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About This Webinar
This webinar will focus on how the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards are being implemented in the European Union and its benefits to the industry. It will describe the services the European Medicines Agency has established to facilitate the management of data (SPOR services). Furthermore, it will illustrate the objective of the DADI project and its impact on stakeholders.
Agenda
- Overview of ISO IDMP standards
- SPOR master data and how it is facilitating the reliable exchange of medicinal product information
- Aim of DADI project and impact on marketing authorization holders (MAHs)
- Q&A Session
Language:
English
Who can attend? Anyone with the event link can attend
Featured Presenters
PrimeVigilance Associate Director of Regulatory Affairs, Registration and Compliance
Ljubica joined PrimeVigilance in 2018 and currently holds the position of Associate Director within the Regulatory Affairs department and is head of the Registration and Compliance unit. She obtained a Master’s degree in Applied Chemistry from the University of Zagreb. She started her career in regulatory as an associate for regulatory intelligence, and later she focused on the EudraVigilance system, especially on the Article 57 database. While at PrimeVigilance, she developed a proprietary automation tool for managing XEVMPD data.
PrimeVigilance Associate Director of Regulatory Affairs, MAA and Maintenance
Katarina joined PrimeVigilance (former PharmInvent) in 2013 after obtaining her master’s degree in Natural Sciences, Immunology at Charles University in Prague. She started as a Scientific Specialist/Medical Writer and has since added the roles of Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS). Through various projects, she gradually moved into Regulatory Affairs, performing medicinal products dossier management activities. Katarina currently holds the Associate Director Regulatory Affairs, MAA, and maintenance role and provides senior oversight in projects involving marketing authorization applications and product lifecycle management in post-authorization. She also acts as a Local Contact Person for Regulatory Affairs (LCPRA) with the State Institute for Drug Control in the Czech Republic.
PrimeVigilance, an Ergomed plc company, was set up by former Pharmacovigilance Regulators in 2008. We have grown to become the leading Pharmacovigilance specialist company, delivering global solutions for both clinical safety and post-marketing pharmacovigilance, as well as medical information from our offices. Having successfully delivered Pharmacovigilance (PV) and Medical Information (MI) services for over 14 years, our experience enables us to offer a comprehensive, top quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs. From its operational hubs based in Europe, the USA, and in Japan. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases, stretching to more than 100 countries.
www.primevigilance.com
Contact: info@primevigilance.com
www.primevigilance.com
Contact: info@primevigilance.com
Founder & Managing Director
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