Sam Salek's research while affiliated with University of Hertfordshire and other places

Publications (3)

Article
Background Amidst the growing number of patient-reported outcome (PRO) measures of fatigue being used in multiple sclerosis (MS) clinical trials and clinics, evidence-based consensus on the most appropriate and generalizable measures across different settings would be beneficial for clinical research and patient care. The objective of this research...
Article
Full-text available
Introduction The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate and conduct joint reviews of applications. One such collaborative medicines registration initiative is the Southern African D...
Article
Full-text available
Introduction ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall median time to recommendation of 12 months. All 16 SADC countries participate in the initiative as either active or non-active member...

Citations

... The results of this study show that applicants perceive that there has been a high degree of success and benefit from the ZaZiBoNa initiative for applicants, patients and regulators. A similar study was conducted with regulators (15) and the responses compared. Regulators and industry commonly agreed that information sharing among regulators and harmonisation of registration requirements across the region were the top benefits of the ZaZiBoNa initiative. ...