We invite you to join our latest PrimeVigilance knowledge-sharing webinar titled „Exploring the Crucial Role of Local Persons for Pharmacovigilance on a Global Scale“!
This webinar aims to explore the essential role of local person in ensuring effective pharmacovigilance worldwide. It will highlight the valuable contributions of local person in promoting compliance with national regulations within a rapidly changing pharmacovigilance landscape.
Through this webinar, we will delve into the core responsibilities of local person in pharmacovigilance, examining their perspectives from different territories, including both EU and non-EU regions. We will draw on our experience to discuss the challenges and opportunities presented by evolving regulatory frameworks and changing pharmacovigilance legislation in different territories.
Attendees can expect to gain valuable insights into the critical role of local person in pharmacovigilance and the importance of leveraging local knowledge and experience to drive effective pharmacovigilance practices on a global scale.
Choose between one of 3 sessions available for this webinar on May 4th:
- Session 1: Thu 04 May, 6am EDT | 10am GMT | 11am CET
- Session 2: Thu 04 May, 10am 10am EDT | 2pm GMT | 3pm CET
- Session 3: Thu 04 May, 2pm EDT | 6pm GMT | 7pm CET
- Navigating Regulatory Frameworks
- The Vital Role of Local Person in Pharmacovigilance
- Insights on Compliance Management by Marketing Authorization Holders
- Staying Ahead of the Curve with the constant Evolving of the local person role for pharmacovigilance
At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.
About our expert speakers:
Katarina Srećković Lažetić
Regulatory Affairs Manager
Katarina currently holds position of Regulatory Affairs Manager in PrimeVigilance.She has gained deep knowledge in management and compliance with GVP requirements for vast number of products. She has significant knowledge with Local partners management, setting up new projects to meet commercial objectives.
Katarina gained vast expertise in different project complexities, where she is providing valuable PV consulting and guidance on local regulation to PrimeVigilance customers, developing SOPs and Work Instructions and supporting with quality aspects (CAPAs, audits) in the pharmacovigilance field.
Katarina has a broad local legislation knowledge with strong focus on EEA region, as well as on ROW regions such as MENA and LATAM.
Senior Regulatory Affairs Manager
Sanja currently holds position of Senior Regulatory Affairs Manager within PrimeVigilance. She has extensive background in representation of projects of high complexity ensuring effective and rapid set-up, high quality oversight management and execution of regulatory tasks. Sanja provides regulatory strategic input to customers and supports them to promptly identify and address any risk/potential by proposing preventive measures and finding adequate solutions in alignment with Global and Local PV regulations. She is experienced in developing strategies and managing project set up activities (such as local SDEAs, Project specific guidelines, Responsibility delegation matrix, and similar) for ensuring compliance and consistency with national requirements. Sanja additionally integrates her technical knowledge with regulatory acumen to provide guidance to the project teams across PrimeVigilance. Sanja’s experience in local PV extends throughout the EEA, EAEU, MENA and LATAM region.
If you have any questions about our webinar please feel free to contact us.