Certara’s Post

It's been a few months since the European Medicines Agency relaunched Policy 0070. Since then, our Transparency & Disclosure team at Certara has worked on quite a number of submissions for various pharmaceuticals, and we've observed a few things: 1. Although the policy is still in its first few months, the EMA is quite organized and very responsive. 📩 - From preparing structured Lists of Expected Documents, to replying to inquiries about out-of-scope documents, everything moves quickly and dynamically. 2. Publicly disclosed Anonymization Reports available through the EMA portal indicate various approaches to clinical data anonymization. ⚖ - Some sponsors use a qualitative assessment, some use quantitative risk measurement, some use both. Which one do you think is best? 3. Commercially confidential information (CCI) remains a vague and subjectively grey area. 💰 - While we've developed a process that work very well, the strategy for protection of sensitive company data is still one of the most common and first questions that we get asked by clients.

European Medicines Agency (EMA) has officially released the 2nd version of the draft 𝐆𝐮𝐢𝐝𝐞𝐥𝐢𝐧𝐞 𝐨𝐧 𝐪𝐮𝐚𝐥𝐢𝐭𝐲, 𝐧𝐨𝐧-𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐚𝐧𝐝 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐫𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬 𝐟𝐨𝐫 𝐢𝐧𝐯𝐞𝐬𝐭𝐢𝐠𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐚𝐝𝐯𝐚𝐧𝐜𝐞𝐝 𝐭𝐡𝐞𝐫𝐚𝐩𝐲 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬 𝐢𝐧 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥𝐬. 📝✨ To access the document and review the guidelines, click here: https://lnkd.in/d_zAX3GU Additionally, if you're curious about the overview of comments received on the 1st draft of this Guideline, you can check out the details here: https://lnkd.in/dT4k9QeG Let's work together to ensure the highest standards of quality and safety in medical products! 💊💪 #ATMP #EMA #MedicalGuidelines #QualityControl #SafetyFirst ✅🔬

2023 was a landmark year for the FDA's Center for Drug Evaluation and Research (CDER) division, as they approved a significant number of novel drugs. These advancements promise new horizons in patient care and treatment options across various conditions. An impressive lineup of novel drugs received approval, emphasizing the industry's focus on cutting-edge research and development. These approvals span a wide range of therapeutic areas, underscoring the FDA's commitment to addressing unmet medical needs and enhancing quality of life. The momentum in drug approvals sets a promising tone for continued innovation and patient-centric healthcare solutions. #Regulatory #HealthcareInnovation #FDAApprovals2023 #PatientCare #MedicalBreakthroughs #regulatorysubmissions Advancing Health Through Innovation: New Drug Therapy Approvals 2023: https://lnkd.in/gEy4dhBU

Does the FDA's Breakthrough Therapy Designation Program work to speed up drug development? In 2012, the Food and Drug Administration created the breakthrough therapy designation (BTD) program to expedite drug development and review processes. In the July issue of Health Affairs, Kathleen Miller of the Department of Health and Human Services and her team of coauthors explore the impacts of the BTD program on time spent in late-stage clinical development. The researchers conclude that the BTD program was associated with 30 percent faster late-stage development time. These findings suggest that regulatory policies could play an important role in shaping the drug-development process and expediting access to critical medications. For more on the paper’s findings, listen to an upcoming episode of A Health Podyssey with coauthor Jennifer Kao and Health Affairs Editor-in-Chief Alan Weil. Read the full article: https://bit.ly/3W1fdmB

The deadline to transition from the Clinical Trials Directive to the Clinical Trials Regulation (CTR) is approaching on January 30, 2025. Is your organization prepared? Our latest blog breaks down what you need to know, its impact to Sponsors, and how to navigate this transition smoothly. Don’t wait—start preparing today: https://loom.ly/2xJD6TU #ClinicalTrials #CTR #EMA #Regulations #Pharma

Delays caused by regulatory hurdles are preventing patients from accessing drugs that could save their lives. It is critical that biopharma and diagnostic providers have the necessary tools to navigate the regulatory requirements and accelerate approvals. Covering everything from LDT updates, IVDR, reimbursement and more, this summit is your chance to stay ahead of the curve and listen to the thought leaders who are sharply navigating confusing regulatory requirements; download the brochure below to see this comprehensive agenda, where you can learn from the leaders, collaborate, and improve your regulatory strategies: https://ter.li/3ahhpw This is free to attend (see t&c) for academics and drug developers. For service providers in the space - you can save over $200 if you register before this Friday (17th)! Here is a sneak peak at some of our top industry leaders: Jai Pandey, PhD, Vihanga Pahalawatta, Lori Roadcap, Andrea Renninger, Claudia Dollins, Mary J. Savage, Deb Rasmussen, Ralph Riley, Dun Liang, Andrew L'Huillier, Sid Mathur, Qing Li, MD. PhD, Kaska (Katarzyna) Kowanetz, PhD, RAC, Brian Baker and more Download the brochure here: https://ter.li/3ahhpw

After nearly 14 years of draft guidance, the #FDA published the final guidance for industry on Pharmacokinetics in Patients with Impaired Renal Function 📝 ❗ In this edition of the New Medicines, Novel Insights newsletter, Parexel regulatory experts discuss the history and evolution of the FDA's approach in this field and provide five specific areas to consider in the assessment of draft to final guidance. Bring innovative therapies to patients more efficiently and effectively. Read the article below and subscribe to receive the latest #NovelInsights weekly! #Pharmacokinetics #Regulatory #RegulatoryAffairs #WithHeart

After nearly 14 years of draft guidance, the #FDA published the final guidance for industry on Pharmacokinetics in Patients with Impaired Renal Function 📝 ❗ In this edition of the New Medicines, Novel Insights newsletter, Parexel regulatory experts discuss the history and evolution of the FDA's approach in this field and provide five specific areas to consider in the assessment of draft to final guidance. Bring innovative therapies to patients more efficiently and effectively. Read the article below and subscribe to receive the latest #NovelInsights weekly! #Pharmacokinetics #Regulatory #RegulatoryAffairs #WithHeart

After nearly 14 years of draft guidance, the #FDA published the final guidance for industry on Pharmacokinetics in Patients with Impaired Renal Function 📝 ❗ In this edition of the New Medicines, Novel Insights newsletter, Parexel regulatory experts discuss the history and evolution of the FDA's approach in this field and provide five specific areas to consider in the assessment of draft to final guidance. Bring innovative therapies to patients more efficiently and effectively. Read the article below and subscribe to receive the latest #NovelInsights weekly! #Pharmacokinetics #Regulatory #RegulatoryAffairs #WithHeart

The Food and Drug Administration (FDA) recently published draft guidance on the use of real world evidence (RWE) for medical devices. This guidance follows the earlier recommendations to the industry on the use of RWE for biological products published in August 2023. These guidance documents indicate both the importance of RWE to support regulatory approvals, but also the increase in its use cases. As part of a series on real world evidence for regulators, Our RWE experts have highlighted a few key areas about the recent medical device guidance making it clear that RWE is positioned as a useful tool to support with device innovation. Read more at https://buff.ly/49DKGRj and reach out to contact@lumanity.com to speak with one of our experts to learn more on how to prepare for FDA discussions on RWE and how Lumanity’s integrated approach can help you manage all aspects of FDA engagement. Comment below with any suggestions for future RWE topics you would like to see from us! #realworldevidence #rwe #FDAguidance #FDA #regulatoryapproval #clinicaltrials #machinelearning #patientexperience