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Advancing Biosimilar Clinical Development The Neatherlands

Advancing Biosimilar Clinical Development The Neatherlands<br>OVERVIEW<br>Learn how to mitigate various risks in designing and executing biosimilar studies and how to avoid delays and maximise regulatory success with biosimilar development.<br>KEY TOPICS<br>In this Masterclass participants will Introduction to biosimilar pathways in EU and US: experiences so far and much more. <br>VENUE<br>Amsterdam, The Netherlands <br>http://bit.ly/2Z96IX9

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Advancing Biosimilar Clinical Development The Neatherlands

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  1. AURELIUS GLOBAL MASTERCLASS LEARN FROM THE BEST IN THE WORLD

  2. WHO ARE WE ? We find ourselves as problem solvers of the industry, technology and businesses for industrial organizations of all types and domains. We cover a wide array of industrial domains including Pharmaceutical development, Automotive, Transport, Oil and Gas extraction, Telecom, Business management, Manufacturing, Defense, Supply Chain Management and so on. Our key USP lies in the level 3 and above customized nature of our services suited to client’s needs. We measure our service’s success in tangible outputs and returns.

  3. WHAT DO WE DO ? We, the pioneers in the industry, owing to our reach are able to influence the best minds to help you improve your process specifications. We have been associated with the who’s who of the industry and have played our part in improving the process excellence of our customer partners. We have helped them improve their system methodology by trying to inculcate the best industry practices by providing deep insight and practicality in processes and in turn help them improve their process systems at large.

  4. Advancing Biosimilar Clinical Development Most up-to-date updates in regulatory and clinical areas around biosimilar developments. How to mitigate various risks in designing and executing biosimilar studies How to avoid delays and maximise regulatory success with biosimilar development Understanding around tailored clinical development

  5. KEY TOPICS • In this Biosimilars Clinical Development Masterclass participants will Introduction to biosimilar pathways in EU and US: experiences so far • In this Biosimilars Clinical Development Masterclass participants will Totality of the evidence and role of analytical data • In this Biosimilars Clinical Development Masterclass participants will Assessment of PK, PD, Immunogencity and safety in biosimilar studies • In this Biosimilars Clinical Development Masterclass participants will Tailored clinical development path • In this Masterclass participants will Most recent updated EMA and FDA requirement

  6. DATE & TIME • Start Time • 9:00 am • November 18, 2019 • Finish Time • 5:00 pm • November 19, 2019 • Address • Amsterdam, The Netherlands

  7. CONTACT US Email: masterclass.registrations@aureli us.in Phone: +44 2032 398083 OUR PAGE http://bit.ly/2Z96IX9

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