Latest Pharmacovigilance Updates in Germany

The pharmaceutical industry is undergoing constant reshaping with automation, cognitive intelligence, and other technological advancements being developed to ensure patient safety. Pharmacovigilance plays a crucial role in identifying, assessing, and preventing adverse effects of medications. At, Navitas Life Sciences, our comprehensive Pharmacovigilance support, including Qualified Person for Pharmacovigilance (QPPV) services, help pharmaceutical companies comply with global regulatory requirements while maintaining the highest standards of drug safety.

In this blog, we will explore the significance of QPPV services and get insights about the latest in pharmacovigilance in Germany, from Dr Philipp Hofmann, Director - Pharmacovigilance & QPPV.

Dr Philipp Hofmann

Director,

Pharmacovigilance & QPPV

Dr Hofmann, could you please translate and provide insights from the latest information available in the Pharmacovigilance Department of the BfArM?

For all medicinal products with the requirement of training materials on a specific active substance or a combination of active substances, the training material should be uniform and harmonised - both in terms of text and basic layout (GMP Module XVI, see in particular sections XVI.B.5. “Coordination” and XVI.C.1 .3. “Competent authorities in Member States”

It is therefore often necessary, especially close to patent expiry of the originator, to prepare uniform, generic and harmonised material and to make it available by the competent authority, for instance the German BfArM.

The preparation of the harmonised material is usually done in cooperation between the originator or a generic applicant and the BfArM. The BfArM then makes these harmonised training materials, available to the public on the Internet. The BfArM also coordinates any necessary updates of training material, e.g. because the originator has changed his training material.

Since the submission of training material is a prerequisite for placing the product on the market, there are often enquiries from applicants regarding the existence of harmonised material. The new platform on BfArM’s homepage is now intended to inform pharmaceutical companies with ongoing marketing authorisation procedures about the current status with the requirement of training material, and also to make harmonised material or material released by the originator available to generic companies there. This ensures timely information on ongoing harmonisation procedures and individual enquiries can largely be answered by research at this point.

This new platform on the homepage of BfArM provides all necessary information on training material as part of risk minimization measure in Pharmacovigilance to generic pharmaceutical companies with an existing authorisation or in the process of a marketing authorisation application.

The translated text is as follows:

As an expert in pharmacovigilance, what advice would you give to aspiring professionals? What skills and training would they require for pharmacovigilance jobs?

In Pharmacovigilance, we need candidates from a life sciences background. That could be physicians, pharmacists or people from the scientific world like biologists. In the case processing arena, it is a task to write and review serious adverse effects reports and forms; that needs high attention to details. The ability to communicate effectively with a wide range of people is also important, as interaction with the data entry person, reviewer or medical advisor is essential in case processing. In the further career in PV, a systematic approach to tasks and project management skills are needed to deal with several clients and to manage the workload in diverse projects, as well as setting up and reviewing processes and training to ensure compliance with legal obligations.

Your recent article in ACT has been well-received. Could you share the salient features and key takeaways from that article with our readers?

The article highlights the significant impact of adverse drug reactions (ADRs) on both individuals and society, leading to illness, fatalities, increased healthcare costs, and diminished well-being. It emphasizes the responsibility of healthcare professionals, such as doctors and pharmacists, to report ADRs to relevant drug commissions dedicated to their respective professions. Readers can gain insights into various essential aspects of ADR reporting, including strategies for identification and reporting, the obligation to report ADRs during the COVID-19 pandemic in Germany, the use of a Europe-wide database for ADR analysis, and the potential benefits of utilizing artificial intelligence for improved risk assessment. This comprehensive resource equips healthcare practitioners and stakeholders with valuable knowledge to enhance pharmacovigilance practices and ensure better patient safety.

Spontaneous Reporting System for Adverse Drug Reactions in Germany

The article delves into how adverse drug reactions (ADRs) pose a substantial health concern for individuals and society due to their role in causing illness and death, incurring significant healthcare expenses, and negatively affecting the well-being of those affected. It also explores how doctors and pharmacists have a professional duty to report ADRs to their respective drug commissions, specifically designated for physicians or pharmacists.

Download the article and get insights on

• Identifying ADRs and building reporting strategies
• COVID-19 and the obligation to report ADRs in Germany
• Utilizing a Europe-wide database for ADR
• Utilizing AI for better risk assessment

Read Now

Dr Philipp Hofmann

Director - Pharmacovigilance & QPPV

Navitas Life Sciences

Published by Applied Clinical Trials - July 2023

QPPV Support at Navitas Life Sciences

As a pharmacovigilance CRO, Navitas Life Sciences is committed to ensuring patient safety. Several key roles describe QPPV services at Navitas Life Sciences:

1. Focus on PV and Establishing a PV System in the EU:

Navitas places a primary focus on pharmacovigilance, recognizing its critical role in safeguarding patient safety. We help clients establish and maintain robust pharmacovigilance systems in compliance with EU regulations.

2. Safety First - Monitoring Drug Product Safety:

Navitas Life Sciences prioritizes patient safety by closely monitoring the safety profile of the drug products of the Marketing Authorization Holder (MAH).

3. Adherence to Legislation and Local Regulations:

Navitas understands that pharmacovigilance requirements can vary from one region to another. As a result, we coordinate actions based on local legislations. This proactive approach ensures that our clients remain compliant with regional and national pharmacovigilance regulations, avoiding any potential legal or reputational repercussions.

4. Single Point of Contact for Competent Authorities:

Our QPPV takes on the crucial role of being the single point of contact for Competent Authorities. Our QPPV services are available 24/7, enabling swift communication with regulatory authorities when necessary. This ensures a streamlined and efficient exchange of safety information, further enhancing client compliance and credibility.

5. Audits and Inspections Monitoring and Compliance:

Through regular audits and inspections, we monitor compliance with relevant regulations. This proactive approach helps identify areas of improvement and strengthens clients' pharmacovigilance practices.

Navitas Life Sciences’ QPPV services stand out due to our unwavering commitment to pharmacovigilance, safety monitoring, compliance with legislation, and providing exceptional support to clients in establishing and maintaining robust pharmacovigilance systems. Our commitment to drug safety combined with our expertise make us on of the best pharmacovigilance companies.

References:

1. www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices

2. https://www.bfarm.de/DE/Arzneimittel/Pharmakovigilanz/Risikoinformationen/Schulungsmaterial/_functions
/Schulungsmaterial_Formular.html?queryResultId=null&pageNo=0

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