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A Practical Guide to Biosimilar Development StrategiesPTI
The biosimilar market is increasingly gaining prominence due to the loss of big-branded patent exclusivity and for their potential to reduce the cost of life changing medicines; making healthcare more accessible to the patient population.
However, biosimilars are difficult to verify 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.
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
- Product Development
- Business Development
- Project Managers
Training Course Content
- Develop your understanding of what biosimilars are and how they are defined by Regulators
- Understand the challenges of biosimilar development through a series of case studies
- Navigate through the complex regulatory landscape for biosimilars and familiarise yourself with the most recent developments
- Learn how to effectively position your biosimilar on the market to gain quick market access
- Gain first-hand insight into the latest trends within the biosimilar market
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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