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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 organizations.
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/3yOaCg5.

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/4cIyMHy.

We're teaming up with DIA to explore the new EU pharmaceutical legislation and how it will shape the future of the pharmaceutical arena — including research, development and manufacturing — in Europe for decades to come.

We're pleased to announce that registration is now open for the 2024 , an event from DIA and RAPS this December.

Learn more about this new event and get your ticket here: https://bit.ly/3AvWuIN.

At DIA Europe 2024, a resounding message emerged: collaboration is essential to accelerate drug development, empower patients, and transform healthcare delivery.

The conference explored key areas for collaboration, including:
◾ Regulatory Convergence: Harmonising global standards for faster drug approvals.
◾ Effective Data Sharing: Using platforms such as DARWIN EU to maximise the impact of shared data.
◾ AI Integration and Patient Focus: Building frameworks for AI in healthcare while prioritising patient involvement and sustainability.

These are just a few of the many insights shared at DIA Europe 2024. To learn more about how collaboration is shaping the future of healthcare, check out the full article (https://bit.ly/3WUxXpz) and get ready for DIA Europe 2025 (https://bit.ly/3xbhliT).

📢AGENDA RELEASED for the Global Clinical Trial Disclosure and Data Transparency Conference!

Join us for this essential event where industry leaders and experts will delve into the latest in and . From updates to best practices in data sharing, this conference is a must-attend for anyone committed to advancing in .

View agenda at: https://ow.ly/91Tu50SCF1u

The July issue of our is now live! This month, we're diving into groundbreaking topics shaping the future of healthcare and trials with articles like these:

💡 in Wartime: One Patient’s Journey to Survival
💡Implementing -Reported Outcomes in Clinical Trials
💡How to Communicate Unapproved Uses Without Breaking the Law

Stay informed. Stay connected. Together, we're advancing the field! https://ow.ly/XaGF50SzV3x

The EU regulatory landscape for medicine development is complex, but our session from DIA Europe 2024 on ‘Complexity: Interplay and Interface of Different Legislations’ can help! This session explores the challenges and opportunities that arise when various regulations intersect in the development and manufacturing of medicines.

Join a diverse panel of experts including medicine developers, policymakers, regulators, patients, and academics as they discuss:
◾ The impact of overlapping regulations in R&D and manufacturing.
◾ Practical strategies to navigate these complexities.
◾ Guiding principles for effective policy development.

Don't miss this valuable resource! Watch the session now and gain insights to navigate the evolving regulatory environment: https://bit.ly/3zx0sAb.

For more information and to stay updated on DIA Europe 2025, visit our website: https://bit.ly/4cIyMHy.

{𝐍𝐞𝐰 𝐞𝐁𝐨𝐨𝐤 𝐉𝐮𝐬𝐭 𝐑𝐞𝐥𝐞𝐚𝐬𝐞𝐝!} 𝐀𝐜𝐡𝐢𝐞𝐯𝐢𝐧𝐠 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐢𝐧 #𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐈𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭

Get our eBook and learn valuable insights for teams: Best Practices in Capabilities and Functional Interfaces: https://ow.ly/JmJx50SzS7g

Don't miss BioSpace's Lori Ellis (Katz) in her incredible interview with U.S. Food and Drug Administration's Dr. Peter Marks!

FDA CBER Director Dr. Peter Marks Discusses Industry Growth, Collaboration and Communication | BioSpace At the DIA Global 2024 Conference, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA), and Lori Ellis, head of insights at BioSpace, discussed the advancements being made to help drive forward drug and medical device develop...

On 4-7 November, join us at the Paediatric Investigation Plans course. This training is a great opportunity to get a full introduction to the Paediatric Investigation Plans (PIPs) as well as the EU Paediatric Regulation.
Curious about what you will learn? Hosted by leading experts from the EMA and consultancy, this course will cover:
✅ Definitions, Regulation, Guidelines
✅ PIP Lifecycle: Preparation, submission, modifications
✅ Global Paediatric Plan
✅ PIP Opinion
✅ Special issues: Pharmaceutical forms and formulations, non-clinical studies, clinical studies

Register by 9 September to benefit from the early bird rate: https://bit.ly/3LeDj8q.

