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Accelerating CMC Workshop

Innovation and Convergence in a post COVID-19 world


Session 3: The (Digital) Future of CMC Submissions

Session Chair(s)

Ursula  Busse, PhD, MBA

Ursula Busse, PhD, MBA

  • Head of Regulatory Intelligence & Policy
  • Boehringer Ingelheim, Germany
Alastair  Nixon

Alastair Nixon

  • Director, Submission Publishing
  • GSK, United Kingdom
Session 3: The (Digital) Future of CMC Submissions

Speaker(s)

Alastair  Nixon

CMC submissions – Past, Present and Future

Alastair Nixon

  • Director, Submission Publishing
  • GSK, United Kingdom
Norman Robert Schmuff, PhD

Structured product quality submissions - PQ CMC

Norman Robert Schmuff, PhD

  • Associate Director for Science, OPMA, OPQ
  • FDA, United States
Rodrigo  Palacios, MBA

Dynamic Regulatory Assessment - A Paradigm Shift for Industry and Regulators

Rodrigo Palacios, MBA

  • Regulatory Policy Lead
  • F. Hoffmann-La Roche, Switzerland
Mike  Abernathy

Leveraging Technology Through ACCUMULUS to Streamline CMC Filing and Review Activities

Mike Abernathy

  • Executive Director, Global Regulatory Affairs
  • Amgen, United States
Dmitriy  Rozdestvensky, MD, PhD

Panel discussion and Q&A, with the additional participation of:

Dmitriy Rozdestvensky, MD, PhD

  • Head, Division for Coordination of Common Market for Drugs and Medical Devices F
  • Eurasian Economic Commission, Russian Federation