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EMA did not make the documents public but shared them with representatives of patients, consumers, health care professionals, the pharmaceutical industry, academia, and medical journals a part of "targeted discussions" to finalize the draft policy.
They were of the following types: research articles published on biomedical journals (28%), interviewed expert opinion leaders (professors, researchers, head physicians, representatives of patients' associations or, less frequently, experts of companies) (59%), congresses (29%) or books (3%).
Conversely, if the source of information was of another kind (e.g., congresses or representatives of patients' associations), it was not possible to find out undisclosed financial conflicts of interest.
Legal representatives of patients signed informed consent prior to enrolment.
Representatives of patients were not in actual need of psychosocial care.
These stakeholders were representatives of patients, primary care professionals, health policy makers and inspectorate, health insurers, educational institutes and research.
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The remainder were other medical doctors, nurses, psychologists, physiotherapists, headache patients or representatives of patient organizations.
It was attended by approximately 100 researchers and clinicians, as well as several patients and representatives of patient support groups.
Patients in this new role do not participate as patient advocates or representatives of patient organisations.
Also, despite exceptional recruitment efforts, only two representatives of patient groups volunteered to take part in the study.
The focus groups were attended by physicians who developed and managed the databases, staff members of CVZ, representatives of health insurers and representatives of patient organizations.
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CEO of Professional Science Editing for Scientists @ prosciediting.com