DIA

We are excited to collaborate and provide two virtual webinars in September focusing on real-world data! These opportunities are complimentary and are a fantastic way to stay at the forefront of real-world topics. Inclusivity as a Part of Feasibility: Making Trials More Representative with RWD In Collaboration with: Optum September 12 | 12:00-1:00PM ET | Register Here: https://lnkd.in/eZ-BEhZW Raising the Bar on Real-World Data Quality: Ensuring Regulatory-Grade EHR Data In Collaboration with: Truveta September 18 | 1:00-1:45PM ET | Register Here: https://lnkd.in/ejcJks6Y Want more real-world collaboration? Check out our upcoming Real-World Evidence conference in Philadelphia, PA this fall! ➡️ https://lnkd.in/egNfP_gD #RealWorldEvidence #RealWorldData #RWE #RWD #Learning #Webinar

"Users of #RWD analysis reported that RWD add context to and increase confidence in signal assessments, and that RWD analyses reduce time to decision-making when done rapidly and properly. Rapid RWD analyses can bring awareness to potential #safety issues sooner which, in turn, promotes patient safety and public health. Routine users indicated that most signal assessments could benefit from rapid RWD analysis while non-routine users showed a greater unmet need for rapid analysis.” #realworlddata #data #regulatory #rwd #realworldevidence #outcomes #patientoutcomes #realworldoutcomes #pharma #innovation #dia #pharmacovigilance #ehr #claims DIA #ema #fda #ispe2024 #pharmacoepidemiology International Society for Pharmacoepidemiology

We are delighted to present the outcomes of the DIA Europe 2024 Pre-Conference Workshop on "Reliance for Post-Approval Changes: How do we move from Exceptional to Routine Use?" and the DIA Global Forum Article on "Making Global Reliance a Reality for Post-Approval Changes of Medicines and Vaccines". As the regulatory landscape evolves, the need for global collaboration has never been more critical. This workshop brought together global regulators and industry leaders to discuss how reliance models can be expanded to streamline post-approval changes (PACs) across markets. The outcomes highlight key steps toward making reliance for PAC a routine practice, reducing delays, and ensuring timely access to medicines and vaccines worldwide. ◾ Download the outcomes: https://bit.ly/4cKzpzm. ◾ Read the Global Forum article: https://bit.ly/3X8Nzok. As we look ahead, we invite you to join us at the DIA Europe 2025 to continue these critical discussions. Let’s work together to foster collaboration, drive innovation, and create a sustainable future for global healthcare. Register by 14 November to benefit from the early bird rate. ◾ Registration link: https://bit.ly/4aN1NA1. Chimwemwe Chamdimba, Biljana Tubić, Elkiana Rama, Nélio Cézar De Aquino, Jiaqi Lu, Tao Wang, Xiangyu Wang, Sabina Uzeirbegovic, Hamada Gamal, Martin Harvey Allchurch, Reem Al-Naimat, Ahmed Hussein Babiker, Bandar Alhammad, Marko Eric, Mladen Bogdanovic, F. Handan Öztunca, Musa Durak, Marie Valentin, Samvel Azatyan, Gugu N Mahlangu, Alison Bond, Lucia D'Apote, Mark Pellett, Priti Shah, Michael Cunha, Vera Lucie Wardhana, Hugo Ta, Michelle Czajkowski, Andrew Deavin, Dave Rush, Sérgio Cavalheiro Filho, Ginny Beakes-Read, Greg Jordinson, Chloé Garay, Sonia Cappellini, isabelle colmagne-poulard, Wan Li Liao, PhD, Angelika Joos, Mic McGoldrick, Inas Hujeiri Chehimi, Jacob Larsen, Aine Kane, Anjana Patel, Yameng (Melly) Lin, Susanne A., Corinne CHABASSOL, Lyne Le Palaire, Anna Czwarno, Magda Bujar, Tamei Elliott, Sara Torgal #DIAEurope2025 #LifeSciences #Sustainability #Reliance #Collaboration