Have you checked out the Solution Providers Marketplace yet? Discover the solutions you need, or offer your expertise to help organizations like yours thrive: https://ow.ly/juxO50SuKcp

At , a panel of experts, including Dr. Peter Marks, Director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research, expressed strong support for the accelerated approvals program. It has expedited drugs that fulfill unmet medical needs and provided patients with life-extending treatments for rare cancers.

Joanne Eglovitch recaps the session via Regulatory Affairs Professionals Society (RAPS): https://ow.ly/eIuE50Stfv9

Extending a heartfelt thank you to the San Diego Blood Bank and to all of the incredible heroes at ! Together, we've made a difference and helped save lives.

𝐅𝐮𝐧 𝐅𝐚𝐜𝐭: A whopping 93% of event donors were first-timers! Your generosity and support will make a tremendous impact to those in need!

Dr. Zili Li, DIA Fellow and former Chair of the China Regional Advisory Council, and David Mukanga, Deputy Director of Africa Regulatory Systems at the Gates Foundation, have joined DIA's Board of Directors. They will strengthen our commitment to advancing the worldwide by helping provide clarity, direction, and policy objectives.

Learn more about the latest additions to the board: https://www.diaglobal.org/en/resources/press-releases/2024/07-01-dia-board-of-directors

As we gear up for , we are excited to share a curated selection of recent publications highlighting collaborative developments within the Canadian sector.

𝐀𝐫𝐭𝐢𝐜𝐥𝐞 𝐒𝐩𝐨𝐭𝐥𝐢𝐠𝐡𝐭: Industry Perceptions and Experiences with the New Active Substance Work-Sharing Initiative ( ): Survey Results and Recommendations
➡️https://ow.ly/Mn2a50St2Jg

𝐀𝐛𝐨𝐮𝐭 𝐭𝐡𝐢𝐬 𝐚𝐫𝐭𝐢𝐜𝐥𝐞: Using a survey developed by the industry trade associations of the five Access Consortium countries—Australia, Canada, Singapore, Switzerland, and the United Kingdom (UK)—this study gathered insights into the perceptions and experiences of the Access pathway held by affiliates of pharmaceutical companies.

BioSpace’s ⁠Head of Insights Lori Ellis and VP of Marketing ⁠Chantal Dresner attended and shared what they learned from sessions on clinical research workforce trends, digital twins, and trial design on the “Denatured” .

They also discussed some event highlights, including Lori's upcoming exclusive interview with the U.S. Food and Drug Administration’s Dr. Peter Marks:

BioSpace at #DIA2024: Workforce Trends, Trial Design, Peter Marks & Recap BioSpace's ⁠Lori Ellis⁠ and ⁠Chantal Dresner⁠ bring live updates from ⁠day three of ⁠ in San Diego.

Conversations about permeated , with industry execs and regulators from across the globe coming together to explore the evolving regulatory landscape and outline best practices for adoption.

Rose Purcell, Director of Global Regulatory Policy and Innovation at Takeda Pharmaceutical stressed the importance of patient privacy, data protection, and a responsible approach to . She recommended bringing together a cross-disciplinary data governance team to establish and implement best practices. Effective practices don't need to be created from scratch, she noted, but rather can build on existing guidelines.

Read more about Purcell’s session in Joanne Eglovitch’s article for Regulatory Affairs Professionals Society (RAPS): https://ow.ly/NaCF50Srj3J

Do you want to increase your expertise in pharmacovigilance audits and inspections? Then join us in October for the 𝐀𝐝𝐯𝐚𝐧𝐜𝐞𝐝 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐨𝐯𝐢𝐠𝐢𝐥𝐚𝐧𝐜𝐞 𝐀𝐮𝐝𝐢𝐭𝐬 𝐚𝐧𝐝 𝐈𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧𝐬 virtual live training course.
This course will provide a complete approach to the audit and inspection process from the moment of facing the visit notification to the moment of receiving the report and its conclusions.

Together, we will explore:
◾ PV Audits - QMS Requirements from GVP
◾ PV Audit Universe
◾ Building a Strategic/Tactical PV Audit Planning
◾ Operating Individual PV Audits
◾ PV Inspection Readiness
◾ Management of PV Inspections
◾ Management of Post-PV Inspection Activities

Don’t miss this great opportunity to improve your knowledge in this field! Register by 26 August to benefit from the early bird rate ➡ https://bit.ly/3zwKfuL.

