Today, we want to introduce you to Rafi Kohen, PhD, one of our exceptional scientific talents. 🌟🔬 With an impressive career and academic background in countries like the United States 🇺🇸 and the United Kingdom 🇬🇧, Rafi brings a wealth of valuable experiences to our team. Rafi arrived in Barcelona almost three years ago, and since joining CDM, he has demonstrated great passion and commitment to his work, becoming an essential member of the medical team. 🏥💼 His dedication and excellence are reflected not only in his professional achievements but also in his culinary skills—just try his famous Turkish dish! 🍽️🇹🇷 Thank you, Rafi! 👏 #Lifechanger #MedicalWriter #CDMBarcelona
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Learn more about how you can share your experience and advance ALS research through the ARC Study. Watch our most recent ALS Town Hall recording, led by Alan Premasiri, Sr. Manager, Clinical Operations at ALS TDI here: https://lnkd.in/eEUcJTJC
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🔬Today marks the start of the #replica 2.0 Annual International Meeting, which brings together the international partners of the project for an intense training week. Every year, the members of the Replica team fly to #catania, at the CoEHAR center, to discuss lessons learned, harmonize Standard Operation Procedures for phase 2 and continue the laboratory training emphasizing critical steps for harmonization. #harmonization #replicationstudies #harmreduction Sbarro Health Research Organization Ilmu Kelautan Universitas Padjadjaran Massimo Caruso Giovanni Li Volti 👉 Read about the event https://lnkd.in/dqPVk9sx
CoEHAR welcomes the international partners of Replica
https://www.coehar.org
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Founder and Principal Consultant @ Lucent Clinical Consulting LLC | Clinical and Regulatory Affairs Expert | Board Member
Sponsors and investigators involved in clinical research should note that the Declaration of Helsinki - a foundational set of ethical principles for medical research involving humans - has been revised. The revised Declaration of Helsinki, adopted at the 75th World Medical Association (WMA) General Assembly in October 2024, introduces key updates to address modern ethical challenges in medical research which include: ➡️ 1. Technological Advancements: There is strengthened language regarding the use of big data, artificial intelligence (AI), and machine learning in medical research. This revision emphasizes the requirement for proper consent, (e.g. biobanks and data reuse), and addresses risks like loss of privacy and potential harm from AI tools. ➡️ 2. Informed Consent in Emerging Trial Designs: The revision considers complex trial designs, such as adaptive, platform, and decentralized trials, ensuring ethical standards are upheld. ➡️ 3. Research in Resource-Poor Settings: Ethical principles now specifically emphasize the challenges of conducting research in low-resource settings. This includes ensuring community inclusiveness, post-trial access to treatments, and addressing the geography of vulnerable populations, such as in conflict zones or during pandemics. ➡️ 4. Placebo Use and Ethics: The revision revisits the use of placebos, especially when the best-proven treatment is available, and when it is ethically acceptable to withhold this treatment. ➡️ 5. Vulnerable Populations: There is a stronger focus on protecting vulnerable groups, such as children, the elderly, and pregnant women to ensure their rights and well-being are prioritized during trials. These revisions aim to modernize the Declaration to reflect contemporary ethical challenges in research while maintaining its foundational principles. https://lnkd.in/gDUn-Vnt #clinicalresearch #ethics #declarationofhelsinki #lucentclinical
