NuPhaC’s Post

Well-structured training is key to advancing paediatric medicine 🌍👩⚕️ Rebecca Leary from Newcastle University describes how the c4c package covers essentials like Good Clinical Practice while embracing new innovations that help more children to participate in research🧒✨ https://lnkd.in/eB8pFjDf EFPIA - European Federation of Pharmaceutical Industries and Associations, EU Science, Research and Innovation, Innovative Health Initiative (IHI) #GCP #PaediatricResearch #Education #Training #PaediatricMedicine #Collaboration #c4cvoices

🔊 Attending the #PatientsAsPartners conference in London this week was a remarkable experience. The event brought together diverse stakeholders, primarily from the pharmaceutical industry and contract research organizations (#CROs), to discuss and showcase advancements in patient involvement within the drug development process. 💡 Despite notable progress in patient engagement and involvement activities compared to previous years, there remains significant room for improvement. A particular area of concern is the inclusion of pediatric patients in the design and execution of clinical trials. Currently, these young patients are often not considered a standard part of the process, which is a gap that needs addressing. 🎤 🎤 🎤 Advocates for patient involvement emphasize the importance of integrating patient perspectives whenever they can add value, making it a mandatory part of clinical research to ensure it aligns with the needs and preferences of patients. While it is understood that involving patients directly in clinical studies may not always be feasible, caregivers—who possess extensive experience and knowledge from managing specific conditions around the clock—can provide crucial insights and should be included. For those looking to incorporate patient involvement in their projects, it is essential to recognize that there are always avenues and opportunities to do so. Engaging the right experts who can ensure that the involvement is grounded in solid scientific principles is crucial for delivering meaningful outcomes. Therefore, never hesitate to reach out to those with expertise in patient engagement to guide you in this process. At the European level, the network representing the expertise of professionals working in PPI in children's hospitals is eYPAGnet: www.eypagnet.eu If you need our advice or our services, we will be happy to serve! Joana Claverol Naomi Litchfield Michelle Gunn Patients As Partners in Clinical Research Community News #PatientInvolvement #PatientEngagement #ClinicalTrials #ClinicalResearch #ChildrensRights #DrugDevelopment #PatientEmpowerment #PatientEducation

It's so important that we think holistically about how to drive continuous improvement in the clinical trials environment in the UK. Successful clinical trials delivery involves multiple partners – sponsors, regulators, clinical investigators and their teams, trial sites and their imaging, radiology and pathology and R&D offices. The interdependent system requires all the component parts to work in harmony. R&D Directors UKRD from across the country, many of them active clinical trialists themselves, have shared their insights and perspectives into the biggest challenges facing the trials system in the UK and the things that need to be done to improve the system. Supporting staff to run trials, creating capacity for service support departments, streamlining systems - in the NHS and sponsors/CROs - and clarifying regulatory requirements all featured highly in what these R&D leaders told us. Improvements will come from all system partners embracing the challenges, taking responsibility for improving/optimising their parts of the system and working together to identify innovative solutions. Resources need to be pointed towards the parts of the system that have the greatest need. Department of Health and Social Care NHS England NIHR (National Institute for Health and Care Research) NIHR for Industry The Academy of Medical Sciences The Association of the British Pharmaceutical Industry (ABPI) Health Research Authority Royal College of Physicians NHS Lucy Chappell Lindsey Hughes

