Course description
A Beginner's Guide to Biosimilar Development Strategies
The biosimilar market is increasingly gaining prominence due to the loss of big-branded patent exclusivity and their potential to reduce the cost of life changing medicines and make healthcare more accessible to the patient population.
Biosimilars are difficult to verify though and are governed by stringent regulatory structures which are continuously evolving. This combined with the complex manufacturing process hinders the development of biosimilars, making it more important than ever to ensure you are compliant with the current regulatory procedures to benefit from this rapidly growing market.
This course will provide you with a comprehensive insight into biosimilar manufacturing so that you are equipped with a baseline understanding of what biosimilars are. Accompanied by a detailed oversight of the biosimilar market, you will analyse regulatory challenges and procedures, current trends and future predictions.
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Suitability - Who should attend?
This course would benefit professionals new to biosimilar development, or those who need an updated understanding of the regulatory landscape. Personnel in the following areas will find this course particularly useful:
- Regulatory affairs and compliance
- R&D
- Quality
- Manufacturing
- Product development
- Business development
- Project managers
Outcome / Qualification etc.
- Develop your understanding of what biosimilars are and how they are defined by Regulators
- Learn how to effectively position your biosimilar on the market to gain quick market access
- Understand the challenges of biosimilar development through a series of case studies
- Gain an insight into the latest trends affecting the biosimilar market
- Navigate through the complex regulatory landscape for biosimilars and familiarise yourself with the most recent developments
Training Course Content
- Module 1: Biological Medications Overview
- Module 2: What is a biosimilar?
- Module 3: The regulatory and IP landscape
- Module 4: Market access and performance
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5