C5 is pleased to present its inaugural Global Legal and Regulatory Summit on Biosimilars. This exclusive European event has been specifically designed for In House IP Counsel and Directors, Strategists and Business Development Executives, as well as Regulatory Affairs Executives and attorneys operating within the biosimilars community.


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Day 1  |  3rd December 2019

9:00 Co-Chair Opening Introduction
9:10 Anticipating the Potential Brexit Effect on the European Biosimilars Marketplace
9:50 The International Perspective: Analysing the Present State of Global Affairs for Biosimilars
10:50 Networking Morning Coffee Break
11:20 Biosimilars Regulation in Europe and the U.S.: Comparing and Contrasting the EMA and FDA Approval Processes
12:00 Networking Lunch
13:00 Understanding How Regulatory Exclusivities Impact Innovator and Biosimilar Developers Part 1: Survey of Available Exclusivities Part 2: Panel Debate: Innovator vs. Biosimilar
14:30 Networking Break
15:00 Analysing the Practical Outcome of the Biosimilar Tendering Process
15:40 Town Hall on the Maximisation of IP Regulatory Rights
16:20 Spotlight: Biosimilar Litigation in the U.S.: A Multi-Disciplinary Perspective
16:35 End of Day 1
 

Day 2  |  4th December 2019

9:00 Co-Chair Opening Remarks
9:10 Competition and Compliance: A Guide for Innovators and Biosimilar Manufacturers to Avoid Anticompetitive Behaviours
9:50 Analysing Current SPC Landscape and The Effects of the Manufacturing Waiver on Biosimilar Drugs
10:50 Networking Break
11:20 Assessing Recent Israeli Patents Office Decisions for Biopharmaceutical SPCs
12:00 Biosimilar Patent Litigation: Major Considerations for Success in Europe and the U.S.
13:00 Networking Lunch
14:00 Biosimilars in Korea: Identifying the Most Recent Hurdles and Challenges when Launching a Biosimilar Drug in the Korean Market
14:40 Biosimilar Patent Litigation: Major Considerations for Success in Europe and the U.S.
15:20 Networking Break
15:40 Strategic Business Decision Making: Biosimilar vs. Biobetter
16:20 Conference Concludes