PharmaLex

This week, our Subject Matter Experts (SMEs) will be making their mark at two major events: SCOPE 2025 in Orlando, US, and Labquality Days in Helsinki, Finland. Join us as we delve into the latest innovations in clinical trials, digital health, and quality in laboratory medicine and health technology. 🔹 SCOPE Summit 2025 | 03-06 February, 2025 | Orlando, United States 🎙️ Attendees: Seth Pearl, Dave Stephens, Jaclyn Spicer, PMP & David Biondi 🔗 Register here: https://lnkd.in/g9N7SgA 🔹 Labquality Days | 06-07 February, 2025 | Helsinki, Finland 🎙️ Attendees: Tiina Riihimäki & Nina Andersson 🔗 Register here: https://lnkd.in/d3sD54jC Don't miss out on these opportunities to connect, learn, and innovate with industry leaders! #PharmaLexInTheField #Pharma #Networking #Events #GlobalExpertise

PharmaLex's February Newsletter is Here! 📧 Pharmaceutical companies are focused on innovation while keeping products on the market. Staying ahead of regulatory and legislative developments, incorporating next-gen technologies, and working with partners is crucial. 📈 Managing the Mature Portfolio through Strategic Outsourcing Navigate the complex regulatory environment and optimize your mature product pipeline with insights from PharmaLex’s Chief Strategy Officer, Kirsten Jacobs, PhD . 🤖 Understanding the Implications of the European AI Act Learn how the European #AI Act impacts the pharmaceutical industry and how robust data governance can help navigate these challenges. 🌐 The Digital #Pharmaceutical Journey: 2025 and Beyond Discover the trends driving digital innovation in the pharmaceutical industry. 📂 A Year of Reflection and Preparation for the #TMF Stay updated on the evolving trial master file (TMF) standards with insights from PharmaLex’s TMF expert, Rob Jones 🌍 Navigating Complex EU Manufacturing and Supply Chain #Commercialization Requirements Understand the challenges and strategies for entering the EU market. Listen to our podcast for more details. 🛡️ Understanding Local PV Obligations in a Global Landscape Join our webinar to learn how to navigate local #pharmacovigilance requirements and avoid safety-related delays. 📅 Join Our Upcoming #Webinars February 13th: UK’s International Recognition Procedure February 27th: Navigating Local Pharmacovigilance Obligations in a Global Landscape Stay ahead of the curve with the latest industry developments. Join our newsletter today! #PharmaLex #Innovation #RegulatoryAffairs #DigitalTransformation #Outsourcing

Explore the Nordic Pharmaceutical Market 🔎 Discover how collaboration and local expertise are key to navigating the unique challenges of the Nordic pharmaceutical market. From compliance to distribution, learn the essential steps for a successful product launch in Sweden, Norway, Denmark and Finland. Read full article here: https://lnkd.in/dQuR3ksh #Nordics #MarketAccess #Pharmaceuticals #HealthcareInnovation

TMF Document Processing Service - your one-stop solution for eTMF needs! Discover how our TMF Document Processing Service can help improve the efficiency and quality of your eTMF management processes: https://lnkd.in/ebd7Gm_f Partner with us today! 🤝 #TMF #QualityAssurance #RiskManagement #Pharmalex

We were delighted to attend the #RAPS #DIA combination products EU conference in Brussels! It was an outstanding opportunity to connect with industry leaders and fellow professionals while discussing the latest developments in regulatory affairs and healthcare innovation regarding Combination Products. The event provided valuable insights into emerging trends and regulatory updates, fostering meaningful discussions about the future of our industry. #RAPS #DIA #Regulatory #Healthcare #Networking #Pharma #MedicalDevices #CombinationProducts #Innovation

With rising awareness of the environmental impact of pharmaceuticals, new legislative proposals aim to make medicines more environmentally sustainable. Key changes include stricter requirements for Environmental Risk Assessments (ERA) and more comprehensive mitigation measures. 🌱 🔍 Highlights: • Marketing authorization applications can now be refused if ERA is incomplete or insufficient. • Broadened scope to address antimicrobial resistance. • Regular updates to ERA, similar to pharmacovigilance requirements. • Introduction of a monograph system for environmental information on active substances. • Stay ahead of the curve and understand how these changes could impact your pharmaceutical operations. Read the full blog by Angela Vogt-Eisele: https://lnkd.in/dpczjAcS #PharmaLex #Pharmaceuticals #Legislation #ERA #HealthcareInnovation #Sustainability

