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Blog Penny Field 2015-02-16T01:28:32+00:00

Recent Posts

  • Expedited Pathways
  • Updated TGA Guideline on the Regulation of Biosimilars
  • Proposed Changes to Immunogenicity Requirements for Biopharmaceuticals (Part 1)
  • CMC Development of Biosimilars
  • The Trans-Pacific Partnership and Biological Medicines

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    • Biologicals and Biopharmaceuticals
    • Biosimilars
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    • Expedited Pathways
      October 18th, 2016
    • What’s required to register a prescription medicine?
      August 28th, 2014
    • Does the benefit of the medicine outweigh the risk?
      August 29th, 2014
    • Expedited Pathways
      October 18th, 2016
    • Updated TGA Guideline on the Regulation of Biosimilars
      January 22nd, 2016
    • Proposed Changes to Immunogenicity Requirements for Biopharmaceuticals (Part 1)
      November 30th, 2015
    • CMC Development of Biosimilars
      November 26th, 2015
    • The Trans-Pacific Partnership and Biological Medicines
      October 7th, 2015
    • Traversing the valley of death: regulatory challenges in the transition from discovery to development
      September 15th, 2015
    • Approval of Infliximab Biosimilar in Australia
      August 24th, 2015
    • European Guidance with regard to Biosimilar Recombinant G-CSF
      July 29th, 2015
    • Safety of biosimilar medicines
      June 19th, 2015
    • Gene Therapies
      May 30th, 2015
    • The Challenges of Immunogenicity
      April 22nd, 2015
    • Regulatory Evaluation of Biosimilars
      March 24th, 2015
    • Shared Evaluation of Generic Applications
      February 10th, 2015
    • Global Development of Biosimilars
      January 27th, 2015
    • Adaptive Pathways for Drug Development
      December 23rd, 2014
    • Australia and New Zealand Therapeutics Product Agency (ANZTPA) – What Next?
      November 21st, 2014
    • Data exclusivity
      November 13th, 2014
    • Biotherapeutics Manufacturing
      October 21st, 2014
    • Tissue and Cell Therapies
      October 13th, 2014
    • Cell Banks: the Foundation of Biotechnology/Biological Products
      October 10th, 2014

    Recent Posts

    • Expedited Pathways
    • Updated TGA Guideline on the Regulation of Biosimilars
    • Proposed Changes to Immunogenicity Requirements for Biopharmaceuticals (Part 1)
    • CMC Development of Biosimilars
    • The Trans-Pacific Partnership and Biological Medicines

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