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The staff and experts of the European Medicines Agency (EMA) publish articles on the Agency’s scientific activities in scientific publications, such as journals or textbooks. V., Watkins J., Daniel Mullins C., Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making, Pharmacoepidemiol Drug Saf. Access to the full text of the publications may be restricted to those who have an individual or institutional subscription.

A., Pyörälä S., Ružauskas M., Sanders P., Teale C., Threlfall E. [Epub ahead of print]Raimi-Abraham BT, de Orbe Izquierdo MS, Collignon O, Cerreta F, Regulatory considerations on the enrollment of older adults in oncology clinical trials, J Geriatr Oncol. doi: 10.1016/20, Epub 2017 Mar 9Salmonson T., Dogné J. 2018 Jan 15;16(1):6Tafuri G., Lucas I., Estevão S., Moseley J., d'Andon A., Bruehl H., Gajraj E., Garcia S., Hedberg N., Massari M., Molina A., Obach M., Osipenko L., Petavy F., Petschulies M., Pontes C., Russo P., Schiel A., Van de Casteele M., Zebedin-Brandl E. M., Rasi G., Vamvakas S., The impact of parallel regulatory-HTA scientific advice on clinical development. Aartsma-Rus A., Balabanov P., Binetti L., Haas M., Haberkamp M., Mitchell J., Mário M. P., Koenig F., Mavris M., Posch M., Regnstrom J., Vamvakas S., Vetter T., Marketing authorisation of orphan medicines in Europe from 2000 to 2013, Science Direct, October 2017Anton R., Haas M., Arlett P., Weise M., Balabanov P., Mazzaglia G., Prieto L., Keller-Stanislawski B., Raine J., Drug-induced progressive multifocal leukoencephalopathy in multiple sclerosis: European regulators' perspective, Clin Pharmacol Ther. doi: 10.1002/cpt.604Bahri P., Fogd J., Morales D., Kurz X., ADVANCE consortium, Application of real-time global media monitoring and ‘derived questions’ for enhancing communication by regulatory bodies: the case of human papillomavirus vaccines, BMC Med. The use of a 10% dilution classifies the baby and adult shampoos in two different categories of irritation.A benchmark approach can be applied using this concentration to evaluate the ocular irritative risk of adult and baby shampoos in developing countries.Assessing the uptake of regulatory and HTA recommendations, Br J Clin Pharmacol. R., Muntoni F., Finkel R., Mercuri E., Stakeholder collaboration for spinal muscular atrophy therapy development, The Lancet Neurology , Vol 16(4), p.

264Aartsma-Rus A., Straub V., Hemmings R., Haas M., Schlosser-Weber G., Stoyanova-Beninska V., Mercuri E., Muntoni F., Sepodes B., Vroom E., Balabanov P., Development of exon skipping therapies for Duchenne muscular dystrophy: a critical review and a perspective on the outstanding issues, Nucleic Acid Ther. J., Guðmundsson A., Haberkamp M., Jansen P., Marchionni N., Morgan S., Rönnemaa E., Petrovic M., Pilotto A., Rosa M., Wildiers H., Baseline frailty evaluation in drug development, J Frailty Aging., vol. M., Dunder K., Salmonson T., Mentzer D., Müller-Berghaus J., Hemmings R., Veselý R., Extrapolation in the development of paediatric medicines: examples from approvals for biological treatments for paediatric chronic immune-mediated inflammatory diseases, Arch Dis Child. Cerreta F., Ankri J., Bowen D., Cherubini A., Cruz Jentoft A. Z., Bate A., Bousquet C., Brueckner A., Candore G., Juhlin K., Marcia-Martinez M. R., Fermont I., Hagemann U., Hartigan-Go K., Hugman B., Mol P. A., Brewster M., Brown P., Cabral-Lilly D., Cruz C. M., Haubenreisser S., Jacobs A., Malinoski F., Morefield E., Nalubola R., Prud'homme R. M., Shahbazian H., Subbarao N., Tamarkin L., Tyner K., Uppoor R., Whittaker-Caulk M., Zamboni W., 'Summary report of PQRI workshop on nanomaterial in drug products: current experience and management of potential risks', The AAPS Journal, Vol. E., Rodriguez Mañas L., Mercier J., Bringer J., Camuzat T., Bourret R., Bedbrook A., Kowalski M. et al., Operational Definition of Active and Healthy Ageing (AHA): A Conceptual Framework, J Nutr Health Aging. doi: 10.1007/s12603-015-0589-6Butlen-Ducuing F., Zienowicz M., Pétavy F., Haas M., Salmonson T., Eichler H. H., Pelliccia A., Rasi G., Bonini S., Asthma, allergy and the Olympics: a 12-year survey in elite athletes, AIDA and the Italian Unit of the GA2LEN Olympic Study, Curr Opin Allergy Clin Immunol. doi: 10.1097/ACI.0000000000000149Bousquet J., Kuh D., Bewick M., Standberg T., Farrell J., Pengelly R., Joel M. Ehmann F., Papaluca M., Di Giuseppe F., Pani L., Eskova A., Manolis E., Herold R., 'Changes and determination of dosing recommendations for medicinal products recently authorised in the European Union', Expert Opin Pharmacother, Vol.16(6), pp. For more information on a particular publication, contact the corresponding author.