Ensuring Safety Beyond Approval: A Practical Guide to Pharmacovigilance Systems

Medicon Valley Alliance and TFS would like to welcome you to a Good Morning Meeting on the 18th of June 2025.

Pharmacovigilance (PV) is a dynamic and essential part of ensuring post-marketing safety, especially as regulations evolve and new data types emerge. In this session, we’ll explore the critical steps involved in setting up a comprehensive PV system that meets the growing demands of safety monitoring.
We’ll cover the three core phases of a PV system set-up:

• Start-Up Phase: Understand the groundwork needed before getting Market Authorization, from setting up the safety database to risk management and early regulatory engagement.
• Pre-Approval Phase: Learn how to manage your PV System after Market Authorization and before receiving product approval and launch, focusing on adverse event reporting, signal detection, and ongoing safety reviews.
• Post-Marketing Phase: Discuss the ongoing surveillance required after product launch, including signal management, periodic safety reports, and regulatory compliance.

This session is designed for clinical and operational leaders, regulatory professionals, and safety managers who are looking for actionable strategies to set up and manage a PV system that meets modern safety demands. Whether you’re in the early stages of building a PV system or working to optimize an existing one, this discussion will provide the insights and tools you need to navigate the complexities of pharmacovigilance with confidence.

Date: Wednesday 18th of June 2025
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2

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Program

Speakers​​

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Luis Goméz García, Head of Nordics Strategic Resourcing Solutions, TFS Health Science Luis V. Gómez is a results-oriented executive with over 18 years of international experience driving business growth, strategic partnerships, and operational excellence across the pharmaceutical, healthcare, and water management industries. Currently serving as Head of Nordics at TFS HealthScience, Luis leads regional operations and business development, managing a multinational team and overseeing strategic delivery and P&L performance. Throughout his career, Luis has held senior roles at companies such as Novo Nordisk, ThermoFisher Scientific, and SUEZ Group, managing multimillion-euro budgets and international teams. He has a strong track record in stakeholder engagement, strategic negotiation, and P&L leadership. A multilingual leader fluent in Spanish, English, and Danish, Luis combines a strong technical foundation in chemical engineering with a Master’s in Administration. He is known for his ability to manage complex stakeholder environments, lead change, and deliver sustained commercial success.

Mario Clementi, Drug Safety Manager and QPPV, TFS Health Science Mario Clementi is an accomplished pharmacovigilance leader with over 15 years of experience spanning clinical development and post-marketing safety. He holds a Master of Medical Science in Biomedicine and has held senior leadership positions, including EU and UK QPPV, Director of Pharmacovigilance, and Head of Global PV. His core competencies include regulatory compliance, global safety governance, audit and inspection readiness, and risk management planning. Known for his strategic oversight and operational excellence, Mario has led international PV teams through complex integrations, regulatory inspections, and the development of robust, inspection-ready safety systems. He brings deep expertise in both EU and UK pharmacovigilance frameworks, with a strong track record of ensuring sustained regulatory compliance across diverse portfolios. Fluent in Italian, Swedish, English, and German, Mario currently serves as Drug Safety Manager and QPPV at TFS HealthScience, where he provides expert leadership and end-to-end oversight of pharmacovigilance systems for global clients.

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