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Join our insightful webinar exploring the latest developments in the EU medical device vigilance landscape, with industry-renowned specialist Veronika Valdova. Learn how to seamlessly integrate medical devices into your pharma portfolio, gain practical strategies for navigating regulations, and establish robust management processes.
Key topics include:
• Introduction to Medical Device Regulatory Requirements
• Addressing Practical Challenges
• Key Takeaways
• Q&A Session
🎯 This webinar is ideal for:
• MedTech company leaders in acquisition by pharma
• Pharma company leaders expanding their portfolio to include device products.
For any questions about this webinar, or if you would like to request the recording, please write to: contact@qinecsa.com. Enjoy!
The eDRLS training modules deliver essential expertise for navigating FDA's electronic Drug Registration and Listing System.
The content provides step-by-step guidance for accurate, compliant submissions through CDER Direct. The resources combine regulatory requirements with real-world applications, featuring practical case studies and compliance frameworks that streamline your submission process.
Speeding therapies to market requires more than faster development; it demands a smarter regulatory strategy. This eBook explores how life sciences organizations are leveraging expedited regulatory pathways, reliance procedures and global regulatory collaborations to accelerate approvals while maintaining regulatory rigor. Learn how FDA, EMA and PMDA accelerated pathways are being used in practice, how reliance models and consortia initiatives can support global submissions, and why regulatory intelligence is critical for navigating evolving requirements and bringing innovative therapies to patients faster.
Fix formatting issues in Word documents and reduce rework across your team.
OnStyle combines structured authoring, configurable standards, and automated validation.
Fix formatting issues in Word documents and reduce rework across your team.
OnStyle combines structured authoring, configurable standards, and automated validation.
Fix formatting issues in Word documents and reduce rework across your team.
OnStyle combines structured authoring, configurable standards, and automated validation.
Inconsistent formatting, hidden errors, and manual checks cost time, create rework, and increase risk.
OnStyle automatically identifies and fixes formatting issues in Word, while enforcing your standards in the background.
Less rework. Faster approvals. More compliant documents.
All too often documents are formatted inconsistently and contain errors. Your team follows standards—but enforcing them costs time, rework, and approvals... Until now. Meet OnStyle. OnStyle automatically identifies and corrects issues in Word documents. And, when creating new documents, it helps by applying standard styles and formatting rules... Reduce risks, speed up your process, and create compliant documents. Try OnStyle for free and claim your 26% discount while available.
A small biotech needed an informed consent form (ICF) for an IND submission, with limited lead time following agency feedback. The challenge was compounded by a lack of prior materials and an untested template.
Synterex’s Solution:
AgileWriter™ was pretrained using draft sources and updated incrementally as new protocol information became available. The model’s output was so robust it was also leveraged to produce a pregnant partner ICF for the same study.
A medium-sized biotech faced a tight deadline: a comprehensive Clinical Study Report (CSR) shell and first draft were needed in just two weeks, compared to the industry norm of six or more. The project was further complicated by complex oncology study design and data in less-than-ideal formats.
Synterex’s Solution:
Leveraging AgileWriter™, Synterex trained an AI model in real time, mapping planned content to a CSR template and SDTM datasets. As new information arrived, the model was incrementally refined, with a medical writer overseeing the process to ensure quality and compliance.
Singapore has officially begun the transition to the electronic Common Technical Document (eCTD), a major step toward a more streamlined regulatory environment in the Asia-Pacific region. Key milestones include test submissions starting now, with full acceptance of eCTD dossiers from Q2 2026. The initial launch will cover new drug applications, generic drug applications, and drug master file applications.
Download our flyer to explore the key highlights and see how Asphalion can support your transition with expert eCTD services.
If you require any assistance, you can contact us at info@asphalion.com
Digital tools in pharmacovigilance are increasingly valued for their transformative potential. Integrating these tools requires a strategic approach merging technological capability with regulatory compliance.
The eDRLS training modules deliver essential expertise for navigating FDA's electronic Drug Registration and Listing System.
The content provides step-by-step guidance for accurate, compliant submissions through CDER Direct. The resources combine regulatory requirements with real-world applications, featuring practical case studies and compliance frameworks that streamline your submission process.
