Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges, London - Main contents
| date | May 4, 2018 |
|---|---|
| city | London, Great Britain |
| organisation | European Medicines Agency (EMA) i |
The aim of this workshop is to inform thinking on big data and related challenges as the HMA/EMA Joint Big Data Task Force is planning to make recommendations in this field in November 2018. In 2017, the task force undertook detailed landscaping of the entire big data field (genomics through to m-health) as viewed through the lens of the regulator. It also performed online surveys of both national regulatory agencies and the pharmaceutical industry on perspectives, expertise and challenges. This work helped develop an understanding of the challenges and the current state of expertise in the regulatory network. The taskforce now aims to move onto considering solutions. The task force was established in March 2017 to identify the emerging challenges created by the increasing availability of data and related opportunities for supporting regulatory decision-making.
The European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in Amsterdam. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
The EMA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies submit one single marketing authorisation application to the EMA.