• Sydney, 4 October 2017 Sydney Workshop
  • Melbourne, 5 October 2017 Melbourne Workshop
  • Brisbane, 10 October 2017 Brisbane Workshop
  • workshop

    Workshop Description:
    This workshop will cover technical and regulatory strategies for pre-clinical development of medicines – from small molecules and biologics to cell and gene therapies, from a global perspective. The sessions are designed to provide attendees with an in-depth understanding of pre-clinical development pathways and requirements leading to the most expeditious regulatory strategy. Potential pitfalls in the development and registration of drugs and biological medicinal products will be discussed in light of selected case studies, with details to provide practical advice as well as highlight key aspects underpinning success and failure. Learn how to design your pre-clinical studies from the experts!

    Elements being discussed include:
    Customised approaches to target your product and its intended use Optimisation of pre-clinical development How to leverage information from regulatory intelligence to maximise outcomes Navigation of regulatory challenges across jurisdictions Working smarter within the regulatory landscape, especially as a SME

    Workshop Outline:
  • Challenges in pre-clinical development, particularly for complex therapies
  • Pharmacology: PK/PD, safety, new developments, animal models and assays
  • Toxicology studies and their rational design
  • Technical advances in toxicological assessments
  • Case studies in the pre-clinical world (successes and failures)
  • AU, EU or US – do jurisdictions matter?
  • Can there be control of pre-clinical timelines?