title: Aims and approaches of Web-RADR: a consortium ensuring reliable ADR reporting via mobile devices and new insights from social media.
abstract: BACKGROUND
  Advent of new technologies in mobile devices and software applications is leading to an evolving change in the extent, geographies and modes for use of internet. Today, it is used not only for information gathering but for sharing of experiences, opinions and suggestions. Web-Recognizing Adverse Drug Reactions (RADR) is a groundbreaking European Union (EU) Innovative Medicines Innovation funded 3-year initiative to recommend policies, frameworks, tools and methodologies by leveraging these new developments to get new insights in drug safety.
  
  
  METHODS
  Data were gathered from prior surveys, previous initiatives and a review of relevant literature was done. New technologies provide an opportunity in the way safety information is collected, helping generate new knowledge for safety profile of drugs as well as unique insights into the evolving pharmacovigilance system in general. It is critical that these capabilities are harnessed in a way that is ethical, compliant with regulations, respecting data privacy and used responsibly. At the same time, the process for managing and interpreting this new information must be efficient and effective for sustenance, thoughtful use of resources and valuable return of knowledge. These approaches should complement the ongoing progress toward personalized medicine.
  
  
  CONCLUSIONS
  This Web-RADR initiative should provide some directions on 'what and how' to use social media to further proactive pharmacovigilance and protection of public health. It is expected to also show how a multipronged expert consortium group comprising regulators, industry and academia can leverage new developments in technology and society to bring innovation in process, operations, organization and scientific approaches across its boundaries and beyond the normal realms of individual research units. These new approaches should bring insights faster, earlier, specific, actionable and moving toward the target of AE prevention. The possibilities of a blended targeted pharmacovigilance (PV) approach where boundaries between stakeholders blur and cultures mix point to very different future for better, healthier and longer lives.
authors.affiliation: a 1 Novartis Pharmaceuticals , 1 Health Plz, 339.1130, East Hanover, NJ 07936, USA +1 862 778 7904 ; Rajesh.ghosh@novartis.com.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Ghosh
authors.affiliation: b 2 Novartis , Basel, Switzerland.
authors.forename: David
authors.initials: D
authors.lastname: Lewis
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000941:ethics / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D020407:Internet; D060735:Pharmacovigilance; D000068997:Smartphone; D061108:Social Media
keywords: Innovative Medicines Innovation; mobile reporting; real-time data; social media