EFSPI (European Federation of Statisticians in the Pharmaceutical Industry)

This #InternationalWomen’sDay, we are excited to share that our EFSPI (European Federation of Statisticians in the Pharmaceutical Industry) colleague, Justine Rochon has been recognized in Reuters Events: Trailblazing Women in Pharma 2025 list.   We encourage you to take a moment to explore the Trailblazing Women in Pharma 2025 list and celebrate the achievements of women in our industry. Congratulations on your recognition, Justine!   Check out the nominees in the report now: https://lnkd.in/eJt4gyMG   Reuters Events Pharma #IWD #womeninpharma #EFSPI

Basel Biometric Society Meeting on Covariate Adjustment in Clinical Trial Covariate adjustment is well known and common in statistical modelling, but its use in the analysis of clinical trials is still rather limited. The BBS - Basel Biometric Society organizes a half-day meeting is dedicated to covariate adjustment in clinical trials and will provide a theoretical as well as practical view on the topic. Case studies will be presented and their alignment with FDA and EMA guidance on adjusting for covariates will be discussed. Registration link in comments.

🌟 Participation of #EFSPI in the ACT EU Workshop on ICH E6 R3 at EMA in Amsterdam 🌟 We are very pleased to share that EFSPI (European Federation of Statisticians in the Pharmaceutical Industry) was represented at the ICH E6 R3 (principles and Annex 1) workshop focusing on the revised guidelines for Good Clinical Practice (GCP) last month. The ICH E6(R3) guideline, set to come into effect on 23 July 2025, focuses on 11 #principles of #ICH #GCP. These principles are intended to offer flexibility and be adaptable to a wide variety of clinical trials, promoting approaches that are fit for purpose and enhancing the efficiency of trial design and execution. The objectives of the workshop were to: 📚 Offer a comprehensive overview of the significant updates in the ICH E6(R3) guideline, including those from the draft version released for public consultation. 💡 Outline the key concepts for modernizing GCP in light of recent advancements in trial design, organization, and technology, with an aim to ensure the guideline remains relevant in the future. 🤝 Encourage dialogue with stakeholders on the practical application of ICH E6(R3). The workshop was designed to involve a wide array of stakeholders in the ICH E6 R3 process, including patients, healthcare professionals, investigators, regulators, service providers, ethics committee members, academia, and the industry. For #EFSPI, an organization that represents 10 statistical associations across Europe and is committed to scientific excellence, it was a great opportunity to contribute our perspectives through our former EFSPI president, Justine Rochon. The video recording and presentations from the event are available on the event page: https://lnkd.in/edkB4bBD. We extend our gratitude to the European Medicines Agency, especially Emer Cooke for the invitation to participate, and to Peter Twomey and team for their excellent leadership and management of the workshop. We are optimistic about the future and how these developments will continue to foster improvements in clinical trials, ultimately aiding in making well-informed decisions for the benefit of patients. We congratulate all those involved, look forward to keep the momentum and hopefully contributing to the workshop on Annex 2, led by Andrew Thomson.

On 19th March the Basel Biometric Society (BBS) is organizing a webinar on From Statistical Innovations to Common Practice, How to innovate with impact? Join this event to hear about how to identify and mitigate barriers to implementation of statistical innovation within your organizations. Learn how several pharmaceutical companies successfully roll-out statistical innovations to change common practice within their organizations. Learn from industry and regulatory experts how to make your organization a strategic and impactful contributor for innovation in drug development. Relevant links in comments. Kaspar Rufibach Nicky Best Monika Jelizarow Elina Asikanius Frank Bretz Stephen Ruberg Michael Krams Tobias Mielke Marisa Bacchi #innovation #commercialization #statistics

EFSPI (European Federation of Statisticians in the Pharmaceutical Industry) is committed to fostering an environment where innovation thrives, and we believe that the collaborative efforts in the open-source arena are enablers to achieving this vision.

💥 Here it is—the final EFSPI quarterly newsletter of the year! As 2024 draws to a close, we reflect on an inspiring and impactful year for our community. This year saw exciting milestones, including the establishment of new ESIGs on cutting-edge topics such as AI/ML, Causal Inference, and Patient-Focused Drug Development, as well as the launch of the Scientific and Training Academy. Our partnerships flourished, with stronger collaborations with ASA BIOP and closer ties to the Next Gen group, while preparations for our new website reached their final stages. 🌟 None of this would have been possible without the unwavering support, energy, and dedication of our community. Whether through participation in events, contributions to ESIGs, or leadership roles, you have been the driving force behind our success. 💫 Looking ahead to 2025, we are excited to celebrate the 10th Regulatory Statistics Workshop, launch our new website, and host more dynamic events to engage and inspire statisticians across industries. Together, we will continue to strengthen our impact and advance statistical innovation. 🎄 From all of us at EFSPI, thank you for making this year extraordinary. Wishing you and your loved ones a wonderful holiday season filled with joy, peace, and warmth. Here’s to a bright, healthy, and successful New Year! 🎉 Sincerely, EFSPI Council Egbert Biesheuvel Justine Rochon Emmanuel P. Pierre Mancini Christoph Gerlinger Andrea Nizzardo Luca Grassano Stefan Driessen Jonas Häggström Magnus Kjaer Lilla Di Scala Kaspar Rufibach Christine Fletcher Jennifer Visser-Rogers Stéphane Munier An Vandebosch Anders Gorst-Rasmussen Teppo Huttunen Anna Wiksten

