- AI in PV
- AI Implementation
- AI Training
- AI Compliance
- Regional Coverage
- Expertise
- QPPV Services
- Aggregate Reports
- Signal and Risk Management
- Audits and Due Diligence
- Training and Consultancy
- Digital Transformation
- Technology
Pharmacovigilance (PV) legislation is built upon the requirement for the continuous monitoring and evaluation of medicinal products to safeguard public health and safety. It comprises a complex framework of laws and regulations, guidelines, and mandates, with a mixture of harmonised global or regional standards, such as European Medicine Agency’s (EMA) Good Pharmacovigilance Practices (GVP), supplemented at the national level with local requirements and differences.
Understanding and adhering to these guidelines is therefore a legal requirement for pharmaceutical companies marketing products, and failure to do so can result in fines, product removal, reputational damage and more, so it is essential that PV personnel are fully trained on what is required, and ready for audits and inspections.
Multi-Level Training: Our courses cater for different knowledge levels, from basic introductions to the principles of pharmacovigilance (PV) and Good Pharmacovigilance Practices (GVP), to advanced, in-depth analyses of specific GVP modules and PV activities.
Practical Application Workshops: We conduct workshops focused on the practical application of GVP guidelines and PV legislation, including case studies and real-world scenarios to enhance understanding.
Guidance on Applicable Legislation: We provide detailed guidance on the legislation relevant to pharmacovigilance activities, including how to interpret and apply these laws in practical settings.
Updates on New and Evolving Legislation: Keeping participants informed about new developments and changes in PV legislation and GVP modules is an important part of ensuring they remain compliant under the latest regulations and expectations.
Review of Existing Training Materials: Analysing the existing pharmacovigilance training materials and documents within your organization to identify areas for improvement and alignment with current GVP guidelines.
iVigee’s GVP training experts have years of direct pharmacovigilance experience with GVP and we are recognised as leaders in this area by organisations such as the Drug Information Association (DIA), where our leadership team are a part of their own GVP training programmes.
We understand that each organization has unique needs, and we offer tailor-made training solutions designed to address that alongside your specific challenges and objectives for a more effective and relevant learning experience. And our range of flexible training options are also designed to suit different learning preferences, including face-to-face sessions, eLearning platforms, and self-study materials, ensuring accessibility for all participants.
Our training not only covers PV legislation and GVP requirements from a global perspective, but we can also introduce insights into regional differences and international standards, making it suitable for organisations operating in multiple jurisdictions. Through our world leading Regulatory Intelligence platform iViReg, we can ensure that all training on local requirements is based on the very latest information available in over 90 countries.
All training participants receive certification upon completion, contributing to their professional development and demonstrating their commitment to maintaining high standards of pharmacovigilance practice.