Who should attend
About Biopharmaceutical Industry
The objective of biopharma basics training is to impart fundamental know-how about biopharma market, different classes and regulations. In fact, focus is on learning biopharmaceutical R&D, biopharma market dynamics, manufacturing and regulatory aspects. Moreover, this comprehensive training program provides detailed understanding of both innovator biotech and biosimilar (similar biologic) in a single course. This advanced certification course utilizes interactive online learning tools to provide real life practical exposure. Therefore, participants will have understanding about the biopharmaceutical (biotech and biosimilar) market. Above all, users will be understanding key terminologies which are used in biopharma industry.
- Course Code: RYD-021
- Title of the course: Competency Development Training in Basics of Biopharma
- Types of the course: Online self pace learning course. User can conveniently access the course at own convenient timing.
- Duration: 1 Week
- Course Certification: It will be provided on completion of the course.
- Eligibility: Graduation / 3rd or final year graduation in any discipline. Even the final year student can join the course.
Who should attend this course?
- Biopharmaceutical professionals seeking to improve their skills in the regulatory environment.
- Pharmaceutical professionals who wants comprehensive knowledge about the biopharrmaceutical industry.
- Those moving into regulatory affairs from other areas within a bio-pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others).
- Anyone wishing to update their knowledge on USFDA regulatory knowledge for biopharma and biosimilars Regulatory Affairs, Registration and Documentation assistants/officers/managers.
- Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
- You will also eligible to receive the course study modules, which you can download by login to your course page.
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About Biopharmaceutical Industry
The biopharmaceutical industry is a branch of the pharmaceutical industry that focuses on developing drugs and therapies using biological processes. Biopharmaceuticals are derived from living organisms such as cells, tissues, or microorganisms and are used to treat various diseases.
The industry has grown significantly in recent years due to the increasing demand for novel and effective treatments for complex diseases such as cancer, autoimmune disorders, and genetic disorders. Biopharmaceuticals have shown promising results in treating these diseases by targeting specific molecular pathways in the body.
The biopharmaceutical industry includes various players such as biotechnology companies, pharmaceutical companies, research organizations, and academic institutions. These organizations work together to discover, develop, and commercialize biopharmaceutical products.
But the development process for biopharmaceuticals is complex and time-consuming, requiring significant investments in research and development, clinical trials, and regulatory approvals. However, the potential benefits of these products make the industry an attractive area for investment and growth.
Overall, the biopharmaceutical industry plays a critical role in advancing medical science and improving patient outcomes by developing innovative therapies that address unmet medical needs.
Key Classes about Biopharmaceuticals
Biopharmaceuticals are a diverse group of products that can be classified into several categories based on their structure, mode of action, and therapeutic application. Here are some common classes of biopharmaceuticals:
Monoclonal antibodies (mAbs): These are proteins that are engineered to target specific antigens on the surface of cells and are used to treat various types of cancer, autoimmune disorders, and infectious diseases.
Recombinant proteins: These are proteins that are produced using recombinant DNA technology and are used to replace or supplement missing or defective proteins in the body. Examples include insulin for diabetes and erythropoietin for anemia.
These are biopharmaceuticals that stimulate the body’s immune system to produce an immune response against specific infectious agents. In fact, vaccines can prevent infectious diseases such as measles, mumps, rubella, and human papillomavirus (HPV).
These are products that aim to treat or cure genetic diseases by introducing a functional gene into the patient’s cells. Hence, gene therapies have shown promising results in treating rare genetic disorders such as spinal muscular atrophy and inherited retinal diseases.
These are products that use living cells as a therapeutic agent to treat various diseases. Examples include CAR-T cell therapy for cancer and stem cell therapy for spinal cord injuries.
These are biopharmaceuticals that are similar to an already approved biologic drug but are manufactured by a different company. Biosimilars can provide cost savings and increase access to treatment options for patients.
Overall, these different classes of biopharmaceuticals offer a wide range of therapeutic options for patients with various diseases, and ongoing research and development in this field of biopharmaceuticals. In fact it is leading to new and innovative treatments.
You must know:
- What is the major difference between biosimilar and interchangeable biological products?
- List of USFDA approved Biosimilar [till date]
- What is Biologic License Application (BLA)?
- USFDA Biosimilar Approval : 4 Biosimilar total and 3 new approval of biosimilar in 2016
- Significance of Purple Book
- 351(k) biologics license application