REAL WORLD STUDIES, CHALLENGES, NEEDS AND TRENDS FROM THE INDUSTRY Batrouni M1, Comet D1, Meunier JP1,  1 Axonal,215 Georges Clemenceau  Objectives: To understand key challenges, needs and trends for conducting real world studies (RWS). Methods: An online survey conducted in September 2013 within key players in the pharmaceutical and medical device industry in EU and US. 456 persons have been solicited through emails and phone calls, 107 have responded to the questionnaire. Respondents were mostly occupying senior positions in medical affairs, health economics and outcome research. Results: 27% RWS conducted are requested by Health Authorities, 73% on the industry initiative. 75 % of those studies are subcontracted to a CRO. The main criteria of choice are the experience in RWS, particularly in the regulation process, the capacity to deliver on time and a flexible and adaptable structure. The RWS activity is expected to increase by 25 % in the next two years. Most of those studies have safety and effectiveness objectives and to a lesser extent drug utilization and health economics and the most common therapeutic areas are: oncology, cardiovascular and metabolic disorders. In addition, pharmaceutical companies are conducting more and more epidemiological studies to prepare dossiers for market access (disease understanding, unmet needs, population targeting). Conclusion: The pharmaceutical market is becoming global and is expanding into new countries and therapeutic areas. The result is an increase in the need for RWS where the regulatory agencies are asking for additional data concerning the long term safety and effectiveness of the drugs when used on larger populations. Pharmaceutical companies face big challenges for the coming years especially in EU and there is an increase need for local regulatory knowledge. There's still need to increase awareness for the importance of real world studies and the impact it has on the patient's life.