Quality & Compliance
Safety & Vigilance
08 november 2023
Electronic Product Information (ePI) is a transformative solution reshaping the healthcare and pharmaceutical industries by digitalizing Product Information (PI) traditionally found on printed labels and package inserts. It offers comprehensive, easily accessible, and up-to-date information about medicines and healthcare products, benefiting stakeholders across the healthcare ecosystem.
In a world where digital transformation is ever-present, ePI is emerging as a transformative tool, going beyond mere convenience – empowering patients and healthcare providers with vital medication information. This information enhances their understanding of treatments, potential side effects, and interactions, ultimately ensuring safer and more effective healthcare.
Patients now have enhanced accessibility to vital medication information, bridging the gap between prescription and understanding. It empowers patients to make informed decisions, leading to a safer and more efficient healthcare system.
For healthcare providers, ePI streamlines their services, enabling them to make well-informed decisions during patient consultations. The result significantly reduces the risk of medication errors, making healthcare services more efficient and safer.
Pharmaceutical companies leverage ePI for enhanced communication and engagement with healthcare providers and patients. This digital platform enables companies to provide timely updates, safety alerts, and educational content directly to healthcare professionals and consumers. The result is a stronger sense of trust and loyalty, ultimately benefiting patients and healthcare providers.
As we step into the digital age of healthcare, it’s essential to highlight the pivotal role played by the Product Lifecycle Management (PLM) Portal and the pilot phase of ePI.
The PLM Portal serves as the digital hub where electronic product information is created, updated, and managed. It ensures that accurate and up-to-date information is readily available to all stakeholders, making ePI an integral part of the healthcare landscape.
The pilot phase of ePI is a crucial step in this digital transformation. It involves real-time regulatory procedures for limited applications in centralized, European, and purely national procedures. Participating authorities include the European Medicines Agency, the Danish Medicines Agency, the Dutch Medicines Evaluation Board, the Spanish Agency for Medicines and Health Products, and the Swedish Medical Products Agency. The pilot phase is essential in fine-tuning the integration of ePI into healthcare practices.
While the advantages of ePI are evident, it’s equally important to recognize the challenges that come with its implementation:
Technical Infrastructure: The transition to ePI necessitates a significant investment in digital infrastructure. Companies must have robust digital systems to support ePI delivery and updates.
User Adoption: Encouraging healthcare providers and patients to embrace ePI fully may pose challenges. Healthcare professionals, especially those who have been in the field for many years, might be resistant to change. Effective strategies for user adoption are essential to navigate this challenge successfully.
Standardization: Developing and maintaining standardized ePI formats across regions and platforms can be complex. Achieving standardization is critical to ensuring that information remains universally accessible and understood.
PLG is dedicated to closely monitoring updates from the European Medicines Agency (EMA) and the PRM portal to ensure our clients are well informed and prepared to navigate the evolving landscape of electronic Product Information (ePI). We offer comprehensive support in the following areas:
Regulatory Compliance: PLG partners with clients to keep them abreast of dynamic regulatory requirements concerning ePI. We work diligently to ensure that our clients’ electronic product information remains fully compliant and aligns seamlessly with the ever-changing industry standards.
Data Security: Recognizing the importance of data security and confidentiality in healthcare, PLG employs robust security measures. We are committed to safeguarding sensitive healthcare information and maintaining strict compliance with data protection regulations, providing peace of mind to our clients.
Quality Control: PLG delivers rigorous quality control and validation services to guarantee the accuracy and consistency of electronic product information. Our meticulous approach significantly reduces the risk of errors or misinformation, instilling trust and confidence in the data provided.
Customized Solutions: At PLG, we understand that each client has unique needs and objectives. We tailor our services to match each client’s specific requirements, ensuring that the implementation of ePI aligns seamlessly with their goals and operations.
Support and Maintenance: PLG’s commitment to our clients extends beyond implementation. We offer ongoing support and maintenance services, ensuring that ePI systems remain operational, efficient, and error-free. Our dedicated team is ready to troubleshoot and address any issues promptly, helping our clients maintain a smooth, uninterrupted digital healthcare environment.
In conclusion, PLG is your trusted partner in embracing the transformative power of ePI. We provide steadfast support in regulatory compliance, data security, and quality control and offer customized solutions to meet your unique needs. Our commitment to supporting and maintaining ePI systems ensures that the benefits of this digital evolution are fully realized, driving safer and more efficient healthcare practices while fostering stronger relationships between pharmaceutical companies and healthcare providers. The possibilities are vast, and the benefits are undeniable.
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