EFGCP - European Forum for Good Clinical Practice

❗ Less than 2 months left to join our conference! 🎉 On the 22nd and 23rd of October, we welcome you to the 𝗘𝗙𝗚𝗖𝗣 𝗕𝗲𝘁𝘁𝗲𝗿 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀 𝗳𝗼𝗿 𝗖𝗵𝗶𝗹𝗱𝗿𝗲𝗻 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝟮𝟬𝟮𝟰: 𝘊𝘰𝘮𝘮𝘰𝘯 𝘪𝘴𝘴𝘶𝘦𝘴 𝘪𝘯 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵 𝘢𝘮𝘱𝘭𝘪𝘧𝘪𝘦𝘥 𝘪𝘯 𝘱𝘢𝘦𝘥𝘪𝘢𝘵𝘳𝘪𝘤 𝘥𝘳𝘶𝘨 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵 🤝 Active engagement of conference delegates will be welcomed in Breakout Sessions to share learnings, discuss challenges and identify solutions on what could be done to optimise childrens’ access to new medicines, with a focus on the important topics: 1.   Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials. 2.   Use of Real-World Data/Registries in Paediatric Drug Development. 3.   Paediatric-only medicines development/First in child companies.   📝 𝗦𝗲𝗲 𝗼𝘂𝗿 𝗮𝗴𝗲𝗻𝗱𝗮 𝗯𝗲𝗹𝗼𝘄 𝗮𝗻𝗱 𝘀𝗲𝗰𝘂𝗿𝗲 𝘆𝗼𝘂𝗿 𝘀𝗽𝗼𝘁 𝘁𝗼𝗱𝗮𝘆: 🔗 https://lnkd.in/eKrhEpd3 👉 𝗗𝗼𝗻'𝘁 𝗺𝗶𝘀𝘀 𝗼𝘂𝘁: 📅 October 22-23, 2024 📍 Crowne Plaza Brussels Airport

The EFGCP Better Medicines for Children Conference 2024 will start in a few days! EFGCP would like to thank all the partners who contributed to making this event possible in face-to-face format. A big thank you for their support and commitment to: Gold AstraZeneca, EFPIA - European Federation of Pharmaceutical Industries and Associations and Novartis Bronze conect4children Stichting and Sanofi We are looking forward to welcoming you for two intense days of high-quality discussions around Paediatric Drug Development. More Information & registration: https://lnkd.in/eKrhEpd3

Exciting News! The results of eConsent Ethics Committees and sponsors/vendors surveys, driven by the EFGCP - European Forum for Good Clinical Practice eConsent initiative, have been published! The survey reveals interesting insights into Ethics Committees' perspectives and expectations on topics such as: · Minimal signature requirements for on-site, remote with video call, or remote with phone call interactions between investigators and participants. · Personal data hosting requirements. · Important factors for approval, among many other items Interestingly, the regional differences between Ethics Committees may not be as significant as often assumed. On the sponsor and vendor side, the surveys examined drivers, barriers, usability of digital features, and other aspects. While common viewpoints were shared, there were also some notable differences between both organizational types. A huge thank you to susie song of Biogen, Stephen Walker of CSL Behring, Sam Thomas of ClinOne, Eric Delente of Medidata, Steven A. Johnson Jr., M.S., C of Takeda, Edwin Cohen of Evinova, Vinita Navadgi of IQVIA, Radu Alex Antonie of Roche, Nora Rachida Meskini of Debiopharm, Jenna McDonnell of ThermoFisher Scientific, and Valeria Orlova, and all our EFGCP eConsent database team members. Special thanks also to all participating organizations for their valuable survey contributions! Read the full article here: https://lnkd.in/ekU-gxmK Interested in shaping the future of eConsent? Explore the Glossary of eConsent Terms, Fit-for-Purpose Study Framework, and eConsent Study Recommendations on the EFGCP eConsent website. #EFGCP #eConsent #ethics  

𝗘𝗙𝗚𝗖𝗣 𝗕𝗲𝘁𝘁𝗲𝗿 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀 𝗳𝗼𝗿 𝗖𝗵𝗶𝗹𝗱𝗿𝗲𝗻 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝟮𝟬𝟮𝟰  22&23 October 2024 | Face-to-Face | Brussels EFGCP is delighted to announce that Sanofi is supporting the Better Medicines for Children Conference 2024! A big thank you to Sanofi, Kristina AN HAACK and Peter Adamson for their support. 👉 𝗝𝗼𝗶𝗻 𝘁𝗵𝗲 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲:  📅 22 & 23 October, 2024  📍 Crowne Plaza Brussels Airport 🔗 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗵𝗲𝗿𝗲: https://lnkd.in/eKrhEpd3 We are looking forward to Welcoming you for two intense days of high-quality discussions around Paediatric Drug Development. #childrenmedicines #drugdevelopment #raredisease #paediatric #mentalhealth

