PharmaLex

Enhance Your Local Pharmacovigilance Operations! Effective management of local #pharmacovigilance (PV) responsibilities is crucial for ensuring patient safety and driving market growth. Join our on-demand webinar to gain the knowledge and tools you need to elevate your PV operations, whether you're a seasoned professional or new to the field. In this webinar, you'll learn about: • Barriers Faced by Local Teams: Discover the common obstacles local teams encounter in managing PV activities effectively. • Key Trends: Explore the latest trends, including local affiliate outsourcing, to manage complex local pharmacovigilance requirements. • Best Practices: Gain insights from real-world case studies on optimizing and aligning PV processes at global, regional, and local levels. Watch now: https://lnkd.in/daqMzZ57

The Nordic RWE and AI Conference in Helsinki brought together 300 participants from various sectors to discuss the latest in real-world evidence and artificial intelligence. From regulatory frameworks to innovative use cases, the event was packed with insights and networking opportunities. Discover the key takeaways from the conference: https://lnkd.in/gTcQgeuu #NordicRWE #AI #PharmaLex #HealthcareInnovation

How to navigate the Nordic market? Our experts in compliance, regulatory activities, quality, distribution, and market and patient access share their insights on managing product launches in the Nordics. Read the article: https://lnkd.in/dQuR3ksh #RegulatoryAffairs #Compliance #MarketAccess #Quality Anne Soikkeli

Navigating market access can be challenging for companies, often requiring innovative approaches to gather evidence for reimbursement discussions. Early phase modeling plays a crucial role in assessing feasibility, guiding product development, enhancing investor communication, and even determining whether to pursue product development. Join Annabelle Forsmark, Associate Director of Health Economics and Outcome Research at PharmaLex, as she explores the significance of early phase modeling and its growing importance in reimbursement and patient access. 🔊 Listen to the podcast: https://lnkd.in/dShD8WZq And don't forget to subscribe to #PharmaLexTalks to get the latest episodes instantly! #MarketAccess #Podcast

EMA Accepts Feedback in Final ATMP Guidelines! 📢 The European Medicines Agency (EMA) has finalized its guidelines on investigational advanced therapy medicinal products (ATMPs) after extensive consultation. PharmaLex experts Pam Dhadda and Tiina Palomäki played a crucial role in providing impactful feedback, leading to significant industry concessions. Discover the details and the key changes: https://lnkd.in/dFC_f5j7 #ATMP #ClinicalResearch #PharmaLex #EMA #Biotech

Tired of juggling safety and clinical tasks? Let us free your teams to focus on what truly matters. Our Pharmacovigilance Solutions streamline processes across the product lifecycle, ensuring speed, accuracy, and compliance every step of the way. Discover how we can enhance the speed, accuracy, and consistency of your pharmacovigilance processes. Learn more about our solutions: https://lnkd.in/dmu2rAGQ Explore our cutting-edge PV technologies, psiXchange https://lnkd.in/dF-4Qd-a and rapidLIVE https://lnkd.in/dYCGK8rr! #PharmaLex #PharmalexSolutions #Pharmacovigilance #SafetyFirst

Our 2024 Corporate Responsibility report highlights the impact of company-wide efforts to deliver on Cencora’s responsibility of creating healthier futures. From investing in team members' holistic well-being to creating resilient and sustainable business operations, while supporting healthcare access in communities worldwide, every day Cencora improves the lives of people and animals around the world.     Explore how Cencora is aligning business strategy with our purpose: https://lnkd.in/eDit7ruA

Join us at the Trial Master File Leadership Summit!📢 🗓️ April 1-2, 2025 📍Cencora Global Headquarters, Conshohocken, PA Connect with industry leaders, explore cutting-edge innovations, and strengthen your network within the TMF community. Don't miss this unique opportunity to gain valuable insights and foster meaningful discussions on TMF management. Key Themes: • Compliance and Inspection Readiness • AI and TMF Digital Innovation • TMF Management Excellence • Comprehensive Collaboration Register now: https://lnkd.in/d6qce7Gb #TMFSummit #ClinicalResearch #TMFManagement #Networking #Innovation #Leadership

