Everyone involved in clinical research must follow Good Clinical Practice (GCP) as specified in ICH GCP and the international ISO standard 14155:2020,
Clinical investigations with medical devices should be performed by health care professionals with scientific and medical qualifications and
According to clinicaltrials.gov Europe is home to the second larges number of clinical trials. During the COVID-19 pandemic, the number of clinical
This article describes seven career paths available to people seeking to break into the field of clinical research. Clinical
Not all products sold in the European Union (EU) need to bear CE marking. CE marking is only mandatory for those products that fall under
AKRN is pleased to announce the partnership agreement with the European Pharmaceutical Law Group - Eupharlaw. Health Law embraces the regulatory
Excellent Team and Strong Operational Performance We ended 2020 with significant momentum, which is expected to continue in 2021 with a
In-vitro medical devices Regulation (IVDR) The in-vitro medical devices Regulation (IVDR) is the new harmonized regulatory framework to ensure
Good study practice for clinical evaluation of in-vitro diagnostic medical devices The International Standard for clinical performance studies
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