German Pharmacovigilance Day - Programma

The field of clinical research is undergoing a significant transformation with the introduction of the new European Clinical Trial Regulation (EU CTR). This regulation aims to streamline and harmonize the conduct of clinical trials across European Union (EU) member states by simplifying and expediting their authorization process through a centralized system for application submission and assessment. This shift is expected to improve the efficiency of trial initiation, ultimately accelerating the availability of new treatments to patients.

Direct impact of CTR on Medical Safety is multifaceted ranging from explicit simplification of routine daily tasks (e.g. expedited and periodic reports submission) to implicit changes aiming to advance understanding and application of overall sponsor responsibility (e.g. signal management process). These altogether provide on the one hand important interlink between clinical development and post-approval environment for risk-benefit assessment continuum but on the other hand causes challenges for the stakeholders and especially sponsors of clinical trials in their practical implementation.

We provide initial exploration of the potential impact of the new EU CTR on medical safety and pharmacovigilance. Further research and evaluation are needed to assess the middle- and long-term effects of the new EU CTR on medical safety and pharmacovigilance in general and on EU-based pharmacovigilance service providers in particular and identify any challenges or opportunities that may arise during its implementation.

To ensure the safety of drugs, pharmaceutical companies and regulators need to assess measures for the appropriate management of the risks of drugs at any time from the development phase to the regulatory review and the post-marketing phase.

The Risk Management Plan (RMP) is a living standalone document which entails the continuous risk management of drugs. The RMP ensures that the risks of drugs are evaluated at regular intervals or in response to the progress of post-marketing surveillance and a set of pharmacovigilance activities to minimize the risks of drugs. It lists the safety concerns of a product, important identified risks, important potential risks and missing information.

To address these safety concerns, collection of the missing information, examination of risk factors for important identified risks and causality assessment of important potential risks (the pharmacovigilance activities) or post-marketing activities such as information provision for risk minimization (the risk minimization activities) are described.

In the risk minimization activities, besides the routine risk minimization activities (such as providing information through electronic package inserts), additional risk minimization activities (aRMMs) might be required.

Setting up a global PV system with presence in different countries worldwide may be a challenge, especially for small companies with low volumes of adverse events.

The presentation will focus on the experience with PV third party providers, including managing PV agreements and monitoring the partners locally.

In an increasingly globalized world, companies have no choice but to drive their business internationally if they do not want to lag behind their competitors.

Managing Pharmacovigilance activities globally poses multiple challenges. PV Regulations have different maturity levels, Local Safety Officers may have other obligations in addition to PV (e.g. Quality, Regulatory Affairs) and have multiple reporting lines.

Activities may be defined on a global level and need to be implemented taking into account local legislations.

This presentation highlights some of the challenges, and how interactions and collaborations between headquarter and affiliates can be improved.

To demonstrate CSL’s commitment to protecting public health and improving and saving lives of patients with rare and serious diseases, CSL Behring initiated the Pharmacovigilance (PV) Awareness project Hemaya (“Hemaya” – Arabic for “protection”) for the Middle East and Africa (MEA) region. The goals are to support local partners in order to understand their local requirements and expectations from the local health authority. We are working with our partners to introduce “The Guideline on Good Pharmacovigilance Practices (GVP)” in the country to ensure compliance according to local and global regulations for the entire company.”

As CSL expands its global footprint, the company faces various local regulatory challenges. One of the common issues that many global companies encounter is the ranging local Pharmacovigilance experience and legislation requirements.

Guided by our collaboration and superior performance values, GCSP Regions organization started this unique initiative. Within the Hemaya project, the European & Eastern & Central Intercontinental (ECI) Region Lead Simone Lorenz-Asmus and her team raise awareness in Pharmacovigilance and the implementation of local and global laws and regulations with our distributors in 21 MEA countries – with Oman, Saudi Arabia, United Arabic Emirates, Jordan, Kuwait, and Iran being the first on the list.

At the end of 2022, the EMA send a letter to all EU QPPVs, warning of a potential data privacy issue. As a EU Marketing Authorisation Holder, companies have the responsibility to download ICSRs from EudraVigilance. These ICSRs might also be reportable outside the EU, e.g. FDA. It was identified that during the reporting to the FDA, personal (health) data was submitted in the narrative, which has since been published on the the FDA website.

In this discussion round we encourage companies to exchange which standards were established to prevent the disclosure of personal (health) data in ICSRs and the role of affiliates and Headquarters respectively to ensure that ICSR reporting is adhering to the EU General Data Protection Regulation (EU GDPR)

The EMA is implementing the ISO standards for Identification of Medicinal Products (IDMP) to manage all information related to medicinal products as part of their SPOR project. This implementation has been started several years ago and did only progress slowly but recent developments start to more visible and creating impact. This presentation aims to explain the concept of the global IDMP standard and its implementation in the EU context, covering the cooperation of FDA and EMA as well as the impact on day-to-day operations in both Regulatory Affairs and Pharmacovigilance departments

In recent years, there has been a notable increase in drug shortages in a lot of countries across a wide range of medicines, including both generic and branded medicines.
The impact of drug shortages in Germany is significant and multi-faceted. Firstly, patients may face difficulties in accessing essential medicines, leading to delays in treatment, compromised health outcomes and increased healthcare costs. In addition, healthcare professionals are burdened with the task of finding suitable alternatives or adjusting treatment plans.

The causes of shortages are multifaceted, including manufacturing and supply chain disruptions, regulatory issues, market dynamics and increasing global demand for medicines.
Various strategies and initiatives have been proposed to address these. One key approach is to improve communication and collaboration between stakeholders. Improving transparency and information sharing between pharmaceutical manufacturers, wholesalers, healthcare providers and regulatory authorities can help identify and address potential supply disruptions more efficiently. In addition, the establishment of a centralized database or platform to track and monitor drug availability in real time could facilitate early detection of shortages and enable proactive interventions.

Another approach is to increase the resilience of the pharmaceutical supply chain. Diversifying suppliers, both domestically and internationally, can reduce reliance on a single source and mitigate the risk of shortages caused by manufacturing disruptions.

In addition, promoting domestic manufacturing capabilities and incentivizing the production of essential medicines domestically can contribute to a more robust and self-sufficient pharmaceutical industry.
In addition, some regulatory changes have been proposed like the streamlining and speeding up the marketing authorization process as well as regulatory requirements for manufacturers to maintain a certain level of drug stock.

By implementing these strategies, Germany strives for a more robust and sustainable pharmaceutical supply system, ensuring the availability of essential medicines and safeguarding the well-being of its population.

Generative artificial intelligence (AI) including language models such as ChatGPT and similar approaches by Google and Meta have rapidly gained popularity in a broad range of applications. AI approaches have been used in pharmacovigilance before, but previously this has been largely limited to single case processing, generation of narratives and automated readouts of source documents. Generative language models like ChatGPT have capabilities beyond standardized processes, and it is conceivable that they may be used in more complex pharmacovigilance applications. This presentation aims to review the possibilities of generative AI for various pharmacovigilance tasks, such as signalling and aggregate report writing, and will focus on actual possibilities, but will also discuss limitations and threats.