𝗘𝗙𝗚𝗖𝗣 𝗕𝗲𝘁𝘁𝗲𝗿 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀 𝗳𝗼𝗿 𝗖𝗵𝗶𝗹𝗱𝗿𝗲𝗻 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝟮𝟬𝟮𝟰 22&23 October 2024 | Face-to-Face | Brussels 𝗕𝗿𝗲𝗮𝗸𝗼𝘂𝘁 𝗦𝗲𝘀𝘀𝗶𝗼𝗻 𝗼𝗻 𝘁𝗵𝗲 𝗜𝗻𝗰𝗹𝘂𝘀𝗶𝗼𝗻 𝗼𝗳 𝗣𝗿𝗲𝗴𝗻𝗮𝗻𝘁 𝗮𝗻𝗱 𝗕𝗿𝗲𝗮𝘀𝘁𝗳𝗲𝗲𝗱𝗶𝗻𝗴 𝗜𝗻𝗱𝗶𝘃𝗶𝗱𝘂𝗮𝗹𝘀 𝗶𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 - 𝗧𝗶𝗺𝗲 𝗳𝗼𝗿 𝗮 𝗽𝗮𝗿𝗮𝗱𝗶𝗴𝗺 𝘀𝗵𝗶𝗳𝘁!   This breakout session (BOS) will be the opportunity to share learnings, discuss challenges and identify solutions on what could be done to optimise the inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials while considering what could be the impact and benefits for both mother and child. This important topic reached the global level two years ago with ICH creating an expert working group (ICH E21 EWG) who is currently drafting a guideline. There is a clinical and ethical imperative to generate more and better standardized data to permit informed decision making on the use of medicines during pregnancy and breastfeeding. This could only be achieved through collective action from all stakeholders, so that women will not have to choose between managing their health and having a baby. Distinguished experts will participate in the session: Corinne de Vries, EMA, who is involved in the ICH E21 EWG to represent EC, Europe, will share her views and perspectives as a regulator Lynne Yao, US FDA, will also share her views and perspectives as a regulator Marie Teil, UCB, will explain what has been implemented in her company Tyrza Boersma, Patient representative, will not only share her personal experience but also her views and perspectives as a patient representative. The moderation will be covered by Dr. Martine Dehlinger-Kremer (ICON & EUCROF) and Dr Solange Corriol-Rohou, MD (AstraZeneca), who on behalf of EFPIA - European Federation of Pharmaceutical Industries and Associations and together with European Medicines Agency proposed the topic to ICH. 📝 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗵𝗲𝗿𝗲: https://lnkd.in/eKrhEpd3 #neurohealth #regulatoryupdates #childrenmedicines #raredisease #paediatric

⚠️ Register now for the upcoming EFGCP Better Medicines for Children Conference 2024!🎉 𝗘𝗙𝗚𝗖𝗣 𝗕𝗲𝘁𝘁𝗲𝗿 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀 𝗳𝗼𝗿 𝗖𝗵𝗶𝗹𝗱𝗿𝗲𝗻 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝟮𝟬𝟮𝟰 22&23 October 2024 | Face-to-Face | Brussels On Day One, further to a Key Note focusing on Mental Health and Neurologic Disorders in Children, there will be the opportunity to discuss implications of the new Mechanism of Action Paediatric Investigation Plan, which while considered a child-centric option, is a new option considered by Policy makers who are still working on the revision of the Pharmaceutical Legislation.  Examples of successful EU-funded paediatric projects. One session will focus on multi-stakeholders’ collaboration knowing a number of initiatives are already planned to start in 2024, which will benefit all involved in medicines development including children. The last session will provide the opportunity to discuss the Potential of Artificial Intelligence in Paediatric Drug Development. Day two will provide the opportunity to share Paediatric Collaboration Activities at the Global Level with a panel of regulators from various regions, such as Africa & Middle East, Japan, Australia, Canada, Europe, and the USA. This session will be complemented by a session on Childrens’ Access to Medicines in Developing Countries. Prior to sharing the feedback from Day 1’s Breakout Sessions, a final session will explore the proposed changes to the EU Pharmaceutical Legislation and the implementation of the Health Technology Assessment (HTA) Regulation, to better understand what the major paediatric impacts for key stakeholders might be within early 2025. 🤝 Let’s collaborate, share insights, and drive progress in this critical field. Your participation is key to making a difference! 📝 𝗦𝗲𝗲 𝗼𝘂𝗿 𝗮𝗴𝗲𝗻𝗱𝗮 𝗯𝗲𝗹𝗼𝘄 𝗮𝗻𝗱 𝘀𝗲𝗰𝘂𝗿𝗲 𝘆𝗼𝘂𝗿 𝘀𝗽𝗼𝘁 𝘁𝗼𝗱𝗮𝘆: 🔗 https://lnkd.in/eKrhEpd3 #EFGCP #BetterMedicines #PaediatricHealthcare #Conference2024

