Insuvia Webinar
Despite the maximally harmonized regulatory framework governing medicinal products at the European level, certain aspects remain subject to diverse national regulations across member states. One such area of variance is the regulation of grace periods. Marketing Authorization Holders (MAHs) frequently encounter challenges in understanding and adhering to these national requirements, leading to complexities in medicinal products lifecycle management and medicinal product supply strategies.
In this webinar, we aim to provide a holistic overview of grace period regulations across European countries, consolidating the most recent and updated information into a single accessible resource. By addressing the nuances of national requirements, we seek to empower pharmaceutical companies and regulatory professionals with the knowledge and insights necessary to navigate this intricate landscape effectively.
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Presenter: Lina Kaušakienė is Regulatory Affairs Professional with 9 years of experience built in European (EU and outside EU) and former CIS regions. Due to specificity of working for service providers specialises in navigating the intricacies of biologic and chemical medicinal products across diverse therapeutic areas. Expertise lies in crafting tailored regulatory strategies at the national level while adeptly addressing local requirements. Lina brings a keen understanding of the nuanced regulatory landscapes within each region, enabling her to optimize compliance efforts and streamline approval processes.
Agenda:
- Overview of EU requirements
- Overview of national requirements
- Case studies
- Q&A
Language: English
Open to: everyone who has registered
Duration: up to 45 mins.
The webinar is free of charge.