Join this informative webinar that analyses the challenges of globalization in pharmacovigilance (PV), how to overcome them, remain within regulatory compliance and build inspection-readiness best practices.
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 PV challenges for the marketing authorization holders.
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.
In this webinar, 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. Attendees 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 will be an opportunity 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.
Register for this webinar today to gain insights into navigating the diverse regulatory landscapes and managing the intricate challenges of pharmacovigilance.
Speakers
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.
Message Presenter
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.
Message Presenter
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.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following fields or those with the following job titles:
- Pharmacovigilance
- QPPV
- Regulatory affairs
- Quality assurance
- CMOs
- Medical affairs
- Clinical operations
What You Will Learn
Attendees will gain insights into:
- Understanding current and future challenges of globalization in PV
- The PV regulatory inspection landscape, including key differences and commonalities in PV regulations
- The essential elements of maintaining regulatory compliance and inspection readiness
- Practical knowledge to ensure oversight of all activities
Xtalks Partner
Allucent
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
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