Join us at the DIA Middle East & North Africa Conference (MENA) 2024, where key stakeholders will come together to address the unique challenges and opportunities in the MENA region. This year, we will explore vital topics including regulatory developments, digitalisation, clinical trials, and more — all to advance healthcare in the region. The early bird rates are ending in less than a month. Follow our event page for the latest updates and details. #MENA2024 #DIA #RegulatoryInnovation #HealthcareCollaboration

We are excited to collaborate and provide two virtual webinars in September focusing on real-world data! These opportunities are complimentary and are a fantastic way to stay at the forefront of real-world topics. Inclusivity as a Part of Feasibility: Making Trials More Representative with RWD In Collaboration with: Optum September 12 | 12:00-1:00PM ET | Register Here: https://lnkd.in/eZ-BEhZW Raising the Bar on Real-World Data Quality: Ensuring Regulatory-Grade EHR Data In Collaboration with: Truveta September 18 | 1:00-1:45PM ET | Register Here: https://lnkd.in/ejcJks6Y Want more real-world collaboration? Check out our upcoming Real-World Evidence conference in Philadelphia, PA this fall! ➡️ https://lnkd.in/egNfP_gD #RealWorldEvidence #RealWorldData #RWE #RWD #Learning #Webinar

This is your last chance to register for the Pharmacovigilance Quality Management System (PQMS) live-virtual training course! Get acquainted with the principles, approaches, and regulatory expectations for the PQMS in this highly interactive and hands-on course. Plus, watch the video featuring one of the instructors, Jose Alberto Ayala Ortiz from PVpharm, as he highlights the key benefits of this training and why you shouldn't miss out! 🎥 Don’t miss out on this opportunity to deepen your expertise, boost your career, and ensure regulatory compliance in this critical area. Seats are filling fast! Secure yours now: https://bit.ly/3KZ8NiC. #PQMS #DrugSafety #Pharmacovigilance #Learning #QualityManagement

Explore the emerging EU AI regulatory landscape and its impact on medicines development with this on-demand session from DIA Europe 2024. The session features a distinguished panel of speakers from the European Commission, industry, regulatory agencies, and patient organisations. Gain key insights into the EMA/HMA's draft reflection paper on AI in medicines, understand the importance of responsible and reliable AI development throughout the medicines lifecycle, and receive practical recommendations from regulators, legislators, patients, and industry. Watch it now: https://bit.ly/474Gvxx. To continue these critical discussions, join us at DIA Europe 2025 in Basel, Switzerland, from 18-20 March, where the focus will be on sustainability, innovation, and collaboration in healthcare. Register now to take advantage of early bird rates available until 14 November: https://bit.ly/3LmbH19. #ArtificialIntelligence #AI #RegulatoryAffairs #DIAEurope #Learning

Only 1 day left to secure early bird registration for the DIA/ FDA Oligonucleotide-based Therapeutics Conference (28-30 Oct 2024, Washington DC). It's going to be a great meeting! https://lnkd.in/ed9Ezu3h

Join us online for the Medical Writing of PSUR/PRER Training Course, starting on 15 October. Learn more about best practices in source data collection, essential role of quality checks (QC) during the whole process of report preparation, and critical aspects of medical writing, including data editing and presentation. This live-virtual training course will be hosted by: ◾ Sven Schrip, Head of Global Pharmacovigilance Writing, Boehringer Ingelheim, Germany ◾ Jan Kolouch, CEO, Strategic PV Advisor, NextPV Services s.r.o., Czech Republic Don’t miss this unique opportunity to get a firm knowledge foundation on the medical writing of PSUR/PBRER with hands-on exercises. The early bird rate is ending next week. Register today: https://bit.ly/3yMKPEZ. #Pharmacovigilance #DrugSafety #PSUR #MedicalWriting #Learning

We are counting down the weeks until this year's Real-World Evidence Conference! Our Program Committee has been hard at work to bring you informative, relevant sessions that will allow you translate insights into real-world value. Early Bird rates are available until end of day tomorrow and spots are limited - take advantage and secure your spot today! #RWE24 #RealWorldEvidence #RWE #LifeScience