3 Day Masterclass in Biosimilars 2018

This course extrapolates from conventional generics into the specialised area of biosimilars. By combining aspects of technology, regulatory affairs and commercial aspects, this course will provide yo... The 3 Day Masterclass Biosimilars is designed for senior management, directors, managers, supervisors, project planners and professional staff seeking to develop or implement a regulatory strategy for entering into biosimilars, including Project Managers, Regulatory Affairs, Manufacturing and Quality personnel. In Just 3 Days, you will: • Understand the difference between biologic drugs and small molecules. • Look at some of the manufacturing constraints in terms of Biosimilar processing. • See how these constraint affect regulatory approval processes and market impact. • Review the main Bisimilar approvals and the companies working in the Biosimilar space • Get insights into the areas of dispute including nomenclature, substitution, interchangeability and extrapolation. • Discover how these areas can have a dramatic effect on market models. • Consider the life cycle defence mechanisms of the innovator biologics including scientific approaches and legal and intellectual property issues. Time: 9:00 am - 5:00 pm. Category: Classes / Courses | Professional Training. Sub-Categories: Classes / Courses | Professional Training | Science, Health & Medicine. Artist/Speaker: Malcolm Ross. Brochure: https://go.evvnt.com/166157-0 Price: Standard - GBP 3000.