National Differences For Pharmacovigilance Requirements In Europe.
Webinar date & time: March 7th 15:00 CET
Join our webinar on “Navigating National Differences in Setting up a Pharmacovigilance System in Europe.” This session will discuss the regulations and guidelines to consider when implementing a pharmacovigilance system in Europe.
From country-specific reporting requirements to cultural considerations, we will cover the key factors you must consider to ensure compliance and effective pharmacovigilance practices across the region. Whether you’re a pharmaceutical company looking to expand into the European market, or an existing player looking to optimize your pharmacovigilance processes, this webinar will provide valuable insights and practical tips for success.
The webinar will lead by our field experts, who share their experiences and best practices. So let’s dive in and explore the complexities and opportunities of pharmacovigilance in Europe.
Register here!
Albert Befki, MSc
Head of Global Pharmacovigilance Operations
Albert is a pharmacovigilance expert with over 11 years of experience in the field. He has vast experience in different pharmacovigilance operations, from literature monitoring, vendor management, global and local case processing oversight, to safety database management. Before joining Biomapas, Albert held several strategic pharmacovigilance roles in various outsourcing service providers. He has extensive leadership experience in the pharma industry, which led him to become the Head of Pharmacovigilance Operations at Biomapas.
Setting up Pharmacovigilance In Europe?
Let’s talk how we can team up to conduct them effectively and ensure smooth processes.
Other content that might interest you:
MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics
Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers, pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder. During the National semi-annual conference „Pharmaceutical News“, State Medicines Control Agency presented the statistics of suspected ADRs reporting in Lithuania.
Biomapas appoints Head of Global Pharmacovigilance
March 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry, Biomapas, appointed leading pharmacovigilance professional Martijn van de Leur as Head of Global Pharmacovigilance. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, Biomapas continues to strengthen its international team and geographical coverage of its services globally.
What is a Safety Signal?
Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new potentially causal association between an adverse event, beneficial response and a medical product, or a new aspect of causal association that was previously known. Usually, a signal will be relevant for all products with the same active ingredient, including the combination products. Further, let’s look more at the main steps of the safety signal management.