- AI in PV
- AI Implementation
- AI Training
- AI Compliance
- Regional Coverage
- Expertise
- QPPV Services
- Medical Safety
- Aggregate Reports
- Signal and Risk Management
- Audits and Due Diligence
- Training and Consultancy
- Digital Transformation
- Technology
How do you strengthen a system which complies both with regulatory and industry standards? Our team of senior pharmacovigilance experts will show you how to construct functional systems with ingenuity.
Review of existing pharmacovigilance processes can make way for positive changes with dramatic increases in efficiency.
The competence of your pharmacovigilance team members is related to your audit and inspection results. To make sure our clients are prepared, we provide all levels of pharmacovigilance training and courses can be customized to meet specific requests.
Review of existing pharmacovigilance processes can make way for positive changes with dramatic increases in efficiency.
Local and regional regulatory authorities are constantly updating safety information which requires reference safety data and labeling to be updated. This is time-consuming for a QPPV. iVigee has created a monitoring solution that performs these tasks.
The QMS is fundamental to all aspects of pharmacovigilance. In addition to building your QMS, we can provide full Quality Management System reviews. If your organization has recently finished an inspection or audit, our QMS services focus on corrective and preventative actions (CAPA) to meet any and all findings from audits or inspections. CAPA(s) are provided, with follow-up until positive corrections are documented and completed.
Standard Operating Procedures (SOP) describe the critical processes within your pharmacovigilance system. At iVigee, we may review your existing SOPs, develop new SOPs, or perform a batch review for multiple/all SOPs in place impacted by new regulations.
The QMS is fundamental to all aspects of pharmacovigilance. In addition to building your QMS, we can provide full Quality Management System reviews. If your organization has recently finished an inspection or audit, our QMS services focus on corrective and preventative actions (CAPA) to meet any and all findings from audits or inspections. CAPA(s) are provided, with follow-up until positive corrections are documented and completed.
This year marked significant strides in AI, with leading regulatory bodies inviting public commentary on their perspectives regarding AI and Machine Learning (AI/ML) in drug development. While the FDA's consultation period concluded earlier in August (find the paper here), the EMA's window remains open until year-end.
Leveraging the latest AI advancements for our clients' benefit. We have thoroughly reviewed both papers and have submitted our comments, contributing to shaping the future of AI in pharmaceuticals.
Replace existing predictive ML-based pipelines with the realities and power of Generative AI? Seize the opportunity to innovate and transform your pharmacovigilance strategies with our cutting-edge Expert AI Implementations.
iVigee is a world-leading technology company that specialises in combining AI, IT, and industry expertise to create simple, powerful, and elegant solutions that revolutionize the field of pharmacovigilance.
Marcela is an experienced PV professional with extensive expertise in the setup, use and management of Pharmacovigilance System Master Files (PSMFs) and is sharing her knowledge and best practices about how to practically manage your own PSMFs.
iVigee 2023 milestones. We 2019ve had a few!
As 2023 draws to a close, it a good time to review some of iVigee 2019 s key successes and look back over what has been a tremendous year of innovation and growth for us, captured in this post 2019s slideshow.
iVigee launches breakthrough iViReg Community subscription package!
Pharmacovigilance professionals can now gain access to our world-leading iViReg platform through a simple online entry-level subscription, allowing them to access core features of iViReg in one easy step.
The iVigee team, comprising of Ken Nordeen, Kane Smith, Jan Petracek, Tereza Cibulova, and Robert Scheiner, participated in the 7th ISoP Boston Seminar on Intelligent Automation.
Landmark EU Regulation points to implications for AI in Pharmacovigilance!
The European Union reached an important milestone on Saturday with its proposed regulation of Artificial Intelligence. The EU AI Act comes after intense discussions with EU Member States and the European Parliament, with approval scheduled in Spring 2024 and the act coming into force in 2026. The importance of this comes from what is known as the 2018Brussels Effect 2019, where European changes may inspire global shifts in AI governance.
Complexity and Priorities - Explaining AI in Pharmacovigilance.
Understanding the relevance of AI and Large Language Models (LLMs) like GPT-4 within pharmacovigilance can be difficult, but the key is to demystify their complexity and prioritize explanation.
ISoP Intelligent Automation Seminar - few spots left to register!
Our CEO Jan Petracek and CIO Robert Scheiner will be presenting at the 7th Intelligent Automation in Pharmacovigilance Seminar, hosted at the Biogen Cambridge Campus on the 4th and 5th of December in Boston. Explore the future of pharmacovigilance!
We are proud to be exhibiting at booth D5 at this year’s DIA Europe conference in Brussels from the 12th to the 14th of March. And we’ll be demonstrating our thought leadership from the top with CEO Jan Petracek co-chairing the Wednesday 13th track 07 Pharmacovigilance and Safety session - How to build a sustainable Pharmacovigilance Ecosystem?
Generative AI can be deployed in various processes such as monitoring data sources and case intake, managing safety signals and risks, analysing complex data, reporting adverse events, improving submissions and compliance, and providing training, education, and patient support.
By making Generative AI and LLM technologies central to our strategy, we ensure that your business is not only keeping pace but also setting the standard for AI-driven pharmacovigilance solutions. The AI revolution at the enterprise level necessitates a cultural shift, and we recognize that the newly introduced business processes, more robust infrastructure, real data readiness, and having the right talent all require a well-considered change-management approach.
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