The Department of Pharmaceutical Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, in collaboration with GlaxoSmithKline (GSK), Bengaluru organized online Regulatory Sessions for the faculty and postgraduate students on 2nd June 2023 where 8 resource persons spoke on various regulatory themes.
Dr. R Narayana Charyulu gave the opening remarks and welcomed the resource persons and the participants. Dr. CS Shastry, Principal, emphasized the need of industry and academic partnership and knowledge sharing for mutual benefit of both parties. The program facilitator, Ms. Smitha, Associate Director RIMS, GSK, described how the sessions were organized and invited active engagement from the attendees.
In the first session Ms. Chetana Thakur delivered a talk on “Regulatory Publishing - Overview” where she explained how new products are registered and stated that publishing is a link between the Regulatory department and Health authority. She mentioned the categories of regulatory publishing and also explained terms such as Metadata, DTD and MD5 checksum.
The next session was engaged by Ms. Ripal Patel on the topic “Marketing Authorization Procedures in USA & EU proposed by GSK”. She explained the four marketing authorization procedures of EU and discussed about the generic drug approvals in the US. Ms. Patel also talked about patents and drug exclusivity. This was followed by a lunch break.
The afternoon session began with a lecture by Mr. Srikant V, who spoke about Regulatory Information and Management Systems (RIMS). Mr. Srikant emphasized the importance of regulations and explained the RIMS framework and mentioned the significance of the ‘up-to-date’ data. The next session on “Drug Labeling Overview” was taken up by Mr. Kalp Jamalta. He mentioned that labeling is a scientific department under regulatory and explained about labeling, global serialization and core labeling. He also reiterated the labeling requirement of US and EU, and the consequences of errors in labeling.
Ms. Nikita Gaga engaged the next session on “Data Integrity issues in Pharmaceutical Industry”. Ms. Gaga emphasized that data must always be complete, accurate, and consistent and should never be falsified. She explained the ALCOA principles and ALCOA+ for maintaining data integrity. She presented case studies to facilitate understanding.
The final session for the day was by Ms. Likhita Shetty on “Changes in Regulatory Guidelines and intelligence database Environment - Current Updates”. She explained about major submission preparations and market specific requirements. She also talked about stringent regulatory guidelines like ICH, US FDA etc. and explained the Regulatory Intelligence process.
The program came to an end with a Question & Answer session. Dr. R. Narayana Charyulu, Vice Principal proposed the vote of thanks.
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