Biography
Biography: Abhay Chimankar
Abstract
With the ever-increasing requirement from various regulatory authorities across the globe, the marketing authorization holders (MAHs) are required to comply with these requirements. To meet the expectations from multiple regulators, it becomes difficult for MAHs to sustain the team, resources and also to manage the global team within the budget. One of the challenges is to have global compliance in terms of regulatory reporting, identification, assessing, reviewing the ICSRs and reporting them on-time. At the same time, the ICSRs are to be exchanged with the global partners. Right at the start and sustain the rightness through various processes including the risk based audits of various functions is the key to this compliance. Well trained and experienced resources and retention strategy play important role in the PhV system. Automation processes which are validated and compliant to the requirements help MAH to minimize the manual inputs wherever possible e.g., literature imports, identification of key index term, using auto mails for follow up communications, generating various reports like KPI dashboard and compliance reports. The safety databases to be used to its fullest capabilities, right IT partners (in-house or outsourced) helps in this to align.