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In an industry as complex and measured as pharmacovigilance, “change” is a dreaded word. Years are spent in putting up processes, tools and software in compliance with different regulations. Thus, safety systems stay in place, no matter how obsolete they become with the evolution of technology.
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In an increasingly outsourced and virtual workforce environment, the need for more effective and easier collaboration is accelerating adoption of cloud technologies. Seamlessly incorporating internal and external parties into end-to-end processes and providing a single source of safety data and content is driving efficiencies while improving compliance and global visibility.
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In this session, we will discuss how an effective signal detection process should be based on a multidisciplinary and heterogeneous approach including implementation of precision methodologies where applicable.
We will also briefly discuss about the best practices and increasing trends of precision methodologies specific to product types.
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Providing flexible workflows and access to all parties, modern solutions are transforming safety with collaborative and streamlined processes. Companies can manage the entire ICSR reporting lifecycle, having full visibility and traceability from collected to submitted cases. With always current safety data, pharmacovigilance teams can perform continual benefit-risk evaluation and improve decision-making and compliance.
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The life sciences industry is rapidly moving towards Precision Medicine: individualized treatments and disease interventions that treats patients based on their unique genomic characteristics across therapeutic areas.
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The world has been dreaming of self-driving cars for over a century. Unimaginable to the average person even 10 years ago, today most developed countries are working on laws to regulate them. Though we might still be a few years away, safety case processing and signal management are also on their way to running in auto-pilot mode and this is good news for your safety teams.
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Arriello’s Vanessa Fachada and Kamila Erbanova discuss how COVID-19 has accelerated the move towards remote auditing now being the default going forward, how to plan and prepare for remote auditing, and their top 10 tips for making the remote audit process smooth and efficient for both auditors and auditees.
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Adverse Event (AE) collection, assessment and reporting is a foundational activity of Sanofi’s pharmacovigilance and license to operate. With over 600,000 AE cases expected this year, it is also an intensive, manual, expensive, and time-consuming activity. In this webinar, hear how Sanofi has demonstrated success with case processing automation via natural language processing, machine learning and artificial intelligence with Deloitte’s ConvergeHEALTH Safety Cognitive Platform. Hear how they have realized significant operational and scientific benefits by using cloud-based automation technology.
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There is rising pressure to move from reactive to proactive and predictive pharmacovigilance. With a comprehensive view into relevant information from intake to post-market surveillance, companies can better mitigate risks and make benefit-risk safety decisions.
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Decreasing budgets and increasing case volumes require a more efficient model in drug safety. Is automation part of that model? A recent survey conducted by a global consultancy found that workflow automation is rated as the most critical buying factor when large biopharmas are choosing safety software. Despite the many bold claims around automation in the industry, few have any real-world proof points to support them.
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Medical information call centers have an opportunity to transform the way they capture, code, and analyze adverse events (AEs) and product quality complaints (PQCs) with artificial intelligence (AI) and automation.
The use of such innovative technology improves data quality and consistency, compliance, and operational efficiency. It helps reduce the frequency of your pharmacovigilance (PV) operations resources going home, saying, “I have more to do at the end of the day than I did when I started.”
Please join us for a one-hour webinar, in which you will learn how you can use AI and automation to turbo-charge your end-to-end PV system. Use cases and demonstrations will include:
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For safety organizations to be strategic, companies need to invest in safety science and increase its cross-functional role. Leveraging modern technologies and redefining processes to enable seamless collaboration between departments from preclinical to commercial, can drive greater impact from safety science.
Join us as we discuss how the role of safety science evolves as companies grow, different PV organizational models, how technology can improve, and measuring the value of safety science.
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Managing safety cases is becoming more complex due to ever-increasing volume and variety of data. These common but evolving challenges point to the development of common frameworks leading to industry-wide solutions that can be adapted or tailored to specific needs.
This webcast, co-hosted by Oracle and ICON, will discuss why, from a CRO perspective, the cloud and AI are important milestones on the journey to the new world of safety.
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