Biocon Academy introduces 16-week certificate program in Global Regulatory Affairs
Bengaluru: Biocon Academy, a CSR initiative of Biocon, and a Center of Excellence for Advanced Learning in Biosciences has introduced a new and unique program in Global Regulatory Affairs (GRA) in collaboration with JSS Academy of Higher Education and Research (JSS AHER), Mysuru.
The exclusive program is designed to impart applied knowledge on various good regulatory practices, clinical development processes, documentation and submission of filings, regulations for drugs, biologics and medical devices and legislation in regulated and emerging markets through an intensive curriculum.
Biocon JSSAHER Certificate Program in Global Regulatory Affairs is a one-of-its-kind 16-week program for students of pharmacy and other allied sciences in India, offering domain specific skills taught by the renowned faculty from JSS AHER having experience of offering this content for the past 20 years at the postgraduate level and by Subject Matter Experts from Biocon Group of Companies.
During the program, students will undergo experiential learning at regulatory departments of Biocon and Biocon Biologics, case studies conducted by Subject Matter Experts, and hands-on training in making e-CTD, eSUGAM filings and 356h submission. Students will also get an opportunity to visit JSS Hospital to understand clinical trial proceedings. Lastly, they will be provided training in professional writing and speaking skills to augment their success in the regulatory space.
Commenting on the program, Bindu Ajit, Program Dean of Biocon Academy said, "A regulatory affairs (RA) professional is expected to have a broad understanding of various aspects including drug discovery & clinical research, patent and legal strategies, etc. besides having sound knowledge of global and country specific regulatory requirements. Often, it becomes difficult for any bioscience and life science graduate to match with the industry expectations. With this new course of Biocon Academy through our partnership with JSS, we are aiming to deliver the best-in-class curriculum to the students and also offer them complete practical exposure in various disciplines, much before they are recruited by any pharma and biopharma company. This course will equip them with the relevant industry skills required to be successful in their career as a RA professional."
She also added, "We are delighted to partner with JSS AHER to bring this unique program to students of pharmacy and other allied sciences. To ensure holistic approach, the students will get an opportunity to have hands-on training with PharmaReady- NJ, Glova- Blr, CDSCO-New Delhi, JSS Hospital-Mysuru, and will also benefit from Employee Shadowing during the 16 weeks of extensive learning program. Considering that, we are offering this course at a very affordable price due to the scholarship of 60% of the program cost provided by Biocon Group of Companies, makes this a perfect pathway for the students to build a robust career in regulatory affairs."
Dr T M Pramod Kumar, Dean, Faculty of Pharmacy, JSS AHER said, "Biocon Academy is doing an exceptional job in bridging the gap between academia and the industry in association with several prestigious academic institutes. JSS has been imparting knowledge to pharma students for more than 3 decades at postgraduate level, and we are privileged to be the knowledge partners for the Biocon JSS AHER Certificate Program in Global Regulatory Affairs. We are looking forward to a fruitful collaboration with the Academy in the preparation of student's industry readiness and on their further career prospects."
The admissions are open now till 1st August 2021, and the course will commence from 30th August 2021, at Bengaluru. To enrol and kickstart your career as a Regulatory Affairs professional, visit https://www.bioconacademy.com/program_overview_gra.aspx
More details about the program:
• Program Name: Biocon JSS AHER Certificate Program in Global Regulatory Affairs
• Eligibility: B Pharm / M Pharm / M Sc (Biotechnology, Microbiology, Biochemistry, Allied Science) with CGPA of 6.8 or at least 65%
• Scholarship: 60% of the program cost by Biocon to all selected students
• Students Share of the Program Fee: Rs 75,000 + GST
• Duration of the program: 16 weeks
• Curriculum: Preparatory Regulatory Affairs, Small Molecule Regulatory Affairs (Drugs), Large Molecule Regulatory Affairs (Biologics), Clinical Regulatory Affairs, Medical Devices Regulatory Affairs, and Documentation and Regulatory Approvals.
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