Do you want to contribute to the scientific program of the EFSPI Regulatory Statistics Workshop? The EFSPI Regulatory Statistics Workshop is a bespoke annual meeting that attracts an ever-growing number of participants. Last year, we reached the venue’s maximum capacity for face-to-face attendees. Additionally, several hundred colleagues joined us virtually from around the world.   The success of the workshop hinges on the Scientific Committee. Each year, under the leadership of our chair, Helle Lynggaard, the committee engages in in-depth discussions to design a strategic program. The committee is composed of regulatory and industry colleagues in approximately equal numbers. General principles for the composition of the Scientific Committee are summarized in the slidedeck linked in the comments.            We are inviting applications for new members of the Scientific Committee. We are looking for individuals who:     ●       Are willing to learn about the unique culture that has been built over a decade in organizing the EFSPI workshop. ●       Have extensive drug development and regulatory interaction / statistics experience. ●       Can devote time to about 4-6 preparatory TCs, put together sessions, plan and chair sessions, propose short topics, and attend the workshop in person. The general selection criteria are (for details, check out the slide deck): o  Balanced representation of EFSPI regions o  Maximal one member per company o  Diversity in terms of gender, region, organization size    It is important to recognize that the work in the Scientific Committee is a very collaborative effort – contributing to the Scientific Committee is not about you and your career, it is about contributing to the continued success of the EFSPI Regulatory Statistics Workshop.   Industry Scientific Committee Members are generally elected for two years with the potential to apply for a one-year extension. If interested, please submit a short statement until 18th December 2024 with your background and what you would like to bring to the Scientific Committee to Helle Lynggaard, hlyn@novonordisk.com.

📢 Exciting Updates from EFSPI! The Q3 2024 Newsletter is out! 🌟 We’re thrilled to share this quarter’s highlights, filled with remarkable achievements and upcoming opportunities that reflect the momentum within our community. 👏 Here’s a sneak peek at what’s inside: 🔹 Welcome Message – A word from EFSPI President Egbert Biesheuvel on this quarter’s success and what’s ahead. 🔹 EFSPI Council – Who We Are – Know the dedicated individuals behind EFSPI. 🔹 Event Highlights – A look back at the 9th Regulatory Statistics Workshop, which brought over 774 statisticians and experts together in Basel! Thanks to Kaspar Rufibach and Helle Lynggaard for this incredible success! 🔹 Collaboration with American Statistical Association - ASA – Strengthening transatlantic ties and sharing knowledge across statistical communities. Thanks to Justine Rochon, Emmanuel Zuber, Mouna Akacha for representing EFSPI! 🔹 New EFSPI Website – Launching soon with a fresh, user-centered design for easier access to resources and events! Thanks to FluidaMente - Web Marketing Agency, for the hard work done so far! 🔹 SIGs Updates – Key takeaways from the Preclinical SIG on advanced R&D methods. 🔹 National Groups Updates – Including highlights on exciting events to come! IBIG - Italian Biostatistics Group, PSI: Statisticians in the Pharmaceutical Industry, BBS - Basel Biometric Society, PSDM 🔹 Did You Know? – Celebrating the legacy of David Cox, a pioneer in survival analysis and clinical research. This edition captures the remarkable advancements, partnerships, and events that define our work. Don’t miss out – read the full newsletter to stay connected and inspired! Thank you for your continuous support and active involvement. Let’s make the next quarter just as impactful together! Best wishes, Andrea Nizzardo & Luca Grassano EFSPI Communication Officers

🔵 Next ESIG Leaders meeting! 🔵 EFSPI is excited to announce the next ESIG Leaders Meeting scheduled for November 28th. This meeting is a unique opportunity for our leaders to connect, collaborate, and contribute to the ongoing growth and success of the ESIGs. We currently have 24 ESIGs running, each one a testament to the dedication, innovation, and hard work of its members. Your incredible work has been instrumental in driving forward our mission and we couldn't be more proud. This meeting will be a platform to celebrate ESIGs' achievements, share insights, and strategize for the future. Mark your calendars and stay tuned for more details. We look forward to facilitating this important discussion! #EFSPI #ESIGs #Collaboration #Innovation

PSDM Networking event at Astellas in Leiden (NL) on Tuesday 26 November The PSDM board invited you to a networking event hosted at Astellas Pharma in Leiden, the Netherlands. Get together with Data Managers, Programmers and Statisticians who work in clinical research in the Netherlands. There will be presentations on relevant topics like working with Git, Statistical Computing Environments, external controls, and of course plenty of time to network.