Proud to have been part of this excellent session and share the suite of tools developed by my EFGCP - European Forum for Good Clinical Practice eConsent team! Let's together enable fit-for-purpose eConsent models in line with the needs for your study and its stakeholders!

❗ Less than 1 month left to join the EFGCP Better Medicines for Children Conference 2024!🎉 On October 22nd and 23rd, we invite you to be part of an engaging discussion on the 𝗘𝗙𝗚𝗖𝗣 𝗕𝗲𝘁𝘁𝗲𝗿 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀 𝗳𝗼𝗿 𝗖𝗵𝗶𝗹𝗱𝗿𝗲𝗻 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝟮𝟬𝟮𝟰: Common Issues in Clinical Development Amplified in Paediatric Drug Development. This conference will bring together leading experts and practitioners dedicated to improving medical outcomes for children. 🤝 Let’s collaborate, share insights, and drive progress in this critical field. Your participation is key to making a difference! 📝 𝗦𝗲𝗲 𝗼𝘂𝗿 𝗮𝗴𝗲𝗻𝗱𝗮 𝗯𝗲𝗹𝗼𝘄 𝗮𝗻𝗱 𝘀𝗲𝗰𝘂𝗿𝗲 𝘆𝗼𝘂𝗿 𝘀𝗽𝗼𝘁 𝘁𝗼𝗱𝗮𝘆: 🔗 https://lnkd.in/eKrhEpd3 👉 𝗗𝗼𝗻'𝘁 𝗺𝗶𝘀𝘀 𝗼𝘂𝘁:  📅 October 22-23, 2024 📍 Crowne Plaza Brussels Airport #EFGCP #BetterMedicines #PaediatricHealthcare #Conference2024

Thank you to the European Parliament, and congratulations to our distinguished Programme Committee for this great Milestone. EFGCP is delighted to have the European Parliament Patronage for the Better Medicines for Children Conference 2024! 22 & 23 October 2024 | Face to Face | Brussels 👉 More Information & Registration: https://lnkd.in/eKrhEpd3 #HealthConference #Paediatric #DrugDevelopment

𝗩𝗶𝗿𝘁𝘂𝗮𝗹 𝗧𝗿𝗮𝗶𝗻𝗶𝗻𝗴 - 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 𝗼𝗳 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗔𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲 𝗔𝘂𝗱𝗶𝘁𝘀 13 & 14 January 2025 | Zoom Virtual Training The European Forum for Good Clinical Practice (EFGCP) Quality Working Party (QWP) will be holding another Virtual Training session soon. This interactive online workshop is developed and hosted by three experienced leading quality professionals, with broad experience of clinical trials in Europe, the UK and USA. With a primary focus on ICH GCP, delegates will be given the opportunity to understand GCP legislation and how it can be applied to individual audits and audit programmes using a risk-based approach. The course includes both points to consider for face-to-face audits and those conducted remotely. With an open forum for discussion, the course has been used as an introduction for beginners, and a refresher for those with experience, or wanting to develop their existing skills. Certificate: EFGCP certificate of completion upon successful MCQ Test Trainers: - Louise Mawer, Mirabilitas Ltd - Kath Williams KEW Quality Ltd - Trev Simmons, TS CSV QA Ltd 👉 𝗠𝗼𝗿𝗲 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 & 𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻: https://lnkd.in/eXkKi-Vq #ClinicalQualityAssurance #GCPAudit #ICHGCPE6 #MCQTest