The increasing prominence of biotech companies brings attention to their significant pharmacovigilance responsibilities, especially as these ambitious enterprises gain prominence. Examining the distinctions between pharmacovigilance expectations in the United States and the European Union, this discussion aims to offer insights into a practical roadmap for market selection and compliance.
As biotech firms continue to ascend in the life sciences sector, the realization sets in that their pharmacovigilance obligations, despite being typically smaller in scale, are comparable to those of larger pharmaceutical companies. This poses a challenge for these young, ambitious, and product-focused companies, potentially becoming a hurdle to market success unless they formulate optimal strategies to meet the diverse safety demands imposed by different regulatory authorities.
For many biotechs with aspirations in both Europe and the US, a common preference is to initiate the filing process in the US. Beyond the sheer size of the US market, its appeal lies in the unified governance under a single agency, the FDA. Conversely, in Europe, the path to marketing authorization often extends due to the intricate regulatory landscape. Apart from the central European Medicines Agency (EMA), each EU member state introduces its own set of requirements, contributing to a potentially prolonged approval process.
In this webinar, we will thoroughly examine the United States and the European Union as pivotal territories for biotech companies. Our discussion will provide a comprehensive overview of the diverse pharmacovigilance requirements, shedding light on the complexities involved and identifying key areas where biotech companies are likely to seek additional support.
Join us as we navigate the evolving world of pharmacovigilance in biotech and equip you with the knowledge and strategies needed to thrive in these dynamic markets.
Overview of Pharmacovigilance Legislation in the United States
Overview of Pharmacovigilance Legislation in the European Union
Roadmap for Developing a US Pharmacovigilance System in the EU/EEA: Anticipated Challenges Within and Outside the Pharmacovigilance Landscape
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A seasoned Pharmacovigilance (PV) expert boasting over 25 years of extensive experience in the pharmaceutical industry, Natalia has garnered a wealth of professional insights across all facets of PV globally. Her career spans diverse roles in...
PrimeVigilance, an Ergomed company, has grown to become the leading Pharmacovigilance specialist company, delivering global solutions for clinical safety and post-marketing pharmacovigilance and medical information from our operational hubs based...