RWE (Real World Evidence) is heightening the need for local knowledge and once patients are involved language and culture become key elements of success in carrying out and communicating local research. Investigators, authors, study participants, regulators and other stakeholders including local company affiliate staff need to have their communication needs taken into account. In many countries there is ignorance of publication guidelines such as GPP3 at all levels from investigator to authors to industry staff. Authors in many countries are reluctant to acknowledge conflicts of interest and writing assistance. Local knowledge and tact are required to ensure that local actions are effective and meet the compliance standards set at global level.
The presentation seeks to increase awareness of the cultural and linguistic challenges facing global medical affairs departments by giving real practical examples of problems and solutions.
Hyatt Regency New Orleans
Lizandra Marcondes, William Dolben