At , Raviv Pryluk, CEO & co-founder of ; Sam Miller, Head of Strategic Consulting at ; and Andrew Stelzer, Head of Business Development at .ai, discussed the potential for digital twins to advance . Their session underscored the challenges yet substantial benefits of employing and to conduct faster, more ethical, and more effective .

Learn more about the use of simulations in clinical research in Andy Studna’s Applied Clinical Trials Magazine piece: https://www.appliedclinicaltrialsonline.com/view/dia-2024-machine-learning-simulations-facilitate-clinical-trials

DIA 2024: Machine Learning and Simulations to Facilitate Clinical Trials Session highlights the value of simulations such as data analysis and endpoint selection in clinical development.

Join us online for the Pharmacovigilance Quality Management System (PQMS) training course, starting on 16 September. Learn about the principles, practical approaches, and regulatory expectations for the PQMS – and much more!
This live-virtual training course will be hosted by:
👉 Wendy Huisman, Director, Vigifit, Netherlands
👉 Jose Alberto Ayala Ortiz, QPPV, PVpharm, Spain

Don’t miss this unique opportunity to get a firm knowledge foundation with hands-on exercises and real-life case studies. Register by 22 July to benefit from the early bird rate: https://bit.ly/3VYtjq2.

The Food and Drug Omnibus Reform Act ( ) required the U.S. Food and Drug Administration to publish guidance on diversity action plans for sponsors of Phase 3 and other pivotal within a year of being signed in December 2022. That guidance, which was finally released today, is crucial because significant underrepresentation of various racial and ethnic groups persists.

In their compelling piece for STAT, ’s Associate Director of Scientific Programs, Tamei Elliott, and Global Head of Science and Regulatory Strategy, Maria Vassileva, share why they’re OK with the delays and make the case that a meticulous approach to setting new standards for trial diversity will benefit patients.

Gain a deeper understanding of why diversity in clinical trials is a fundamental component of ethical research and effective treatment:

FDA: Don't rush publishing your diversity guidance plan. Take your time and do it right Comprehensive diversity guidance will improve clinical trial results, yield a better understanding of treatment effects, and increase trust and participation among underrepresented groups.

[FREE WEBINAR]
𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐒𝐮𝐬𝐭𝐚𝐢𝐧𝐚𝐛𝐢𝐥𝐢𝐭𝐲: 𝐂𝐚𝐧 𝐖𝐞 𝐌𝐚𝐤𝐞 𝐚 𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐜𝐞?
Did you miss the insightful session on sustainability at DIA Europe 2024?
This thought-provoking discussion, featuring a panel of experts from regulatory agencies, industry, and more, explored the pressing issue of the environmental impact in healthcare.

Here’s what you will learn:
◾ Latest European policies driving sustainability in the industry
◾ Bold initiatives to reduce carbon footprint in drug development and clinical trials
◾ Practical steps you can take to minimise your environmental impact

Are you ready to be part of the solution? Watch the session, now available on-demand, and join the conversation about building a more sustainable future for healthcare!
◾ Watch the session: https://bit.ly/4bnfUvU.
◾ Learn more about DIA Europe: https://bit.ly/3xbhliT.

[SPONSORED] From reconnecting with familiar faces to forging new connections, was a hub of collaboration to drive drug innovation forward. Critical Path Institute (C-Path) wants continue the conversation. Reach out at [email protected] or visit c-path.org to learn more.

C-Path stands as the premier neutral organization for bringing together all stakeholders in the drug development process. Leveraging its core competencies, C-Path drive’s innovative, -grade solutions that eliminate roadblocks in and advance treatments and cures. We’d love to connect and discuss ways to partner!

[SPONSORED] Did you catch 's Karen Noonan on the panel, "Breaking Boundaries: Overcoming Policy Crosstalk and Globalization Barriers to Foster Innovation?" Learn more about ACRO's global advocacy:

ACRO Health ACRO advocates as the collective voice of innovative clinical research and technology organizations.