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Helen Critchley

Country Regulatory Head – Australia & NZ Sanofi

Helen has over 35 years’ experience in the pharmaceutical industry, initially in global R&D working in formulation development and manufacturing and subsequently Regulatory Affairs. Helen has broad experience in global drug development from startup biotech to large pharma organizations across a diverse product portfolio. She has worked in global and local roles covering EU & International countries and is currently based in Australia.

Helen is co-chair of the Medicines Australia Regulatory Affairs Working group and a member of the 5 trade association group for the ACCESS countries that published the results of the industry survey earlier this year.

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See Helen Critchley at this event

  • Day 1 Tuesday 3 December

Access Consortium

09:00 - 10:30 CET / 19:00 - 20:30 AEDT

Session objectives:

  • Share high-level overview of Facilitated Product Introduction & TGA’s Regulatory Strengthening Program
  • Provide platform for greater understanding of ACCESS Consortium (how it works, future plans, industry experience, etc.)

Speakers

  • Day 3 Thursday 5 December

E-labelling as a pathway to a future Universal Label

07:30 - 09:00 CET / 17:30 - 19:00 AEDT

Session objectives:

  • Share the experience of adopting e-labelling, and opportunities for further harmonization and better interoperability.
  • Open a dialogue on the concept of universal labelling, in the context of an evolving digital healthcare ecosystem highlighting its potential to streamline supply chain logistics, reduce packaging waste, and support a green economy.
  • Examine how these systems may alleviate drug shortages, enhance preparedness for future pandemics, and expedite manufacturing processes.
  • By initiating this vital conversation now, the session seeks to align direction around future digital labelling options.

Speakers