🌍 Are you a biopharmaceutical company looking to expand into new markets or manage growth in existing markets? Don’t let complex local and regional pharmacovigilance requirements slow you down. Join our webinar: “Navigating Local Pharmacovigilance Obligations in a Global Landscape” Our experts will share: • Key strategies for effective local pharmacovigilance • Best practices for maintaining compliance across diverse regulatory frameworks • Insights into operational flexibility and resource management • Benefits of outsourcing to specialized partners Register now: https://lnkd.in/dKN_eGNj Discover how to take the burden off your local operations so you can focus on strategic priorities! #Pharmacovigilance #Biopharma #MarketGrowth Chris Englerth José Miguel Rivas Romero Annette Pausch Ana Raquel Gouveia Kati Kokkonen

Join us at SCOPE Summit 2025 in Orlando, Florida! Our experts are here until February 6th, ready to showcase our latest innovations and discuss how we can help you achieve your goals. Visit us at booth 132 and don't miss this opportunity to connect with our team! #SCOPE2025 #Innovation #Networking #Healthcare

Join us at the 37th Pharmacovigilance UK & EU 2025 in London! Governments worldwide are investing heavily in #pharmacovigilance to detect, understand, and prevent the increasing adverse drug reactions (ADRs), driving significant market progress. This event will bring together top pharmaceutical, biotechnology, and regulatory representatives to address key industry issues. Don't miss our Speaking Session: 🗓️ Day 1 – February 12, 2025 | 11:50 – 12:20 🎙️ Speakers: Alex Brenchat & Jose Miguel Rivas Topic: Best practices: Having the right local setup to comply with country pharmacovigilance obligations Meet the team: ➡️ Alex Brenchat, Vice President, PER, Practice Area Lead, LPVS Cencora PharmaLex ➡️ Josemiguel Rivas, Director, Pharmacovigilance Cencora PharmaLex ➡️ Abdullah Yassin, Business Development Manager UK & Ireland Cencora PharmaLex Register here: https://lnkd.in/d8KTi6rD Take this opportunity to network with your peers, exchange expertise and experiences, and arm yourself with the latest information within the industry. #Pharmacovigilance2025 #PharmaLex #ClinicalTrials #Innovation #Networking

Meet Ruth Power, our dedicated Associate Director of Promotional Materials and Compliance for the APAC region! 🎤 𝗪𝗵𝗮𝘁 𝗶𝘀 𝘆𝗼𝘂𝗿 𝗲𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲? Following a clinical career as a medical scientist, I have spent the past 13 years in the biopharmaceutical industry in senior medical affairs roles. My expertise spans specialty therapeutic and diagnostic portfolios across the Australia, New Zealand and Asia Pacific regions. As a medical affairs leader, I have held enterprise-level governance and compliance lead roles, with responsibility for the development and leadership of ethics, governance, and compliance initiatives for local and regional affiliates. I am a committed patient advocate, who thrives on the opportunity to deliver patient-focused healthcare strategies and solutions that drive the safe and effective use of medicines and medical and diagnostic interventions toward optimal patient outcomes. 🎤 𝗪𝗵𝗮𝘁 𝗱𝗼 𝘆𝗼𝘂 𝗹𝗼𝘃𝗲 𝘁𝗵𝗲 𝗺𝗼𝘀𝘁 𝗮𝗯𝗼𝘂𝘁 𝘆𝗼𝘂𝗿 𝗷𝗼𝗯? I joined PharmaLex in November 2024 and am excited to bring my expertise to this dynamic and evolving solutions-focused consultancy company in the delivery of customer and patient value through client- and patient-focused solutions and services that span the entire product life cycle. What I love most about my job is the collegial and client-oriented culture that encourages collaborative industry partnering. Our objective is to ensure tailored and compliant promotional and non-promotional strategy, solutions, and materials across the various stages of the product life cycle from pre-launch, through commercialization, to on-market, and maturity. As a consultant with PharmaLex, I am thoroughly enjoying the diversity, breadth, and depth of scope, and the variety of opportunities and challenges inherent in my role. 🎤 𝗪𝗵𝗮𝘁 𝗶𝘀 𝘆𝗼𝘂𝗿 𝗳𝗮𝘃𝗼𝗿𝗶𝘁𝗲 𝗵𝗼𝗯𝗯𝘆? I am both a city and a nature lover, continuously in pursuit of a balance between the two. I embrace metro adventures, time out in nature, and travel to vibrant city and peaceful coastal and country destinations near and far with family and friends. #TeamSpotlight #PMC #APAC