Biologic Regulatory Affairs online course provides training on biotech and biosimilar drugs development process and regulation. The course is designed to challenge users to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
Course Code: KPE-C-22
Course Title: KPE’s Certificate Program in Biologic (Biotech & Biosimilar) Regulation & Strategic Management
Course Objective: Working Professionals & B.Pharm/D.Pharm/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in biopharmaceutical marketing, business development and regulatory affairs, can pursue the course.
Nature of the Course: Distance & e-Learning
The course can be completed at any pace, allowing the user to stop and start at their leisure.
Features of the Course:
1. Comprehensive study material covering all important aspects of Biosimilar regulation.
2. Understanding/ Decision Making/ Strategy Creation in the field of Biosimilar regulation.
3. Live Pharma Case Study – File for easy understanding in biologics-biosimilar regulations and its implications.
4. Specialized modules on demand
5. Certificate will be issued at the end of the course.
Course Content Deliverables:
1. Printable Module can be downloaded by visiting to your dashboard.
2. Access the E-Modules online with user id and password.
3. Attend e-lectures.
4. Access to case study file online
5. All e-study material contains self assessment computer based test.
6. Flexible online final examination.
|Module 1||Drug Discovery and Development Process|
|Module 2||Biopharmaceutical – Detailed Understanding|
|Module 4||Biosimilar Development Process|
|Module 5||Biopharmaceutical Industry|
|Module 6||EU Biosimilar guidelines|
|Module 7||Biosimilar guidelines in different regions|
|Module 8||Licensing and Technology Transfer in Biopharmaceutical Industry|
|Module 9||Biopharma Case Studies|
Other than books, you will also get the online modules – electures, case studies etc. which you can access by login with your access credentials.
Biologic & Biosimilar Regulation and Registration course is structured as follows:
- Biotech Drug Development Process
Overview of the development of a biotech product – clarify the difference between synthetic drugs, biologics and biotech products .
- Biotech Regulation – Key Understanding
US drugs vs. Biologics Law: Understand the differences in regulatory philosophy between small molecules and biotech product regulation
- Preclinical and Clinical Research Design
An examination of preclinical and clinical research designs. Emphasis is on identifying and addressing challenges associated with elements of good laboratory and clinical practice and qualifying and managing a laboratory for a clinical trial. Discussion covers best practices for planning research and collecting, analyzing, and reporting data from drug/device development studies.
- Analytical techniques for the Biotech Drugs
Understand the need for using a range of analytical methods in the characterization of biotech product.
- Product Life Cycle Approval, Production, and Marketing for Bio-pharmaceuticals
An in-depth study of the product life cycle for biopharmaceuticals. Focus is on the various stages within the life cycle from conceptualization of a product pipeline in research and development through postmarket surveillance and production. Topics include regulatory submission, approval, production, and the postmarket environment for both drugs and devices. Challenges surrounding the approval and naming of follow-on biologics are addressed. Discussion also covers combination medicines, the stages of a drug pipeline and risk assessment at each stage, and the decreasing productivity of the drug pipeline. The role of a contract research organization in testing and approval is explained, and the nature of the support services they provide to the biotechnology and devices industry is explored.
- Global Biotechnology Business
Topics include international biotechnology issues, global harmonization efforts, and the cultural impact of biotechnologies. Discussion also covers domestic and International business considerations and international regulatory requirements.
Practical Case Studies – Applications of Biotech Regulatory Affairs
A capstone study of regulatory affairs related to the biotechnology industry that integrates knowledge and skills gained from previous study.
- Introduction to Global biopharmaceutical Industry. Overview of General Regulation.
- Biotech Drug Discovery and Development Process
- Biotech Drugs Classification. Important classes.
- Introduction to Biotech Industry – Global and Indian. Leading Biotech companies and their product and pipeline analysis
- Regulation in Biotech Industry
- Overview of patent in biotech industry.
- Introduction to Biosimilar. Meaning of Biosimilar vs. Follow on biologics.
- Difference between biosimilar and generic drugs.
- Key important issues in Biotech and biosimilar product manufacturing.
- GMP requirements in biotech industry.
- General approval process of biosimilar products.
- Biosimilar Development project management – timeline creation with business outcome
Country specific regulation in Biosimilar Products –
- Biotech and Biosimilar regulation in US
- Biotech and Biosimilar regulation in EU
- Major differences in US and EU
- Biosimilar regulation and registration in India
- Biosimilar policies in the UK, Use of biosimilars in Europe, EMEA regulation on biosimilar
- Registration of biosimilar in other different countries