Pharmaceutical companies have expanded their operations to a global scale. Patients now have exceptionally easy access to medicines and vaccines and to different treatment options. However, this globalization, whilst beneficial, has introduced significant Pharmacovigilance (PV) challenges for the marketing authorization holders.
In this webinar recording, the expert speakers will dive into the multifaceted issues that arise from global PV operations. They will provide insight into the regulatory landscape across different regions, highlighting key differences and commonalities. You will learn about essential elements of a robust global PV system and, crucially, the expectations of regulatory inspectors. Meeting these expectations helps ensure adherence to regulatory obligations, guidance and international standards.
The webinar recording will be informative for PV professionals, both new and seasoned, to enhance their knowledge and gain information that can be practically deployed to overcome the challenges posed by globalization. It will support leaders managing such globalization to learn more about the complexities of global PV, the fundamental aspects to ensuring compliance and inspection readiness at all times and gain critical awareness of the likely challenges that may be encountered, along with strategies to manage them.
Companies must now navigate a labyrinth of diverse local and regional PV requirements, contend with language barriers and manage an ever-increasing volume of safety data. Rapid and accurate evaluation of this data is essential to protect the patients and safeguard public health. Overcoming these challenges requires a comprehensive understanding of global PV regulations, sophisticated tools and expertise across multiple disciplines.
Fill out the form below, and get access to the webinar recording to gain insights into navigating the diverse regulatory landscapes and managing the intricate challenges of pharmacovigilance.
About the Presenters
Ian Kovacs, PhD, Global Head of Pharmacovigilance, Allucent
Ian Kovacs has more than 20 years of professional experience in all areas of pharmacovigilance (including EU QPPV) and medical information, gained within both pharmaceutical companies and CROs. In his current position as Global Head of Pharmacovigilance at Allucent, he is responsible for providing strategic leadership and oversight of global pharmacovigilance services provided by Allucent.
Ian is a highly motivated, business leader with a proven record of accomplishment in establishing and maintaining profitable and compliant pharmacovigilance systems and leading operational teams. He is driven by the ability to develop and lead motivated and effective teams whilst supporting companies to develop and execute their pharmacovigilance strategies. Ian holds a Bachelor’s degree in pharmacology and a PhD in Haematopathology from the University of Southampton.
Georgia Kolangi, MSc, Associate Director, Pharmacovigilance, Allucent
Georgia Kolangi is a health sciences professional with over 15 years of experience in pharmacovigilance. During these years, Georgia has gained extensive knowledge in all aspects of pharmacovigilance and medical information from both an operational as well as leadership perspective.
Prior to joining Allucent, Georgia held several strategic roles in various contract research organisations, most recently as EU/UK QPPV for a large CRO. In her current position as Associate Director in Allucent, she is responsible for overseeing post-marketing activities, including the development of Allucent’s Local PV network. She also acts as an EU QPPV.
Dr. Ernesto Vera-Sanchez, MD, PhD, MPH, Vice President, Department Head GxP Strategy, Allucent
Dr. Ernesto Vera-Sanchez has nearly 20 years of experience as a regulator and an EMA & AEMPS GXP Inspector. His comprehensive knowledge of clinical trial regulations and guidance from EMA/FDA/MHRA/PMDA, as well as his extensive experience in inspection strategy and related procedures, lend to his wide-ranging expertise. Ernesto has led over 400 regulatory inspections at clinical investigator sites, CROs, sponsors and vendors.
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