- 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.
Author: Robert Scheiner, CIO, iVigee
Pharmacovigilance Transformation...find out what is changing and what will stay at the 2024 European Federation for Pharmaceutical Sciences (EUFEPS) annual meeting.
We're thrilled to announce that Lucia Matejkinova joined iVigee as our new QPPV Office Lead on March 1, 2024! She oversees the management of our QPPV office and serves as the EU QPPV for our clients.
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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