Remote patient monitoring (RPM) is an excellent opportunity to create accessible healthcare that can not only enhance patient outcomes but also drive down strain and costs on the healthcare industry. Creating an RPM solution that communicates seamlessly and protects patient data can be a challenge, however, which is why KORE developed Connected Health Telemetry solutions for secure, encrypted communications that connect patient to provider.
Download the eBook, “Improving Patient Outcomes and Expanding Healthcare Access” to learn:
- The market and benefits of remote patient monitoring
- Key challenges and how to overcome them
- How KORE helped a Dexcom quickly launch an RPM solution
If you’re an emerging biotech or commercial-stage pharma company evaluating your CRM roadmap, this decision can shape your success across Medical, Commercial, and Patient Services functions.
Rather than asking “Which is better?”, consider asking:
-How tightly integrated is CRM with our content, regulatory, and data systems?
-Do we need a platform that supports both field teams and patient services?
-What level of flexibility do we need for omnichannel, AI, and future expansion?
-Who owns CRM administration and configuration—internal teams or managed services?
-What’s our timeline for go-live, and do we need to start simple or scale quickly?
These are the kinds of questions we help clients answer every day.
At Project Outlier, we offer an independent CRM Assessment to help life sciences teams evaluate their options clearly, with practical guidance on compliance, scalability, cost of ownership, and cross-functional needs.
Let’s talk. If you're deciding between Veeva and Salesforce, we’ll help you pick the platform that fits your roadmap.
Click here to book a free discovery call with our VP of Consulting Services, Erin Walter: http://bit.ly/3SOE1Np
How confident are you that your organization has the right technology in place to support the journey from IND submission to commercialization?
Very confident? Somewhat confident? Not confident at all?
We can help!
Download our FREE Clinical Tech Stack Blueprint to get started on building out your systems to scale all the way from IND submission to Phase 3 trials:
How confident are you that your organization has the right technology in place to support the journey from IND submission to commercialization?
Very confident? Somewhat confident? Not confident at all?
We can help!
Download our FREE Clinical Tech Stack Blueprint to get started on building out your systems to scale all the way from IND submission to Phase 3 trials: https://lnkd.in/eYxPc6Mj
Not all trial finders are created equal. Study aggregate websites may seem patient-friendly, but they often introduce more risk than reward—for both patients and sponsors. Focusing on your own studies isn’t just safer; it’s smarter.
Download this report and uncover:
- Why sponsor-specific trial finders offer a more trustworthy, patient-centric experience
- The hidden risks of multi-sponsor aggregator platforms
- How leading sponsors are setting a new standard in trial discovery and engagement
If you're doing all the right recruitment outreach but your pre-qualified referrals are falling into a black hole and not converting into randomizations, this webinar is for you. Tune in as Gilead, Epic Medical Research, and ProofPilot unpack the complexities of the last mile of recruitment.
Playing phone tag is an unpaid, patient recruitment time-suck, draining up to 40 hours of sites’ precious time each week. 📞🏃♂️ Think about what freeing up 40 hours could do!
How do we give that time back to sites? Can we make things smoother for the patient, while we’re at it?
Technology can certainly help. ProofPilot’s automatic call scheduler eliminates the back and forth between sites and patients, reducing patient drop-off and increasing conversions.
Ready for a deep-dive? Read our white paper to see how this technology transformed referrals for 42 sites!
Site training holds a necessary place in clinical research, but the current framework lacks certain elements, hindering the true goals of successful training. What lessons can we draw from other industries that have demonstrated excellence and efficiency?
Imagine instead an alternative approach to ensuring quality conduct at the site that:
- Minimizes complexity and ambiguity with consistent approaches
- Prevents errors with highly-responsive, real-time feedback
- Takes the detective work out of finding information
- Fits the unique needs of site staff while also meeting compliance requirements
Read our latest white paper to explore a fresh take on site training that delivers on this imagined experience!
Evernorth® Health Services, collaborating with a contract research organization (CRO), performed direct-to-patient outreach to recruit patients for a pediatric vaccine trial to support a pharmaceutical sponsor. An incredible 700,000+ eligible patients within the age range were initially identified. After applying advanced analytics to narrow down to those most likely to qualify, households with multiple children were consolidated to maximize outreach efficacy.
