The Challenges in Clinical Project Management for Post- Authorization Safety Study on Emergency Use Authorization Covid-19 Medicine in Indonesia

Introduction: Post Authorization Safety Study (PASS) as part of the Pharmacovigilance method to monitor the safety of products, especially for medicinal products under Emergency Used Authorization (EUA) approval is challenging for the local Pharmaceutical Industry in Indonesia. Hence preparing and executing the study in a short period, during limitations in the Covid-19 pandemic situation, and meeting Good Clinical Practices (GCP) standards is quite a challenge. Objective/aim: To prepare and execute the PASS study for Favipiravir and Remdesivir as Covid-19 EUA medicines in Indonesia Methods: We conducted Sites identification, selection, and execution of the PASS study for Favipiriravir and Remdesivir in order to collect Cohort retrospective safety and efficacy data. It is needed to identify which sites have enough retrospective data, human resources, and willingness to collaborate and execute these studies. Since this was a mandatory study from the Indonesian FDA, hence the Study protocol and template of the Data Collection Form (DCF) were provided by them. Training for GCP and how to analyze the data was also provided by the Indonesian FDA to support any Pharmaceutical Industries that had not had this knowledge yet. All investigators needed to be trained to have a good understanding of study protocol, data selection and retrieval from the subject medical records, and transfer the data into an electronic Data Collection Form (e-DCF). Source Data Verification was done by the Study Monitoring team to ensure the correctness of data transferred to e-DCF. These studies were required to execute and finalize within 3 to 5 months. Results: Sites selection played a crucial part considering the peak of Covid-19 cases and limitations in human resources available to support this study at the sites. Some of the Sites candidates could not participate for that reason. Collaboration between the Pharmacovigilance team and Clinical Research team who have better competencies in GCP made the execution of these studies possible. Collaboration with external parties who provided e-CRF and training to investigators also played a significant role to expedite these studies. Good Clinical Project Management i.e. coordinating all parties made the execution of these studies meet the targeted timeframe. Conclusion: These projects provide a good exercise for managing the Clinical Project of Pharmacovigilance studies. To perform PASS effectively, each Pharmacovigilance team in Pharmaceut