Join us as we track the latest legal and regulatory ramifications for biosimilar stakeholders. Be part of interactive discussions that will enable you to develop a wholistic legal and regulatory strategy for maximising commercial results for your biosimilar products.
Benefit from in-depth discussions which will allow you to:
- Comprehend how global affairs are transforming the development and commercialization of biologics and biosimilars
- Analyse the global legal and business ramifications of the EMA and FDA biosimilar regulatory pathways
- Understand the significance of regulatory exclusivities in biosimilar development from the perspectives of both originators and biosimilars
- Evaluate the impact of the current SPC landscape and the implementation of the UPC
- Traverse the complexities of U.S. market entry: naming, labeling, and marketing concerns
- Implement winning strategies to prevent compliance breaches of EU competition law
- Learn how AI and data mining accelerate drug discovery and development
Testimonials
Excellent content and very good speakers.
Interesting mix of interconnected topics related to biosimilars. Excellent speakers. Good networking opportunities. Very nice conference venue with excellent food.
I attend over a dozen conferences a year, and C5 events are among my favorite to attend. This one, in particular, was unique in that it connected a number of very important non-traditional topics that I think are critical to the area of biosimilars, not the least of which is bringing together the global perspective on the legal, regulatory, and economic challenges faced by biologics and biosimilars around the world and providing a forum for us all to discuss new ideas on how to address these global challenges. Keep up the terrific work!
About this Conference
Understanding the regulatory framework, the potential adaptation of competition law, and the impact of the Unified Patent Court will be essential to biosimilar manufacturers as they develop new strategies to overcome barriers to market entry. Additionally, they need to take stock of new complications in the patent landscape and include commercial considerations, to take advantage of growth opportunities.
Year after year, C5 brings together key stakeholders that are impacting the global biopharmaceutical legal and regulatory landscape. Attend and learn how IP and regulatory changes are impacting the business of biosimilars — not just in Europe — but across the globe. Our faculty of diverse thought leaders will provide practical advice and winning strategies for biopharmaceutical companies seeking to navigate this multifaceted legal and regulatory atmosphere and benefit from the amazing opportunities that this new landscape presents.
This event has been designed for representatives from corporate organisations from functions include:
IP FUNCTIONS:
- VP Intellectual property
- Managing Counsel – Patents
- Head of Biotechnology Unit
- Patent Attorney
- IP Director
- Chief IP Counsel
- Vice President, Global IP & Litigation
- Director of Biotech Intellectual Property
LEGAL & REGULATORY FUNCTIONS:
- Legal Director
- Biosimilar Business Integrated Program Management
- International Regulatory Strategy
- Global Policy & Market Access
- Portfolio Strategy and Operations
- Clinical Development – Biosimilars
LEGAL PRACTITIONERS SPECIALISE IN:
- Intellectual Property and Patent Law/ Litigation
- Life Sciences
- Biotechnology
- Biopharmaceuticals
- Competition
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