Biocon JSS AHER Certificate Program in Global Regulatory Affairs
Program Highlights
This 16-week program is designed to impart fundamental knowledge on various good regulatory practices, clinical development process, documentation and submission, regulations for drugs, biologics and medical devices and legislation in regulated and emerging markets, through an intensive curriculum delivered by the renowned faculty from JSS AHER, Mysore and Subject Matter Experts from Biocon Group.
Career Opportunities
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. With this new course, students are offered complete practical exposure in various disciplines, much before they are recruited by any pharma and biopharma company.
Customised Curriculum
During the program, students will undergo experiential learning with Biocon Regulatory Science department, case studies will be 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 regulatory space.
Key Differentiators
- One-of-its-kind 16-week program for pharmacy students in India
- Experienced faculty from Biocon and JSS AHER
- Hands-on training including PharmaReady- NJ, Glova- Blr, CDSCO-New Delhi, JSS Hospital-Mysuru, Employee Shadowing, Pharmacovigilance Report 356h, and e-SUGAM
- Expert guidance and mentorship
- Job-ready skills with 100% guaranteed interview opportunities
Course Modules
Introductory/ Preparatory Regulatory Affairs
- Introduction to Regulatory Affairs
- Overview of Pharmaceutical markets and regulations
- GMP and GLP
- Intellectual Property and Intellectual Property Rights
Small Molecule Regulatory Affairs (Drugs)
- Regulated Markets like USA, European Union, and Japan
- ROW Markers like India, ASPAC (China, South Korea, Malaysia, Singapore), LATAM (Mexico, Columbia, Brazil), and Emerging markets like Africa (Tanzania and South Africa) and Middle East (any 2 countries)
Large Molecule Regulatory Affairs (Biologics)
Clinical Regulatory Affairs
- Clinical Drug Development Process
- Clinical Research Related Guidelines
- ICH Guidelines
- US-FDA Guidance
Medical Devices Regulatory Affairs
- Basics like introduction, product lifecycle of medical devices, risk-based classification, and essential principles of medical devices and IVDs, and differences between medical devices, IVDs and Combination Products from pharmaceuticals
- IMDRF/GHTF
- USA
- European Union
- Ethics
- Quality
Documentation and Regulatory Approvals
- Documentation in pharmaceutical industry
- Dossier and submission
- Audits
- Inspections
- Product lifecycle management
- Emerging Technologies
Eligibility Criteria
Program Fee & Scholarship
The Biocon Merit Scholarship of 60%-75% of the program cost offered to all selected students will enable them to pursue this one-of-its-kind program at an affordable cost.
Student Share: INR 1,00,000 + 18% GST
Student Facilities
At Biocon Academy, the students have to go through a rigorous curriculum so that by the time their course comes to an end, they are industry-ready and sought after by multiple companies. We encourage them to remain focussed and excel in everything they do. For the benefit of the students, we assist them with a couple of facilities to ensure they just focus on the curriculum.
Industry Placements
At Biocon Academy, we provide 100% interview opportunities to all our students. Ever since inception, Biocon Academy has witnessed 100% placement record in all the courses and batches with students being selected for leading pharma and biopharma companies and startups.
Transport
We understand that commuting to different locations for industry training can get challenging especially when students have to arrange for it themselves. Therefore, students are provided with group transport facilities from Biocon Academy to different training locations and then back to the Academy.
Accommodation
Students come to pursue studies at Biocon Academy from different parts of the country and upon their request, we provide options of nearby paying guests and hostel accommodations based on the previous student choices. Kindly note that students and their parents/guardians alone are responsible for any decision taken regarding their stay.