📢 Breaking news ! The Declaration of Helsinki 2024 Revision has been adopted by the World Medical Association General Assembly in Helsinki this morning, after a 30-month review period. This global reference for medical research involving human participants has been updated to reflect 2024 realities. Substantive changes can be categorised in two areas: ➡️ Participant-centered inclusion, respect and protection ➡️ Research beneficence and value, including the pursuit of “individual and public health”, upholding scientific rigor and integrity, and considered distribution of benefits, risks and burdens. The 2024 revision of the Declaration of Helsinki replaces ‘subjects’ with ‘participants' throughout out of respect for the rights, agency, and importance of those individuals. Special thanks to everyone involved including: 👏 WMA Declaration of Helsinki revision workgroup from 19 countries 👏 Input from 110 partners, including WMA constituent members from two public comment periods 👏 Participants in the eight regional and topical meetings were held across all WMA regions since late 2022 👏 Delegates at the WMA General Assembly who supported the adoption of the DoH More detailed information coming soon highlighting what has been changed to improve this document. See the full text of the Declaration of Helsinki 2024 Revision here 👇 https://lnkd.in/eGtBkrg #declarationofhelsinki2024 #declarationofhelsinki
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#ΑΝΤΙΜΕΤΩΠΙΖΟΝΤΑΣ ΤΑ ΧΡΟΝΙΑ ΝΟΣΗΜΑΤΑ ΠΕΡΑ ΑΠΟ ΤΙΣ ΘΕΡΑΠΕΥΤΙΚΕΣ ΑΠΟΦΑΣΕΙΣ 👆⏱️ 12 𝗱𝗮𝘆𝘀 𝗹𝗲𝗳𝘁 𝗳𝗼𝗿 𝘁𝗵𝗶𝘀 𝗲𝘃𝗲𝗻𝘁 𝘁𝗵𝗮𝘁 𝘄𝗶𝗹𝗹 𝗯𝗲 𝗵𝗼𝘀𝘁𝗲𝗱 𝗯𝘆 𝗛𝗲𝗿𝗮𝗸𝗹𝗶𝗼 𝗧𝗿𝗮𝘃𝗲𝗹 📍 𝗪𝗵𝗲𝗿𝗲 ➡️ National Hellenic Research Foundation ⏰ 𝗪𝗵𝗲𝗻 ➡️ February 17 📅 Day 1 The Conference concerns the approach to the patient with a chronic condition as well as the family, with an emphasis on empathy, active listening techniques, but also the communication of diagnostic uncertainty. In the second part we will continue with issues of attitude formation, discussing patient-centered versus paternalistic medicine, the therapeutic value of increasing and decreasing the Placebo and Nocebo effects, respectively, and whether we are ultimately treating the patient or the whole family. 💻For more information you can see the Conference Website 👉 https://lnkd.in/dQXnJWK7 #HeraklioTravel #PCO #miceevents #miceindustry #scientific #eventprofs #conferences #hotel
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#ΑΝΤΙΜΕΤΩΠΙΖΟΝΤΑΣ ΤΑ ΧΡΟΝΙΑ ΝΟΣΗΜΑΤΑ ΠΕΡΑ ΑΠΟ ΤΙΣ ΘΕΡΑΠΕΥΤΙΚΕΣ ΑΠΟΦΑΣΕΙΣ 👆⏱️ 40 𝗱𝗮𝘆𝘀 𝗹𝗲𝗳𝘁 𝗳𝗼𝗿 𝘁𝗵𝗶𝘀 𝗲𝘃𝗲𝗻𝘁 𝘁𝗵𝗮𝘁 𝘄𝗶𝗹𝗹 𝗯𝗲 𝗵𝗼𝘀𝘁𝗲𝗱 𝗯𝘆 𝗛𝗲𝗿𝗮𝗸𝗹𝗶𝗼 𝗧𝗿𝗮𝘃𝗲𝗹 📍 𝗪𝗵𝗲𝗿𝗲 ➡️ National Hellenic Research Foundation ⏰ 𝗪𝗵𝗲𝗻 ➡️ February 17 📅 Day 1 The Conference concerns the approach to the patient with a chronic condition as well as the family, with an emphasis on empathy, active listening techniques, but also the communication of diagnostic uncertainty. In the second part we will continue with issues of attitude formation, discussing patient-centered versus paternalistic medicine, the therapeutic value of increasing and decreasing the Placebo and Nocebo effects, respectively, and whether we are ultimately treating the patient or the whole family. 💻For more information you can see the Conference Website 👉 https://lnkd.in/dQXnJWK7 #HeraklioTravel #PCO #miceevents #miceindustry #scientific #eventprofs #conferences #hotel
