Insuvia

🔔 Transforming Rx to OTC: What does it take to succeed? Insuvia's professional, Karina Jelkinaite, breaks down the key strategies and considerations for a seamless reclassification. 🌟 Explore how #pharmaceutical companies can unlock new markets and engage directly with consumers. 📖 Read the full article: https://lnkd.in/dvP3wEgK #PharmaceuticalIndustry #RxToOTC #Insuvia

🚀 Join Our Team at Insuvia! Are you a skilled professional in pharmacovigilance or regulatory affairs? We're seeking talented individuals to contribute to our mission of providing exceptional solutions to pharmaceutical and biotech companies. Explore the opportunities to grow your career with us: 🔗 Learn more about our vacant positions: https://lnkd.in/d2UZPn9u 📩 Submit your career inquiry: https://lnkd.in/dswgnGn

💡 Revisit the critical aspects of Marketing Authorization Transfers in the #biopharmaceutical industry. Our Regulatory Affairs expert, Karina Jelkinaite, shares insights to help you ensure a seamless transition—from setting effective dates to managing #pharmacovigilance changes. Here's what you need to know: ✅ Country-specific requirements should shape your Marketing Authorization transfer submission plans. ✅ The complexity of submission strategy varies depending on the marketing status of the medicinal product, particularly for those already on the market. ✅ In such cases, regulatory strategy should include additional measures to guarantee an uninterrupted product supply. These measures may involve: a. Changing the brand name of the medicinal product. b. Considering approval timelines of regulatory authorities. c. Adhering to any grace period specified in regulations. d. Managing the application or notification process for pricing and reimbursement by the new MAH. 📖 Dive deeper into these considerations and more in our full article: https://lnkd.in/dSebRJq3 #Pharma #RegulatoryAffairs #MergersAndAcquisitions #Insuvia

Pharmaceutical companies are required to adhere to Good Pharmacovigilance Practices (GVP) and local regulatory requirements. Insuvia's Quality Assurance Manager, Aiste Pauliukonė, emphasizes the critical role of regular, risk-based audits in sustaining compliance and enhancing patient safety. Risk assessments should be conducted across three pivotal levels: ✔️ Strategic-Level Planning: Aligning pharmacovigilance activities with the company's overarching goals. ✔️ Tactical-Level Planning: Developing specific plans to implement strategic objectives effectively. ✔️ Operational-Level Planning: Executing day-to-day activities to ensure compliance and safety. Implementing risk-based audits not only ensures adherence to regulations but also fortifies the pharmacovigilance framework, ultimately safeguarding patient health. For a deeper understanding, read Aiste's full insights here: https://lnkd.in/dncw_MYN #Insuvia #Pharmacovigilance #QualityAssurance #RiskManagement

🍂 Happy Thanksgiving from Insuvia! On this special day of gratitude, we want to express our heartfelt thanks to our partners, dedicated colleagues, and community. Your trust, collaboration, and commitment inspire us every day. #Thanksgiving #Insuvia

📣 Pharmacovigilance System Transfer: Ensuring Seamless Shift webinar starts today at 12:00 EET. Last chance to register: https://lnkd.in/dyXkjehn Don’t miss out on this opportunity to gain expert insights into Navigating a PV System Transfer—a critical topic in today’s fast-paced and highly regulated pharmaceutical landscape. Join Ada Stelmakiene, Insuvia’s Head of Pharmacovigilance, as she explores the key considerations for any PV system change and shares her expertise on effective planning and execution to ensure compliance, maintain safety, and stay competitive.

⏰ Only 3 days to go! Join us on 28 November at 12:00 EET for a webinar: "Navigating Pharmacovigilance System Transfers: Practical Steps for Success" Seats are limited—secure yours now! 👉 Register here https://lnkd.in/dyXkjehn

📍 Greetings from Milan! The #Insuvia team is excited to be attending the European Pharmacovigilance Congress, an event with a strong scientific focus that brings together professionals dedicated to advancing drug safety. Our team – Ada Stelmakiene, Donatas Grina, Jonas Leonavicius, and Martynas Juzenas – is thrilled to connect with industry peers, share insights, and discuss the latest developments in pharmacovigilance. Whether you're diving into emerging research or exploring opportunities for collaboration, we’d love to meet you! 👉 Stop by the Insuvia stand to learn how we support pharmaceutical and biotech companies in achieving safety excellence. #Pharmacovigilance #DrugSafety #EuropeanPharmacovigilanceCongress #TeamInsuvia

Don't miss Insuvia's live webinar happening next week- 28 November at 12:00 EET. Navigating a PV System Transfer is a challenging yet increasingly crucial task in today’s regulatory and business landscape. In the fast-paced and highly regulated pharmaceutical industry, effective planning and execution of PV system transfers are key to ensuring compliance with global standards, maintaining safety, and staying ahead in a competitive market. Join us as Ada Stelmakienė, Insuvia’s Head of Pharmacovigilance, dives deep into the key considerations for any PV system change and shares her expert insights. Date: 28 November 2024 Time: 12:00 EET Presenter: Ada Stelmakiene, Head of Pharmacovigilance | Insuvia 👉 Secure your spot now to gain valuable insights. Register here: https://lnkd.in/dyXkjehn

#Insuvia is excited to attend European Pharmacovigilance Congress 2024 next week! Our team, Ada Stelmakiene, Donatas Grina, Martynas Juzenas, Jonas Leonavicius, is looking forward to engaging with fellow professionals, discussing the latest industry trends, and exploring innovative solutions in pharmacovigilance and drug safety. If you're planning to attend, let's connect. Schedule an appointment with us: https://lnkd.in/dswgnGn See you in Milan on the 22nd of November! #Pharmacovigilance #DrugSafety #EuropeanPharmacovigilanceCongress