News from NGSMIPS | Webinar on Hand-holding: The way forward

The Dept. of Pharmaceutical Regulatory Affairs, NGSMIPS organized a 2-day webinar titled “Hand-holding: The way forward” on 6th & 7th January 2023. The webinar covered a variety of topics and provided an insight to the working world of a Pharma professional.

Prof. (Dr) R Narayana Charyulu, Vice Principal, NGSMIPS welcomed and introduced the resource persons who were alumni of the college and explained the objective of the webinar. Prof. (Dr) CS Shastry, Principal rendered the presidential remarks and highlighted the importance of such interactions for the benefit of students.

DAY 1

The first speaker, Mrs. Akshaya Bhandarkar, a freelance pharmaceutical trainer in Bengaluru, began the session by briefly discussing her career in the pharmaceutical industry. She described how she followed her passion for launching her own business. The upbeat independent trainer, content writer, pharma trainer and course developer walked her juniors through the various opportunities available in the enormous pharma world and how to utilise these openings wisely by building networks and taking short courses, which she believes is a great value addition to the juniors to start their careers. She explained the different career opportunities in Quality Assurance, different R&D paths and life cycle of Quality Management System (QMS) in an industry in her presentation and covered the possible roles & responsibilities of a junior associate in QMS. Akshaya Bhandarkar asserts that studies continue after M.Pharm.

The second session was conducted by Ms. Bhashini and Ms. Jean Sandra Pinto, Regulatory Analysts, Merk Life Sciences, Bengaluru, who explained the nuances of regulatory submission using Veeva Vault RIMS. Ms. Bhashini dealt with the topic, Regulatory from industrial perspective and explained core regulatory & operational regulatory. She described how regulatory submissions have been advancing over the last few years because of the development of different softwares like Veeva Vault RIMS and many more.

The afternoon session saw Ms. Kavya Shetty, Marketing Analyst in IQVIA, Bengaluru focusing on the concept of competitive intelligence. She elaborated on the process of gathering & analyzing information about the industry & business on a global level, for present & future perspectives.

The last session of day was delivered by Ms. Teena George, Regulatory Affairs Associate in Merk Specialities Pvt Ltd., Bengaluru. Teena explained in detail about Investigational Medicinal Product Dossier (IMPD) where she discussed about template management & formatting of documents. The day one sessions concluded successfully with a great flow of knowledge to the juniors by the speakers.

DAY 2

In the opening session, Ms. Akshatha G, Sr. Executive in Viatris, Bengaluru explained about Medical Device Regulations, how the medical devices sector works and its regulatory framework in the European Union. She motivated the juniors to consider the field of medical devices regulations for their career. The second session was carried out by Ms. Swathi Pai, Regulatory Affairs Executive at Micro Labs Limited, Bengaluru. She enlightened the juniors about BCS (Biopharmaceutics Classification System) based biowavers by explaining what is a biowaver, different criteria for biowaver, Class 1 & Class 3 significance, BCS classification & its importance for generic drugs.

The last session was conducted by Mr. Darewin Mendonsa, Regulatory Affairs Specialist in GSK, Bengaluru. With his unique way of inspiring the juniors, Darewin skipped the conventional method of using a power point presentation and rather chose to put forward his ideas through an interactive session where he shared his personal experiences in the pharma field and explained how even a small opportunity could be a window to a great success story.

The students not only gained knowledge about different topics covered by the speakers but also grasped the concept of “industry-ready attitude” which is highly required in a dynamic pharma world. Dr. Akhilesh Dubey, Asst. Professor delivered the vote of thanks & Dr. Manohar M, Asst. Professor from the Dept. of Pharmaceutics & Pharmaceutical Regulatory Affairs moderated the event.