11 March, 2024

WEBINAR: Dive into the evolution of EU Pharmaceutical Legislation

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FREE WEBINAR TOPIC

“Marketing Authorization (MA) procedures in light of the EU Pharmaceutical Legislation Reform”

Join us as we unravel the historical legislative changes that have shaped the pharmaceutical industry and explore the visionary future pharmaceutical strategy for Europe. Delve into the upcoming reform of EU pharmaceutical legislation, understanding its objectives, timelines, and impact on the EU Marketing Authorization (MA) regulatory framework. Discover how the planned changes will impact expectations regarding compliance with legislation requirements imposed on Marketing Authorization Holders, covering various aspects of MA such as new procedural improvements and simplifications, as well as dossier or pharmacovigilance information. This webinar aims to provide a comprehensive and concise overview of the expected changes to the European strategic approach, ensuring you stay ahead in navigating the evolving pharmaceutical landscape.

Choose between one of 3 sessions available for this webinar on March 26th:

Session 1: Thu 11 Apr, 6am EDT | 12pm CEST | 6pm CST
Session 2: Thu 11 Apr, 10am EDT | 4pm CEST | 10pm CST
Session 3: Thu 11 Apr, 2pm EDT | 8pm CEST | 2am CST

Agenda:

History of changes to EU Pharmaceutical Legislation
Reform of the EU Pharmaceutical Legislation
Impact on the EU Marketing Authorisation (MA) regulatory framework – Current vs. Proposed

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

About our expert speaker:

Marina Pereira Ramos
Senior Regulatory Affairs Specialist, MAA and Maintenance

Marina’s Regulatory Affairs career spans two decades within the pharmaceutical industry of mostly generics. She has been working on pre- and post-approval activities related to regulatory applications. Her expertise includes the preparation and submission of initial Marketing Authorization Applications (MAA) and variations. Marina is adept at assessing, compiling, and submitting responses to National Competent Authority (NCA) authorities. Her proficiency extends to coordinating harmonized phases, managing Change Requests, and fostering effective liaison with diverse stakeholders. In PrimeVigilance, Marina has been working as a Senior Regulatory Affairs Specialist in the MAA and Maintenance Unit since 2022. She also performs the roles of Local Contact Person for Regulatory Affairs (LCPRA) and Person Responsible for Local Screening (PRLS). She holds a Master’s Degree in Biotechnology Engineering from Universidade Lusófona – Lisbon University Centre, and a Postgraduate Degree in ‘Regulation and Evaluation of Medicines and Health Products’ from University of Lisbon – Faculty of Pharmacy.

Katarina Petrasova
Associate Director of Regulatory Affairs, MAA and Maintenance

In PrimeVigilance, Katarina currently serves as the Associate Director of Regulatory Affairs, MAA and Maintenance Unit, where she offers senior oversight for projects involving marketing authorization applications (MAA) and a broad spectrum of post- authorization product lifecycle activities. Since joining the company in 2013, Katarina has systematically built hands-on expertise, navigating through diverse roles from medical writing to regulatory affairs, working on preparation, compilation, and submission of MA dossiers, managing variations or notifications, and establishing effective liaison with industry stakeholders and National Competent Authorities, ensuring strict alignment with regulatory requirements and market strategy. On the local level, Katarina acts as the Local Contact Person for Regulatory Affairs (LCPRA) with the State Institute for Drug Control in the Czech Republic. Furthermore, her duties include serving as the Local Contact Person for Pharmacovigilance (LCPPV) and as the Person Responsible for Local Screening (PRLS). In terms of education, Katarina holds a Master’s Degree in Natural Sciences, specializing in Immunology, from Charles University in Prague.

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