NEWS – Latest Pharmacovigilance Webinar open for registration

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.

Choose between one of 3 sessions available for this webinar on January 31st:

• Session 1: 31 Jan, 6am ET / 11am GMT / 12pm CET
• Session 2: 31 Jan, 10am ET / 3pm GMT / 4pm CET
• Session 3: 31 Jan, 2pm ET / 7pm GMT / 8pm CET

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)

At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.

 

About our expert speakers:

Ljubica Nikolaš
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.

Katarina Petrasova
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.

If you have any questions about our webinar please feel free to contact us.