German Pharmacovigilance Day

Worldwide approximately 200 million women become pregnant each year. Millions of women around the world are considering starting or expanding their families, while living with a severe chronic disease. Many chronic severe diseases are more common in women than men, and often manifest in early adulthood, overlapping with peak reproductive years for women.

However, these women and their healthcare providers often lack the necessary information to make informed decisions about managing their disease during pregnancy and breastfeeding. Does the drug continuation cause any harm to my baby? Does the discontinuation of the therapy or even unadopted dosing cause any harm to my patient?

Unfortunately, many women must trade-off between controlling their disease and family planning: pregnant women are usually excluded from clinical studies and therefore medicines are generally contraindicated or considered unsafe during pregnancy.

In addition, it shouldn’t be missed to include men. There is also a need to further explore the safety of paternal exposure and its potential effect on the pregnancy.

This presentation will reflect what sources of information are currently available to support parents to be and their physicians to take a decision regarding disease management and wellbeing of the baby. Furthermore, the presentation includes examples on how to process a pregnancy report, monitor drug administration during pregnancy and what initiatives could be put in place to receive as much information as possible.

OpenSourcePV promotes the use of open source technology and open source data (FAERS, VAERS) for performing safety monitoring without relying on either the transparency of the Market Authorization Holder, the regulatory authorities or the access to expensive software on the shelf.

After having started by monitoring vaccine spontaneous report data for vaccines such as shingle vaccine during mass vaccination, the covid19 vaccines during pandemic and the RSV vaccine, OpenSourcePV leverages new open source packages such as Diana and expands the scope to drugs to try to answer public concern regarding some drugs, originally developed to treat type-2 diabetes but massively used off label.

This presentation will present exploratory results using publicly FDA data from FAERS and quantitative signal detection methods such as disproportionality but also time-to-onset signal detection and cluster analysis.

Risk management and risk minimisation are key pillars of pharmacovigilance.

The basis for any pharmacovigilance measures is the risk management plan. With revision 2 of GVP module V the main purpose of risk management plans has been refocused, moving away from a comprehensive documentation of safety topics just mirroring the product information to a proactive planning tool enabling an up-to-date life cycle management.

Appropriate risk minimisation measures are essential to ensure that important risks of a medicine are appropriately mitigated and that the product can be safely used.

Whilst routine measures like the product information are in place for any medicine the decision whether to use additional risk minimisation measures or not is more sophisticated. There are a wide range of measures available with educational material being the most prominent one. The selection of the appropriate tools depends on the risk to be addressed as well as the medicine itself and the therapeutic context in which it is used.

GVP module XVI providing guidance on risk minimisation measures is currently undergoing major revision with a view to be updated to revision 3 this year. The update of the core module is accompanied by the provision of two new addenda. One deals with methods for effectiveness evaluation and fills a gap in the field of regulatory guidance. The other addendum looks into a very specific area: pregnancy-specific risk minimisation measures, the importance of which is underlined by recent regulatory decisions.

The session will look into the most recent developments of risk management and risk minimisation with a focus on new guidance available. It will provide insights from a regulatory perspective with examples from the work of PRAC.

Effective risk management in pharmacovigilance requires harmonizing global strategies with local execution. This presentation explores the implementation of Risk Minimization Measures (RMMs), highlighting the challenges and solutions in managing high-risk products like opioids across diverse regulatory environments. We will discuss how companies navigate local implementation while ensuring compliance with varying pharmacovigilance systems.

Central to this approach is the use of partially automated, cloud-based software systems that facilitate real-time coordination and monitoring between global and local teams. These systems enable seamless communication and adaptation of core strategies to local distribution channels, ensuring effective risk minimization and regulatory readiness. Additionally, we will cover methods for evaluating the effectiveness of RMMs and setting goals to monitor their implementation, ensuring continuous improvement and compliance.

The presentation will also emphasize the importance of stakeholder interaction, involving internal stakeholders in decision-making and benefit-risk analyses. Practical insights and successful examples will demonstrate how companies can leverage technology and collaboration to enhance risk management practices, ensuring patient safety and regulatory compliance across different regions.

Social media plays a pivotal role in the marketing of over-the-counter (OTC) medications in Europe, offering tailored advertising to specific target groups.

Consumers interact with social media advertising through actions like liking, sharing, commenting, and contacting pages via private messages, contributing to the dynamic nature of engagement.

While “literature” is extensively referenced in GVP Module VI, “Social Media” is notably absent, reflecting a regulatory lag in addressing this modern communication channel. Limited guidance is provided on managing “digital media”, with no specific mention of sponsored social media channels, despite the surge in platforms like Instagram and TikTok post-2011.

Many pharmaceutical companies are retreating from social media due to perceived challenges, as evidenced by a survey conducted in collaboration with the Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Concerns primarily revolve around the workload associated with handling adverse reaction reports. However, our consumer survey found that only a minuscule 2% of reported side effects were through social media channels.

In my presentation, a solution is offered that enables your marketing team to maintain social media presence while ensuring clarity and guidance on internal workflows and information dissemination.

Navigating the intersection of social media and pharmacovigilance presents significant challenges for mid-size pharmaceutical companies. However, with strategic approaches and innovative solutions, these hurdles can be overcome, ensuring regulatory compliance and effective engagement with consumers.

The presentation will touch on elements such as continued learning in use, ensuring near-deterministic quality assurance for non-deterministic tools and impact of model modernization.

This presentation delves into the impact of recent safety updates from Swissmedic on the daily operations of a Swiss affiliate (Risk Management Plans, ICSR processing, electronic exchange). By examining the regulatory changes and their practical implications, this session aims to equip attendees with the knowledge and strategies necessary to navigate these updates successfully.

The presentation begins by providing an overview of the latest safety updates issued by Swissmedic. Through real-life examples and case studies, the audience gains insights into the practical implications of these updates and the challenges they pose.

The session emphasizes the importance of compliance and highlights strategies for integrating the safety updates seamlessly into day-to-day operations. Building strong relationships and fostering a culture of compliance and continuous improvement are also discussed.

By attending this presentation, participants will gain a comprehensive understanding of the recent safety updates from Swissmedic and their implications for day-to-day operations.

Join us on this enlightening journey through the Swissmedic Chronicles and discover the keys to success in navigating safety updates in a Swiss affiliate.

The presentation aims to provide a comprehensive guide to improving the quality of Individual Case Safety Reports (ICSRs).

With the increasing importance of accurate adverse drug reaction (ADR) reporting in ensuring patient safety, this presentation will delve into the key strategies and best practices for achieving superior ICSR quality.

We will refer to the EU Data Quality Framework for medicines regulation and discuss insights from the recent Multi-Stakeholder Workshop on ADR Reporting.

Attendees will gain a sense of common weak points in ICSR management and discuss actionable strategies to overcome these challenges in real time.