This meeting is focused to educate the officials to understand the importance of timely reporting of ADRs for better health and safety of the patients. Which also specifically involves sensitising them about their greater role of not only monitoring, but also proactively assessing and managing drug risk throughout a product’s lifecycle, from development to post-market.
Dr V Kalaiselvan principal scientific officer IPC informed that this interactive meeting will touch base on developing guidelines for the implementation of pharmacovigilance system for pharmaceutical industry. Most importantly, it will also focus on requirement for pharmacovigilance audit and inspections at marketing authorisation holders (MAHs), or companies with an approved clinical trial application (CTA).
He further assured full technical support to pharma companies for strengthening the pharmacovigilance system, with active training and educational support by PvPI. He stressed on the need to train the officials on the submission of ADRs data in E2B, xml format to NCC-PvPI to facilitate hassle free transport into VigiFlow along with training on the submission of updated patient information leaflets (PILs) by pharma companies to NCC-PvPI.
He pointed out that companies are required to collect, assess and report adverse events within the specified reporting time to avoid serious repercussions from any drug having a potentially serious side-effect profile, which can have enormous health implication on the patients. “We do understand that the safety of drugs is very important to ensure better healthcare environment in the country, to ensure this and actively help the industry in overcoming their challenges the IPC will be working to have more coordination between IPC, CDSCO and the stakeholders. By bringing the stakeholders completely under the fold of the PvPI, we definitely will be able to strengthen the programme further, which is crucial for better patient health,” he added.
Pharm.D @ SRIPMS-CBE-TN