ABSTRACT
This year, following the European Medicines Agency (EMA) relocation due to the Brexit process, the 13th Pharmacovigilance Conference organized by Medicines for Europe took place in Amsterdam, the Netherlands. The pharmaceutical industry is usually associated with the development and launch of new drugs for the market, but it is also committed to finding new ways of making existing drugs and processes (e.g., pharmacovigilance [PV]) more efficient and better for patients. In relation to this, a variety of topics were on the agenda at the conference, including updates on the progress of the EudraVigilance (EV) system for monitoring and analyzing potential drug-related adverse events, as well as highlights on the E.U. Network Strategy to 2025 and the EMA multi-annual work program related to big data acceptability, electronic product information (ePI) Key Principles and Roadmap for implementation, and work-sharing ongoing projects for achieving harmonization of requirements and processes. Adrian van den Hoven (Director General, Medicines for Europe) opened the conference looking towards the future, emphasizing what the current PV system needs to do in order to adapt to new landscapes. With big data, robotization, automation or globalization, there are many opportunities to streamline and become smarter on the horizon.
Subject(s)
Adverse Drug Reaction Reporting Systems , Pharmacovigilance , Congresses as Topic , Europe , European Union , Humans , Netherlands , United KingdomABSTRACT
The Drug Information Association (DIA) Europe held its annual meeting from April 17-19, 2018, in Basel, Switzerland. The key topics discussed in the 3-day meeting were related to pharmacovigilance, clinical development, patient engagement, data and data standards, preclinical development and early-phase clinical research, regulatory science, translational medicine and science, and value and access. The program was principally focused on the current opportunities and future landscape of the healthcare system as a result of the increasingly innovative technologies and effective utilization of big data. In addition, the critical need for collaboration and partnership between all the stakeholders of the healthcare system was highlighted. This report covers some of the regulatory sessions presented at the meeting in which regulators, payers, industry and patients presented their perspectives for discussion.