Regulatory submissions are complex, but drafting them doesn’t have to be. What if you could generate structured, submission-ready content at the click of a button?
What You’ll Learn:
- How automation accelerates submission preparation – Reduce time spent on drafting and iteration from months to minutes
- How AI-powered templates enhance content generation – Instantly produce narratives, tables, and lists beyond static document structures
- How Weave simplifies regulatory workflows – Automate key steps from planning to publishing for greater efficiency and accuracy
- What’s next for Weave – Expanding support for clinical-phase filings, including CSRs, protocols, and annual reports
KORE and JACS Solutions have developed a trusted, long-standing relationship with each providing strong service and solution offers that simplify the complexities of IoT.
For KORE, one of the primary hardware elements it offers its connected health customers is a USB modem that plugs into at-home cardiac rhythm monitoring devices to enable cellular connectivity.
OEM devices have limited shelf lives, which can lead to integration issues and continuity of services. For JACS Solutions, when their customers purchase hardware but need services such as connectivity, connectivity management, network monitoring, lifecycle management, or forward and reverse logistics they turn to KORE.
Medical Guardian is a leading provider of personal emergency response systems (PERS) and innovative health solutions for aging adults, with 600,000+ active members in all 50 states. The company offers a full suite of connected-care medical alert systems that empower older adults to live a life without limits and age safely at home.
KORE OmniSIM™ technology provides Medical Guardian the flexibility to wirelessly switch to a network carrier that best meets members’ specific needs. This revolutionary technology is designed to overcome cell signal challenges and address healthcare access disparities by enabling electronic switching of service carriers for optimal 24/7 connectivity.
The opioid crisis remains a pressing public health concern, with nearly 87,000 drug overdose deaths reported in 2024. Although this reflects a slight improvement compared to previous years, the impact continues to vary across states, West Virginia, in particular, continues to grapple with severe challenges.
In a bold effort to address these issues, VeeOne Health, Social Mobile, and KORE have formed a pioneering partnership to support drug control initiatives in the state. Their collaborative approach has led to the deployment of an innovative solution designed to lower relapse rates among individuals recovering from substance use disorder (SUD), offering renewed hope in the fight against addiction.
Discover how a pharmaceutical company leveraged advanced analytics to streamline site selection for a Phase III oncology trial, ensuring efficient patient recruitment and high-quality data collection. Learn how integrating patient demographics, investigator profiles, and social determinants of health can enhance trial outcomes and accelerate drug development.
🕒 Multiple time slots:
Americas: 6am | 10am | 2pm EDT
Europe: 12pm | 4pm | 8pm CET
⏳ Duration: 30 minutes
What To Expect:
Join us for a focused and dynamic 30-minute session where our expert speaker dives into the latest advancements in pharmacovigilance literature screening:
✓ Gain expert insights into literature screening processes
✓ Leverage AI and automation
✓ Discover practical solutions to industry pain points
✓ Learn about emerging trends shaping the future of pharmacovigilance
✓ Q&A to address your specific questions
About The Speaker:
✓ 20+ years in clinical practice & pharmacovigilance
✓ Experienced in literature screening solutions
✓ Skilled client partner
Register Now
Can't make it? Request the recording
FDA CDER Small Business and Industry Assistance (SBIA)
The primary goal of this clinical investigator training course is to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care.
Participants will acquire a practical understanding of:
- FDA’s approach to trial design
- Statistical issues in the analysis of trial data
- Safety concerns in the development of medical products
- Understanding preclinical information relevant to medical product development
- Clinical investigator responsibilities
Register here ➡️ FDA Clinical Investigator Training Course (CITC) 2024 - 12/10/2024 | FDA
FDA CDER Small Business and Industry Assistance (SBIA)
This webinar will discuss the clinical pharmacology considerations for the development of novel therapeutic modalities. Our FDA subject matter experts will also address the unique considerations for oligonucleotide therapeutics and antibody-drug conjugates with respect to topics such as dose selection, exposure/response analysis, organ impairment, drug interactions, QTc assessment, and immunogenicity.
Register here ➡️ Clinical Pharmacology Considerations for Novel Therapeutic Modalities - 12/04/2024 | FDA
FDA CDER Small Business and Industry Assistance (SBIA)
This webinar will provide an update and overview on the final M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms guideline including major changes from the draft guideline and FDA’s current bioequivalence (BE) guidance, delineate FDA’s planning on the implementation of M13A, and address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline.
