Webinar Replay: How to Set Up an Effective PV System in the UK and EU/EEA Did you miss our live session? No problem! Catch the replay of our essential webinar, "QPPV Office: Ensuring Compliance and Safety in Pharmacovigilance." This comprehensive guide on PV system implementation covers key roles, best practices, and compliance strategies to ensure drug safety across the UK and EU/EEA. Whether you're revisiting as a refresher or tuning in for the first time, this replay offers invaluable insights and expert advice to elevate your pharmacovigilance efforts. 👉 https://lnkd.in/epxBvxbz Thomas C., David Lough, and Susanna Heinonen #Pharmacovigilance #DrugSafety #QPPV #Compliance #WebinarReplay #Pharma
ProPharma
Business Consulting and Services
Raleigh, North Carolina 127,633 followers
End-to-end bespoke solutions that de-risk & accelerate our partners' and sponsors' drug and device development programs
About us
ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies. With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science!
- Website
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http://www.propharmagroup.com
External link for ProPharma
- Industry
- Business Consulting and Services
- Company size
- 5,001-10,000 employees
- Headquarters
- Raleigh, North Carolina
- Type
- Privately Held
- Founded
- 2001
- Specialties
- Compliance & Quality Assurance, Commissioning & Qualification, Product Lifecycle Management, Medical Information, Pharmacovigilance, Computer Systems Validation, Process Validation, Cleaning Validation, Technology Transfer, CMO Selection, Process Optimization, Clinical Safety, Regulatory Affairs, PAI Readiness, biopharmaceutical, Life sciences, and regulatory
Locations
Employees at ProPharma
Updates
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We are proud of our ongoing collaboration with CHEPLAPHARM This partnership underscores our commitment to high-quality healthcare solutions. We look forward to continued success and a positive impact worldwide.
🎉 Celebrating a Longstanding Partnership with CHEPLAPHARM! At ProPharma, we take immense pride in our ongoing collaboration with CHEPLAPHARM . Over more than 5 years, we've worked hand-in-hand to make significant strides in improving patient health. Together, we've achieved seamless technology transfers and ensured successful dossier registrations for new product acquisitions. This partnership has been a cornerstone of our commitment to delivering high-quality healthcare solutions, and we are excited about the future. Here’s to many more years of success and making a positive impact on patients' lives worldwide! Let´s grow together! #cheplapharm #pharma #technologytransfer #regulatoryaffairs #propharma #partnership
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What is Digital Transformation in Life Sciences? Digital transformation leverages technology to innovate and enhance processes, crucial for staying competitive in life sciences. The main challenges involve multidisciplinary team collaboration and managing vast data volumes. Why It’s Challenging: - Misunderstandings between scientists, IT, and data teams - Ensuring data is clean, contextualized, and accessible - Aligning people, processes, and technology Key to Success: - Strong data strategy - Robust data standards and governance ProPharma's experts bring deep scientific knowledge to guide you through your digital transformation journey. Read the blog to learn more: https://lnkd.in/eUaqm47Y. Author: Dana Vanderwal
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Ensure Compliance with ProPharma's Readiness Assessments Preparing for a regulatory inspection? Our expert auditors conduct thorough readiness assessments and friendly audits to pinpoint compliance gaps before authorities arrive. Stay ahead, navigate inspections with confidence, and maintain compliance seamlessly. Learn more about our services: https://lnkd.in/eAtaGR_A Contact us today to get started! #RegulatoryCompliance #AuditReadiness #QualityAssurance
GxP Audits, Consulting, and Inspections
propharmagroup.com
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We marked our calendar! Make sure you do the same to see ProPharma's CIO, Kirk Wroblewski, as a keynote speaker for PBC Group - Organisers of the COG Series inaugural CRO Summit in Raleigh, North Carolina on December 3rd and 4th!
Welcoming Kirk Wroblewski as a keynote presenter for PBC Group - Organisers of the COG Series' inaugural CRO Summit in Raleigh, North Carolina. Kirk, CIO at ProPharma will be delivering a session titled: Harnessing AI and LLMs within Internal CRO Operations, within the #ArtificialIntelligence section. The first of it's kind, the CRO Summit brings together CRO industry leaders to discuss the latest trends, challenges, and opportunities in the global #clinicaldevelopment landscape. Held on the 3rd & 4th December, at the Raleigh Marriott City Center. The program is in development, if you'd be open to joining the meeting reach out to me directly at djo@thepbcgroup.com
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Our blog post sheds light on the key regulatory considerations, emerging trends, and strategic insights essential for navigating the EU's dynamic landscape. Whether you're involved in gene therapy research or policy development, understanding these regulations is crucial for successful trial execution and compliance. Explore how these developments impact the future of gene therapy and what it means for innovators in the field: https://lnkd.in/ev7bzUdK.
The Moving Regulatory Landscape for Gene Therapy Trials in EU: Part 1
propharmagroup.com
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Tap into this week's #ProPharmaPolls. #PharmaInsights
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Explore the transformative impact of Patient Support Services in our latest eBook, "Patient Support Services: Revolutionizing Access and Empowering Patients in Complex Care" This guide explores how Patient Support Services (PSS) bridges the gaps between patients, providers, insurers, and pharmaceutical companies. Discover strategies for empowering patients and learn about the future of PSS in complex care. Featuring insights from industry experts like Eric Brandon, MBA from ProPharma, and Pratik Chakraborty from Apexon, this resource offers: - The evolving landscape of complex therapies and the rise of PSS - Strategies for empowering patients through PSS - The future role of PSS in complex care Don't miss out! Download your free copy now: https://lnkd.in/ePS23nV9.
Unlock the future of patient care with our latest eBook: "Patient Support Services: Revolutionizing Access and Empowering Patients in Complex Care" 📘✨ Developed by Apexon in collaboration with ProPharma Group, this comprehensive guide dives into the challenges of complex therapies and the pivotal role of Patient Support Services (PSS) in empowering patients. Discover how PSS is transforming the healthcare landscape by bridging gaps between patients, providers, insurers, and pharmaceutical companies. 📖 What you'll learn: - The evolving landscape of complex therapies and the rise of PSS - Strategies for empowering patients through PSS - The future role of PSS in complex care Join industry experts like Eric Brandon, from ProPharma Group and Pratik Chakraborty from Apexon as they share their insights and expertise. Don’t miss out on this valuable resource. 📥 Download your free copy now: https://lnkd.in/g5Xz9tKZ #HealthcareInnovation #ComplexCare #Apexon #Patientcare #Ebook #PSS #Salesforce #Healthcare #Lifesciences #PatientSupport
Patient Support Services: Revolutionizing Access and Empowering Patients in Complex Care
apexon.com
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What is a PSMF? The Pharmacovigilance System Master File (#PSMF) is a comprehensive document the EU requires, detailing the pharmacovigilance system of a Marketing Authorisation Holder (#MAH). It ensures compliance with safety regulations and supports the monitoring of medicinal products. Learn more about the structure, requirements, and maintenance of the PSMF. Read our blog: https://lnkd.in/eyjesv4w. Author: David Lough
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Unlocking New Pathways: Understanding the FDA's Animal Rule Explore the FDA's Animal Rule and its crucial role in developing drugs for serious or life-threatening conditions caused by toxic agents. Learn how animal studies ensure efficacy, the impact on drug development, and how sponsors can navigate regulatory requirements with ProPharma's expert guidance. https://lnkd.in/gZcvDEAG #DrugDevelopment #FDA #AnimalRule