🎉 Celebrating International Clinical Trial Day 2024: Our Commitment to Advancing Healthcare 🌟 Last week, Symbiance team proudly celebrated International Clinical Trial Day 2024, reaffirming our unwavering dedication to the healthcare industry. This day holds deep significance as it honors the pioneering work of James Lind, whose clinical trials in 1747 laid the foundation for modern medical research. During our celebration, we reflected on the essential role clinical trials play in transforming patient lives. Our team shared impactful stories and insights from our journey in clinical research, highlighting the collective impact we have made. At Symbiance, every effort is driven by a commitment to excellence and innovation. Symbiance's Contribution: As a leading CRO, Symbiance has been at the forefront of clinical research, partnering with healthcare providers, pharmaceutical, and biotech companies to bring new therapies to market. On this special day, we created awareness about the critical importance of clinical trials and their role in advancing medical science. A Heartfelt Thank You: We extend our deepest gratitude to our dedicated team members, partners, and, most importantly, the patients who participate in clinical trials. Your trust and collaboration are the driving forces behind our success and the advancement of global healthcare. Together, we continue to pave the way for a healthier future, transforming hope into reality, one clinical trial at a time. Few Key Points About International Clinical Trials Day Historical Significance: Commemorates the first controlled clinical trial conducted by James Lind on May 20, 1747, which laid the foundation for modern clinical research. Raising Awareness: Aims to increase public awareness about the importance of clinical trials in advancing medical knowledge and improving patient care. Highlighting Contributions: Recognizes the vital role of clinical trial participants, researchers, healthcare professionals, and organizations in the development of new treatments and therapies. Promoting Ethical Standards: Emphasizes the importance of ethical conduct, patient safety, and regulatory compliance in all clinical research activities. Fostering Collaboration: Encourages collaboration among global stakeholders, including pharmaceutical companies, research institutions, and regulatory bodies, to accelerate the development of innovative medical solutions. Ilango Ramanujam Tamilselvi Senthilkumar Balamurugan Dhayalan Pathamuthu Kumar Gajendran Ramkumar M.Rajendiran Nishath Altaf Jayapandian Nagamalaiyan Susan Gallop Mark Pittman Suresh Narayanasamy B.E., M.B.A. #InternationalClinicalTrialDay #ClinicalTrials #HealthcareInnovation #Symbiance #CommitmentToCare #AdvancingMedicine

MEDIcept Minute: FDA Promotes Clinical Trial Innovation Dive into the world of cutting-edge medicine with us this Clinical Trials Day! In honor of Clinical Trials Day, yesterday, May 20th, the FDA released its latest initiatives aimed at promoting clinical trial innovation. From cutting-edge trial designs to embracing digital health technologies, FDA is paving the way for a more accessible and diverse landscape in clinical trials. The FDA’s ongoing initiatives, such as their collaboration with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Medical Device Regulators Forum, aim to support innovative trials and protect participants. Additionally, their efforts to enhance diversity in clinical trials, as outlined in published guidances, ensure that all patients are represented. The FDA’s Center for Drug Evaluation and Research (CDER) has also recently established the Center for Clinical Trials Innovation (C3TI) to enhance clinical trial efficiency by sharing knowledge, enabling demonstration projects, and providing coordinated support for innovation-related inquiries. Read more at the link below about how the FDA is promoting clinical trial innovation. https://lnkd.in/eYcb7CYm Join us here at MEDIcept in celebrating the progress made and the endless possibilities ahead in the world of clinical trials! Contact MEDIcept today at sales@medicept.com for your clinical trial needs, and let’s shape the future of healthcare together! #clinicaltrials #cro #fda #clinicaltrialsday #medicaldevices #clinical #innovation

🚨 EU Joint Clinical Assessment – What you need to know 🚨 Having just returned from ISPOR Europe, where the European Union Joint Clinical Assessment (EU JCA) was a major focus, it’s clear that this topic is top of mind for Pharma and Medtech leaders preparing for 2025. The team here at Mtech Access have updated their article on the JCA to reflect the latest developments and offer insights into the challenges and opportunities this new process presents. 🔎 In our updated article, we cover: 👉 Key timelines and requirements for JCA implementation 👉 What the JCA means for local HTAs 👉 Challenges for manufacturers, including PICOs management and submission timelines 👉 Strategic advice on navigating these changes To stay informed about the evolving EU HTA landscape and what it means for your business, read our updated article: https://lnkd.in/eZQ_nmHs If you’d like to discuss the JCA or how Mtech Access can support you, drop me a message or email info@mtechaccess.co.uk #HTA #EUJCA #ISPOREurope #JCA #pharma #medtech

