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SP0167 EMA and EULAR: Can We Combine Our Efforts in a More Efficient Way; What the Future Holds?
  1. R. Veselý
  1. Rheumatology, Respiratory, Gastroenterology and Immunology Office, European Medicines Agency, London, United Kingdom

Abstract

The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995.

The mission of the European Medicines Agency is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health.

The Agency is responsible for the scientific evaluation of applications for European Union (EU) marketing authorisations for human and veterinary medicines in the centralised procedure.

Among other tasks the Agency plays a role in stimulating innovation and research in the pharmaceutical sector:

  • it gives scientific advice to companies on the development of new medicines;

  • it publishes guidelines on the requirements for the quality, safety and efficacy testing of medicines;

  • it provides special assistance to micro, small and medium-sized enterprises (SMEs) through its SME office;

  • it issues opinions on for medicines for rare diseases.

Contacts between EULAR and EMA have been developed on several levels (CHMP, RIWP, PDCO); on both individual members' and institutional level; for different EMA activities, i.e.

  • Regular attendance of European regulators at the annual EULAR congress and other EULAR events

  • Engagement in the context of the development of the Lupus guideline: session at EULAR 2013 in Madrid introducing the draft guideline.

However, mutually beneficial interaction has not been used to its full potential.

Transparent interaction with all stakeholders including health care professionals, patient organisations, learned societies and academia in general are among our priorities in order to use state-of-art knowledge and expertise in the field in our evaluations and recommendations and to support research and innovation to stimulate the development of better medicines. We value the contribution of our partners and stakeholders to our work.

The opportunities for further expansion of EMA/EULAR collaboration will be discussed.

Disclosure of Interest None declared

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