MHRD Institution’s Innovation Council & Placement cell of University Institute of Pharmaceutical Sciences (UIPS), Panjab University, Chandigarh organized a webinar under UIPS Expert Talk Series on the topic “Administrative requirements for generic drug filing with Food and Drug Administration(FDA)” by Dr Bobby George, Vice President and Group Head, Regulatory Affairs, Reliance Life Sciences Pt. Ltd., Mumbai, today.
Professor Indu Pal Kaur, Chairperson & Head Placement Cell UIPS, extended a warm welcome to everyone and introduced the speaker, Dr Bobby George who is a proud alumnus of UIPS, Panjab University with an industrial experience of more than 23 years. He worked in Dabur Research Foundation, Sahibabad (5 years) in clinical research division for oncology drugs.
Dr George highlighted about the fundamental mission of the FDA, which is to protect the public health, by collecting information which is then used for important activities such as post-market surveillance, inspection of drug manufacturing and processing facilities, and monitoring of drug products imported into the U.S. He then touched upon few of the administrative requirements associated with generic drug filing including establishment registration; drug listing; NDC number, DUNS number, user fees; self-
identification; their submission timelines and implications for non-compliance.
He stressed upon the critical need of comprehensive, accurate, and up-to-date information required in conducting these activities with efficiency and effectiveness.
The talk was followed by an extensive Q&A session and was concluded successfully with a note of thanks by the Chairperson, Professor Indu Pal Kaur. Around 210 participants joined the webinar which included students, researchers, UIPS faculty and distinguished guests.