🚨 EU Joint Clinical Assessment – What you need to know 🚨 Having just returned from ISPOR Europe, where the European Union Joint Clinical Assessment (EU JCA) was a major focus, it’s clear that this topic is top of mind for Pharma and Medtech leaders preparing for 2025. The team here at Mtech Access have updated their article on the JCA to reflect the latest developments and offer insights into the challenges and opportunities this new process presents. 🔎 In our updated article, we cover: 👉 Key timelines and requirements for JCA implementation 👉 What the JCA means for local HTAs 👉 Challenges for manufacturers, including PICOs management and submission timelines 👉 Strategic advice on navigating these changes To stay informed about the evolving EU HTA landscape and what it means for your business, read our updated article: https://lnkd.in/etwy7ixd If you’d like to discuss the JCA or how Mtech Access can support you, drop me a message or email info@mtechaccess.co.uk #HTA #EUJCA #ISPOREurope #JCA #pharma #medtech

𝐀𝐂𝐂𝐄𝐏𝐓𝐄𝐃 𝐟𝐨𝐫 𝐭𝐡𝐞 𝟐𝟗𝐭𝐡 𝐞𝐝𝐢𝐭𝐢𝐨𝐧 𝐨𝐟 𝐭𝐡𝐞 𝐄𝐀𝐇𝐏 𝐂𝐨𝐧𝐠𝐫𝐞𝐬𝐬 We are happy to share that our work has been selected for presentation at the congress of The European Association of Hospital Pharmacists (EAHP). This opportunity to share our experience as clinical pharmacists within an oncogeriatric unit is significant because: - It highlights how the active involvement of pharmacists in care units brings clear added value to patient management - Regardless of the type of institution where pharmacists practice, it is possible to develop meaningful and impactful projects that are recognized by the wider community - Sharing experiences through various publications is achievable and an integral part of clinical pharmacy practice. This work is the result of a collaboration between medical and pharmacist doctors , which we want to emphasize. A special thanks to Polyclinique Lyon Nord - Vivalto Santé for providing opportunities to develop innovative projects that showcase the value of our pharmaceutical team. #EAHP2025 #ClinicalPharmacy #ClinicalPharmacist #Oncogeriatric #VivaltoSante

James Lind is not a name most of us recognise and yet we all owe him a huge debt of gratitude. His comparison of potential remedies for scurvy back in 1747 is widely considered the first ever randomised clinical trial and a turning point in the history of medical research.   International Clinical Trials Day continues to shine a light on his groundbreaking legacy and rightly so. To this day, the relentless pursuit of evidence-based medicine and robust clinical trial design underpins our industry’s efforts to develop life-changing medicines for the people who need them most. That is why, as a member of the board of the European Federation of Pharmaceutical Industries and Associations (EFPIA), I am so passionate about the importance of reversing downward trends in Europe’s R&D and clinical trial investment. To restore Europe’s reputation as an innovation powerhouse, we must fast-track smarter, more patient-centric trials and increase the global share of clinical trials in Europe.   While the pace of medical advancement has completely transformed the healthcare landscape since the 18th century, I see Lind’s curiosity, thirst for knowledge and quest for scientific rigor in my own Astellas colleagues as we seek to advance innovations with the greatest potential to transform lives.   #ClinicalTrialsDay #CTD2024

🚨 EU Joint Clinical Assessment – What you need to know 🚨 Having just returned from ISPOR Europe, where the European Union Joint Clinical Assessment (EU JCA) was a major focus, it’s clear that this topic is top of mind for Pharma and Medtech leaders preparing for 2025. The team here at Mtech Access have updated their article on the JCA to reflect the latest developments and offer insights into the challenges and opportunities this new process presents. 🔎 In our updated article, we cover: 👉 Key timelines and requirements for JCA implementation 👉 What the JCA means for local HTAs 👉 Challenges for manufacturers, including PICOs management and submission timelines 👉 Strategic advice on navigating these changes To stay informed about the evolving EU HTA landscape and what it means for your business, read our updated article: https://lnkd.in/eZyPrgvw If you’d like to discuss the JCA or how Mtech Access can support you, drop me a message or email info@mtechaccess.co.uk #HTA #EUJCA #ISPOREurope #JCA #pharma #medtech