical issue, shedding light on the pervasive problem of counterfeit drugs and the crucial role of pharmacovigilance (PV) in combating this menace.

Navitas Life Sciences’ Comprehensive QPPV Services

With over 30 years of experience in pharmacovigilance services, we bring unparalleled expertise and robust infrastructure to support your business. We prioritize patient safety and regulatory compliance, ensuring that you are always in capable hands.

Our End-to-End QPPV Services Include:

We offer comprehensive QPPV services, including EU QPPV services, that ensure the safety, efficacy, and quality of medicines.

• Availability of QPPV and Local QPPV : We provide QPPV and local QPPV with appropriate backups for the EU and the UK, adhering to local Health Authority (HA) requirements. Our network of local QPPV broadens our global presence.
• 24/7 Point of Contact : Our team is available around the clock to serve as a point of contact for Competent Authorities. This includes backup QPPV support for the EU and other regions as needed.
• Preparation, Maintenance, and Review of PSMF : We handle the preparation, maintenance, and review of the Pharmacovigilance System Master File (PSMF), ensuring that all documentation is accurate and up to date.
• Ongoing Monitoring of Local Safety Parameters : Our services include continuous monitoring of local safety parameters, encompassing Aggregate Reports, signal detection, and the assessment of the benefit-risk profile of Marketing Authorization Holder (MAH) products.

By leveraging our comprehensive QPPV services, you can ensure your business remains compliant and your patients remain safe. QPPV roles and responsibilities could range from a few hours per month and additional hours of QPPV consulting, to a full QPPV office with a QPPV, deputy QPPV, and administrational support. The activities of the QPPV office are based on your portfolio and geography, with customizable solutions based on your specific needs.

Dr Philipp Hofmann

Director of Pharmacovigilance & Global QPPV,

Navitas Life Sciences

To gain deeper insights into the challenges of combating counterfeit medicines and the role of pharmacovigilance, we had the privilege of interviewing our Pharmacovigilance specialist, Dr Philipp Hofmann, Director of Pharmacovigilance & Global QPPV.

Here are some excerpts from our conversation:

Dr Hofmann, what inspired you to focus on the issue of counterfeit medicines?

Many topics in pharmacovigilance are covered by regular PV activities, but counterfeit drugs are a global problem, which all company can face from small biotech to big pharma.

Can you explain how pharmacovigilance systems help detect counterfeit medicines?

Pharmacovigilance systems help detect counterfeit medicines by monitoring and analyzing reports of adverse drug reactions and medication errors. When unusual patterns or unexpected adverse effects are detected, they can indicate the presence of counterfeit drugs. These systems collect data from healthcare professionals, patients, and pharmaceutical companies, enabling the identification of inconsistencies in drug efficacy and safety profiles.

What are some of the biggest challenges in combating counterfeit medicines globally?

The biggest challenges in combating counterfeit medicines include weak regulatory frameworks, insufficient enforcement, complex supply chains, lack of public awareness, and sophisticated counterfeiting techniques. Additionally, limited resources for monitoring and verification, especially in low-income regions, hinder effective detection and prevention efforts, making it difficult to ensure drug authenticity.

How can healthcare professionals and patients contribute to the fight against counterfeit medicines?

Healthcare professionals can report suspicious drugs and adverse reactions to regulatory authorities, educate patients about identifying counterfeit medications, and only source drugs from reputable suppliers. Patients can contribute by purchasing medicines from licensed pharmacies, verifying drug authenticity using available tools (e.g., verification codes), and promptly reporting any unusual side effects or discrepancies in drug packaging.

What role does technology play in enhancing pharmacovigilance efforts against counterfeit drugs?

Technology enhances pharmacovigilance against counterfeit drugs by enabling real-time monitoring, data analytics, and possibilities for secure supply chain tracking. It supports advanced reporting systems and mobile verification apps for instance in pharmacies to detect and analyze suspicious drug-related activities efficiently.

The Crucial Role of Pharmacovigilance in Combatting Counterfeit Drugs

Dr Philipp Hofmann

Director of Pharmacovigilance & Global QPPV

Read Now

Published by pharmiweb.com - May 10^th 2024

The fight against counterfeit medicines is a critical battle that requires concerted efforts from all stakeholders involved. Dr Philipp Hofmann's article highlights the severe consequences of counterfeit drugs and the essential role of pharmacovigilance in mitigating these risks. At Navitas Life Sciences, we are committed to ensuring the safety, efficacy, and quality of medicines through our comprehensive QPPV and pharmacovigilance services.

As a leading pharmacovigilance CRO, offering tailor made pharmacovigilance services, including specialized pharmacovigilance consultancy, we leverage advanced technologies, understanding of regulatory authorities’ requirements, and well established local QPPVs to meet specific PV needs.

Among the top pharmacovigilance companies and pharmacovigilance CROs, Navitas Life Sciences stands out by offering unique pharmacovigilance services that ensure compliance and patient safety. Through our dedicated team of pharmacovigilance specialists, we continue to strive against counterfeit medicines and work towards a safer, healthier world.

To learn more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.