10 June - 15:00 - 16:00 BST / 16:00 – 17:00 CET
Mastering Grace Period Requirements in EU
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.
Agenda
• Overview of EU requirements
• Overview of national requirements
• Case studies
Who should attend this webinar?
• Global Regulatory Affairs Managers
• Local Regulatory Affairs Managers
• Compliance Officers
• Quality Assurance Managers
• Medical Writers
• Regulatory Intelligence Analysts
• Regulatory Operations Managers
Speaker: Lina Kaušakiene
Lina Kaušakiene is Regulatory Affairs Professional with 10+ years of experience built in European (EU and outside EU), EAEU 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.
This webinar is sponsored by Insuvia
Disclaimer: Whilst TOPRA is running this webinar for Insuvia, this is not an endorsement of Insuvia, Insuvia's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.
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Pricing
- Members: free
- Non-members: free
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