Meet Yervant Chijian is a Director of MedTech Services in Australia! 🎙️ 𝗪𝗵𝗮𝘁 𝗶𝘀 𝘆𝗼𝘂𝗿 𝗿𝗼𝗹𝗲 𝗮𝗻𝗱 𝘄𝗵𝗮𝘁 𝗮𝗿𝗲 𝘆𝗼𝘂𝗿 𝗱𝘂𝘁𝗶𝗲𝘀 𝗮𝘁 𝗣𝗵𝗮𝗿𝗺𝗮𝗹𝗲𝘅? As the Director of MedTech Services at PharmaLex, I provide consulting services in the MedTech sector. I assist MedTech and pharma clients with regulatory needs and product commercialization in global markets. Additionally, I manage a team of MedTech consultants, supporting them in servicing clients and aiding in their career development. 🎙️𝗪𝗵𝗮𝘁 𝘁𝗿𝗲𝗻𝗱𝘀 𝗼𝗿 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗱𝗼 𝘆𝗼𝘂 𝘁𝗵𝗶𝗻𝗸 𝘄𝗶𝗹𝗹 𝘀𝗵𝗮𝗽𝗲 𝘁𝗵𝗲 𝗳𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗠𝗲𝗱𝘁𝗲𝗰𝗵 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆? I am passionate about digital health and foresee exponential growth in healthcare's digital aspects. AI technologies have gained significant momentum, benefiting patients in ways still being discovered. AI can take on time-consuming tasks performed by physicians, allowing them to focus more on patient care. For instance, AI can process large amounts of data quickly and identify complex patterns that humans might miss. It can also introduce efficiencies in the health system by supporting health professionals in making treatment decisions and providing access to information from multiple sources. As AI continues to learn and expand its capabilities, it becomes a more trusted source of information for physicians, effectively acting as a physician’s assistant. However, adoption, trust, and regulatory oversight will be crucial for the safe use of these tools. 🎙️ 𝗪𝗵𝗮𝘁 𝗶𝘀 𝗼𝗻𝗲 𝘁𝗵𝗶𝗻𝗴 𝘆𝗼𝘂 𝘄𝗶𝘀𝗵 𝗽𝗲𝗼𝗽𝗹𝗲 𝗸𝗻𝗲𝘄 𝗮𝗯𝗼𝘂𝘁 𝘆𝗼𝘂𝗿 𝗷𝗼𝗯? Several aspects attracted me to consulting. I enjoy the diversity it brings, such as the range of technologies, company types and sizes, and various jurisdictions we encounter. I relish being involved with innovators and contributing to groundbreaking technologies while helping clients commercialize their ideas. Lastly, I find great satisfaction in helping people. Working with clients to achieve their goals is rewarding despite obstacles that come with introducing new technology to new markets. The challenge lies in creatively overcoming these obstacles to ensure technology benefits patients and society. 🎙️ 𝗛𝗼𝘄 𝗱𝗼 𝘆𝗼𝘂 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵 𝘀𝘁𝗮𝘆𝗶𝗻𝗴 𝗮𝗵𝗲𝗮𝗱 𝗼𝗳 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝘁𝗿𝗲𝗻𝗱𝘀 𝗮𝗻𝗱 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻𝘀 𝗶𝗻 𝘆𝗼𝘂𝗿 𝗳𝗶𝗲𝗹𝗱? Working with diverse clients across various technologies gives us insight into current and upcoming trends. As a committee member of AusMedTech Regulatory Affairs Group, and with team members in various industry groups, we connect with industry and regulators to discuss upcoming regulations and issues. Our networked team regularly shares global regulatory updates. Learn more about our team's work: https://lnkd.in/dTSXFAE2 #TeamSpotlight #Pharmalex #Medtech

Explore our global events this month 🌍 Join us as we focus on the European market with exciting events in Italy and Switzerland! 🔹 BIO Europe Spring | March 17-19, 2025 | Milan, Italy 🎙️ Attendees: Alessandro Bider, Riccardo Colombo, Ph.D. & Josef Eiblmaier 🔗 Register here: https://lnkd.in/eRdjEqv 🔹 DIA Europe 2025 | March 18-20, 2025 | Basel, Switzerland 🎙️ Attendees: Trevor Brett, Tim Heyeck, Dr. Laura Boteanu-Jotzu & Soubhik Banerjee 🔗 Register here: https://lnkd.in/diWAy2W7 Don't miss this opportunity to connect with leading experts and expand your network! #PharmaLexInTheField #Pharma #Networking #Events #GlobalExpertis