CERTIFICATE COURSE ON BIOLOGICS & BIOSIMILARS
Organizers |
Faculty of Science |
Participants |
70 |
Contact No. |
|
Start Date |
19/02/2024 10:00 AM |
End Date |
08/03/2024 04:00 PM |
Venue |
MUIS |
Social Media Share |
Description
1. Introduction
The Certificate Course on Biologics and Biosimilar is designed to provide comprehensive knowledge and understanding of biologic drugs and their biosimilar counterparts. This report outlines the course objectives, content, structure, and outcomes.
2. Course Objectives
- Understand Biologics: Gain in-depth knowledge of biologics, including their development, production, and therapeutic applications.
- Explore Biosimilar: Learn about biosimilars, their regulatory pathways, and the differences from originator biologics.
- Evaluate Quality and Safety: Examine the quality, safety, and efficacy considerations for both biologics and biosimilars.
- Understand Market Trends: Analyze current market trends, challenges, and future directions in the field of biologics and biosimilars.
3. Course Objectives
- The Certificate course on Biologics & Biosimilar was Organized by the Department of Biotechnology & Microbiology, Mehsana Urban Institute of Sciences, Ganpat University.
- Coordinators: Dr. Vishal Patel & Dr. Ritesh Arya
- Date: 19th February 2024 to 8th March 2024
- Mode of teaching: Online (Zoom Platform) Total Hours: 30 Hours
- Time: 6:30 pm to 8:30 pm
- Fees: For GUNI students 1000/- Other participants: 1500/-
- Total Registration: 70
3. Course Content
Module 1: Introduction to Biologics
- Definition and Classification
- Types of Biologics (Monoclonal Antibodies, Vaccines, etc.)
- Mechanism of Action
- Historical Development and Milestones
Module 2: Biologics Development
- Drug Discovery and Development Process
- Clinical Trials for Biologics
- Regulatory Considerations (FDA, EMA guidelines)
- Manufacturing Processes and Challenges
Module 3: Biosimilars
- Definition and Classification
- Regulatory Pathways for Biosimilars
- Comparison with Originator Biologics
- Clinical and Immunogenicity Studies
Module 4: Quality Control and Assurance
- Analytical Techniques for Biologics and Biosimilars
- Quality Control Processes
- Stability and Storage
- Risk Management
Module 5: Market Dynamics
- Market Overview and Key Players
- Cost and Economic Impact
- Patent and Intellectual Property Issues
- Future Trends and Innovations
Module 6: Case Studies and Practical Applications
- Case Studies of Successful Biologics and Biosimilars
- Real-World Challenges and Solutions
- Industry Expert Insights
4. Learning Outcomes
By the end of the course, participants will:
- Have a solid understanding of the science and technology behind biologics and biosimilars.
- Be familiar with regulatory requirements and quality control measures.
- Be able to critically analyze market trends and economic factors affecting the industry.
- Apply knowledge to real-world scenarios through case studies.
5. Experts
- Munich Buch
- Dr. Prashant Kumar
- Dr. Vishal Patel
- Dr. Ritesh Arya
- Mr. Kinchit Shah
- Dr. Sweta Sanguri
- Dr. Priya Saroj
- Mr.Mithun Bhatt
- Dr. Bhushan Kulkarni
- Mrs. Sonali Panchal
- Ms. Ushma Joshi
6. Feedback and Evaluation
- Participant Feedback: Positive feedback on the comprehensive nature of the course and the expertise of instructors.
- Areas for Improvement: Suggestions for more interactive sessions and real-time industry insights.
7. Conclusion
The Certificate Course on Biologics and Biosimilars provides valuable insights into the rapidly evolving field of biologics and biosimilars. It equips participants with the knowledge and skills necessary to navigate the complexities of drug development, regulatory requirements, and market dynamics.