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Advancing Biosimilars Clinical Development

  • 14/03/2019 - 15/03/2019
  • Basel, Switzerland

Meet your expert in Global Drug Development and Clinical Research

  • Dr Alex Kudrin, MD, MBA, PhD
  • Biopharmaceutical Consultant
  • United Kingdom
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Key topics in Clinical Trials

Introduction to biosimilar pathways in EU and US: experiences so far

Most recent updated EMA and FDA requirements

Totality of the evidence and role of analytical data

Design of comparative clinical studies: how to mitigate regulatory risks and not impose the burden on development cost

Assessment of PK, PD, Immunogencity and safety in biosimilar studies

Pharmacovigilance activities and risk management plan

Tailored clinical development path

Introduction to biosimilar pathways in EU and US: experiences so far

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Key takeaways

Participants will learn to:

EMA and FDA expectations for biosimilar clinical studies

What factors should be considered in design of the study

Working with analytics: understanding impact of residual uncertainties and differences

Selection of patient population

Study specific considerations for assessment of safety and immunogenicity

Interchangeability and where switching data will be required

Training features

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 studies

Understanding around tailored clinical development

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from 2196 € Buy

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Based on your requirements, we will build a practical training including content tailored to your specific needs, our cutting edge methodologies and relevant modules from our training portfolio.

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JOIN US IN Basel

Basel is a city in northwestern Switzerland on the river Rhine. Located where the Swiss, French and German borders meet, Basel also has suburbs in France and Germany.  The city of Basel, located in the heart of the tri-border region is one of the most dynamic economic regions of Switzerland. 

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