Isha Verma

Regulatory Affairs Executive @Insignia Clinical Services

New Delhi, IN

Analyse the changes in the Acts, Rules, Regulation and provide comparative data with regards to changes from existing Acts, Rules, Regulation along with preliminary impact assessment•Monitor any circular, office order which is not uploaded on website but are displayed in the notice board of CDSCO and share relevant copies with the Company along with preliminary impact assessment.•Monitor changes in Indian Pharmacopoeia monographs or issuance of new monographs by Indian Pharmacopoeia Commission (IPC) and share those updates with the Company.•Assistance in submission of representation to IPC in relation to changes in the existing monographs or new draft monographs.•Closely working with Medical Affairs and other cross functionsl teams to liaise with SEC Members for creating a better understanding of SEC expectations on technical presentations for positive outcome during SEC meetings.•Maintain routine connect at HA level to avail advance access to business-critical.•Provide impact assessment and devise strategies to minimize impact and ensure business continuity and growth•Review of dossiers prior to submission for New Drugs Applications, Import and Registration, Post Approval changes, Clinical Trial Applications etc.•Track and monitor Subject Expert Committee (SEC) meeting minutes by Central Drugs Standard Control Organization (CDSCO)•Find out the cases of successful and failed local trials, waivers of drugs and vaccines along with reasons/factors for such failures or success•Track from Clinical Trial Registry (CTRI) clinical trials related data in terms of indications, number of patients, phases of the studies,•Monitor time gap between approval of innovator drugs in various countries example US/EU and its approval in India using the data available on Food and Drug Administration (FDA), European Medicines Agency (EMA), Central Drugs Standard Control Organization (CDSCO) and any other drug regulatory agency websites