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SAFETY SPECIFICATIONS FOR BIOSIMILARS
Session Chair(s)
Marin Banovac
Scientific Officer, European Medicines Agency, Netherlands
With the increasing number of biosimilars entering the market, the PRAC highlighted the need to better streamline the safety specifications for biosimilars. This session will update all stakeholders involved in ongoing EMA and PRAC activities with regards to the safety specification for biosimilars.
Speaker(s)
EMA recommendations on streamlining safety specification for biologicals
Nuria Semis-Costa, MSc
Scientific Specialist (Risk Management), European Medicines Agency, Netherlands
Safety Concerns and Biosimilars: Challenges and Uncertainties
Phillip Eichorn
Senior Director in Worldwide Safety & Regulatory, Pfizer Ltd, United Kingdom
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