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What Trends Are Emerging in the Field of Pharmacovigilance Services?

Author: Ddreg Pharma
by Ddreg Pharma
Posted: Dec 01, 2023

Several trends were emerging in the field of pharmacovigilance services, and it's important to note that the landscape may have evolved since then. Here are some of the trends that were prominent at that time:

Advanced-Data Analytics:Pharmacovigilance services in South Koreawere increasingly leveraging advanced data analytics techniques, including machine learning and artificial intelligence, to process and analyze large volumes of data from various sources. These techniques help in identifying potential safety signals more effectively.

Real-world Evidence (RWE): There was a growing emphasis on incorporating real-world evidence, such as data from electronic health records and patient registries, into pharmacovigilance processes. RWE can provide a more comprehensive view of a drug's safety profile.

Digital Health Technologies: The integration of digital health technologies, such as wearable devices and mobile apps, allowed for the collection of real-time patient data. This data can be valuable for monitoring adverse events and assessing the safety of medications.

Social Media Monitoring: Social media platforms were being increasingly monitored for discussions and reports related to adverse drug reactions. This provided an additional data source for pharmacovigilance activities.

Regulatory Changes: Regulatory services were updating guidelines and requirements for pharmacovigilance, including the adoption of the International Council for Harmonisation (ICH) E2E Pharmacovigilance Guidelines. These changes were influencing how pharmacovigilance services operated.

Globalization: With the globalization of pharmaceutical markets, pharmacovigilance services were expanding to cover a broader range of geographic regions and regulatory requirements. This required greater coordination and harmonization of safety reporting.

Patient-Centric Approaches: There was a shift towards more patient-centric pharmacovigilance, involving patients in reporting adverse events and understanding their experiences with medications.

Automation and AI-driven Case Triage: Automation was being used to handle routine tasks, such as case triage and data entry, allowing pharmacovigilance professionals to focus on more complex analyses and decision-making.

Drug-Drug Interactions and Comorbidities: The recognition of the importance of considering drug-drug interactions and comorbidities when assessing the safety of medications was growing. This required more comprehensive data analysis al Regulatory Service.

Data Quality and Standardization: Ensuring data quality and standardization across different sources and regions remained a significant challenge and focus of improvement offering all types of services.

Regulatory intelligence -: plays a crucial role in pharmaceutical decision-making by providing pharmaceutical companies with up-to-date information and insights into regulatory requirements, changes, and trends. It helps them navigate the complex and highly regulated environment of the pharmaceutical industry effectively. Here's how regulatory intelligence contributes to decision-making in the pharmaceutical sector

About the Author

Ddregpharma provides regulatory medical writing and editing services for a wide variety of regulatory documents including patient narratives, Ctd summaries, Csrs, and Investigator Brochures.

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Author: Ddreg Pharma

Ddreg Pharma

Member since: Nov 28, 2023
Published articles: 3

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