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📢 #speaker #announcement 👉 Program & Registration: https://lnkd.in/dUhHWaxA MED1stMR Final Conference on April 17&18 in Ranst, Belgium - Join the free event and learn more about #mixedreaity #training for #medical #firstresponders Gain valuable insights from Philippe Quevauviller of #DGhome #EU as he explores the crucial link between #research and #policies in the EU, highlighting their pivotal role in managing #disaster #emergencies. 🌐🚨 #EUInsights #PolicyResearchConnection 💪 A funded project goes beyond just its deliverables – it should make a meaningful impact, be tangible and user-friendly, with practical plans for evolving into a product post-project. Don't overlook these valuable insights on MED1stMR! #ProjectSuccess #ImpactfulInnovation
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Innovator | Strategist | Advisor | Consultant | Board Member | Clinical Executive | Regulatory Affairs | Clinical Affairs | Scientific Affairs
For all of you Colleagues! The DIA Global Forum/June 2024 Issue has many interesting articles including those linking clinical research with regulatory matters such as: 1) The Role of RWD and RWE in Shaping Global Regulatory Practices by Jeffrey Brown, TriNetX, LLC. 2) IDMP and Cross-Border Healthcare: Eliminating Language Barriers (Part 4) by Panagiotis Telonis, EMA; Ta-Jen Chen & Ron Fitzmartin, US FDA; and Julia Nyman & Malin Fladvad, WHO-UMC. 3) The Global IDMP Working Group Focus on a Framework for Global Implementation (Part 5) by Isabel Chicharo & Panagiotis Telonis, EMA; Ta-Jen Chen & Ron Fitzmartin, US FDA; and Malin Fladvad & Olof Lagerlund, WHO-UMC. Thank you to all colleagues and authors listed above as well as other authors who contributed to this DIA Global Forum June 2024 issue. Your contributions and thought leadership makes a difference in our understanding of the topics covered. Interested in writing an article that links clinical research with regulatory matters? Contact me here. It would be a great honor for me to work with you in my capacity of Regulatory Science Editor. https://lnkd.in/gg8gfcMX #FDA #clinicalresearch #clinicaltrials #regulatoryaffairs
With our Global Annual Meeting scheduled for this month, we are really pleased to publish our June 2024 Global Forum (Vol. 16, Iss. 6). With reports from the Global IDMP Working Group, our recent DIA Europe 2024, India, Japan, and an interview with the first DIA President from China Ling Su, PhD, FDIA, this issue is truly a GLOBAL Forum. Thanks to our authors and editors Ken Getz, Beth Harper, Teri Karcher, Jeffrey Brown, Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc, Wyatt Gotbetter, Kourtney Davis, Sridevi Nagarajan, Michael Meighu, Panagiotis Telonis, Ta-Jen Chen, Ron Fitzmartin, Julia Nyman, Malin Fladvad, Olof Lagerlund, Vedran Raguž, Deepti Goel, Dr Vijay Venkatraman Janarthanan, Mamoru Narukawa, Toshiyoshi Tominaga. Special thanks to my DIA scientific publication colleagues Sandra Blumenrath and Linda Felaco, and extra special thanks to our Editor-in-Chief Alberto Grignolo Ph.D., FDIA for his sparkling anniversary reflections piece "My First 40 Years with DIA." Please enjoy our June publication!
June 2024
https://globalforum.diaglobal.org
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Heading to the #DIA Europe 2024 in Brussels? 👀 Meet the #JNPMEDI team of experts; Jayden (Joon Hyuk) Lim and Bijesh Manikoth! We can't wait to engage with our valued customers, partners, and industry peers at this fantastic event! Let's discuss how our #MavenClinicalCloud solutions drive innovative clinical trials and achieve your study goals together! See you there! 👋 #DIA #DIAEurope2024 #JNPMEDI #MAVEN #MavenClinicalCloud #DecentralizedClinicalTrials #DigitalClinicalTrials #DCT #ClinicalTrials
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