Register here ➡️ M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance - 11/21/2024 | FDA
FDA CDER Small Business and Industry Assistance (SBIA)
This webinar will discuss the final guidance for the industry Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies which was published in July 2024.
Our FDA subject matter experts will also address recommendations from the guidance including, deciding whether and when to conduct the study, as well as how to design and report results from a human radiolabeled mass balance study.
Earn 1.0 CME/CPE/CNE!
Register here ➡️ Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies - 11/12/2024 | FDA
FDA CDER Small Business and Industry Assistance (SBIA)
This webinar aims to inform stakeholders, particularly those who design, implement and assess risk evaluation and mitigation strategies (REMS), on the recently published guidance REMS Logic Model: A Framework to Link Program Design With Assessment.
This activity is intended to provide an overview of the REMS Logic Model, including its methodological underpinnings and proposed use.
Register here ➡️ Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation - 11/07/2024 | FDA
FDA CDER Small Business and Industry Assistance (SBIA)
The primary goal of this clinical investigator training course is to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care.
Register here ➡️ FDA Clinical Investigator Training Course (CITC) 2024 - 12/10/2024 | FDA
Prior to the FD&C Act, pharmaceutical companies were not required to provide proof of drug safety or a disclosure of all active ingredients. Since then, all new drugs undergo an intensive review process by the Food and Drug Administration (FDA), and ever-evolving guidance and regulations ensure that both new drugs and those with updated characteristics, such as dosing, delivery, and expanded indications, are safe and effective for the intended populations. A gap remains, however, for drug investigations including and targeted for children of varying ages.
Download and read now for more insights!
Innovative development of human drugs, biologics, and medical devices (medical products) and their quick advancement through the United States Food and Drug Administration (FDA) approval pipeline is necessary to improve the lives of patients. It is also imperative for sponsors to consider diversity when enrolling study participants throughout the clinical development pipeline to adequately represent the population of patients who have a disease or condition.
Download and read now for more insights!
This white paper will explore the business benefits and case of using the FACTS simulation software for all your clinical trial designs.
Mark your calendars for September 26th and join us at the Novartis Campus in Basel for the Insife Annual Convention - your calendars for September 26th and join us at the Novartis Campus in Basel for the Insife Annual Convention - Connect. Collaborate. Community.ect. Collaborate. Community.Mark your calendars for September 26th and join us at the Novartis Campus in Basel for the Insife Annual Convention - Connect. Collaborate. Community.
Join us for Part 2 of our webinar series on post-marketing safety surveillance, where we dive deeper into the intricate world of medical devices and drug-device combination products.
Building upon the foundation set in Part 1, this session explores the reporting essentials and obligations associated with the post-marketing safety surveillance of these products in both the EU and USA markets. Industry expert Veronika Valdova will guide you through current trends and challenges in the industry, offering valuable insights into best practices and regulatory expectations. Attendees will gain a comprehensive understanding of how to navigate the complexities of safety surveillance and ensure compliance with international standards.
Agenda:
- Introduction Drug-Device and Combination Products.
- Types of DDCs in Europe and the U.S.
- Reporting Essentials and Obligations
- Essential Procedures to Cover
- Comparison of Reporting Requirements in the EU vs the U.S.
- Current Trends and/or Challenges
- Best Practices
- Key Takeaways
- Q & A Session
For any questions about this webinar, or if you would like to request the recording, please write to: contact@qinecsa.com. Enjoy!
Join our insightful webinar exploring the latest developments in the EU medical device vigilance landscape, with industry-renowned specialist Veronika Valdova. Learn how to seamlessly integrate medical devices into your pharma portfolio, gain practical strategies for navigating regulations, and establish robust management processes.
Key topics include:
• Introduction to Medical Device Regulatory Requirements
• Addressing Practical Challenges
• Key Takeaways
• Q&A Session
🎯 This webinar is ideal for:
• MedTech company leaders in acquisition by pharma
• Pharma company leaders expanding their portfolio to include device products.
For any questions about this webinar, or if you would like to request the recording, please write to: contact@qinecsa.com. Enjoy!
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