Pharmaceutical Regulatory Affairs: Open Access

Joint Event on 6^th International Conference and Exhibition on GMP, GCP & Quality Control & 7^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR

September 25-26, 2017 Chicago, USA

Keynote

• Government and industry response to the US opioid epidemic

  Robert P Bianchi

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• Conducting effective FDA pre-sub meetings: Tell don’t ask… lead don’t follow!

  Michael Drues

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• Six essential do’s and don’ts for an effective GMP extractable and leachables strategy

  Shane P Smith

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• Strategic trends, current and future competitive landscape in biologics and biosimilars (follow-on biologics) drug development in USA and emerging markets-a brief snapshot from 2012 through 2022

  Yavuz S Silay

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• Global regulatory challenges and implications

  Eliana Silva de Moraes

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• Convergence of regulatory affairs and reimbursement/market access

  Stephen F Amato

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