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Going Global Module 6 – Europe – Workshop: Navigating cell and gene therapies through global regulatory pathways

August 14 @ 9:00 am - 5:00 pm AEST

This workshop is the core component of the sixth and final module in the Going Global program. It will provide a deep dive into the commercial development of cell and gene therapies through global regulatory pathways.

 


About the workshop

The workshop will provide a deep-dive into the commercial development of cell & gene therapies through global regulatory pathways. In particular, it will highlight commonalities and differences in major regulatory requirements in key markets and provide guidance on how to accommodate or incorporate these to build a more efficient global development program.

ERA Consulting Ltd UK will discuss utilising a classic “what, where, why, when, who and how” approach to engage with regulatory agencies to validate and adjust plans in a dynamic environment. They will also explore accelerated pathways and incentives and how to prepare for success in attaining these.

The workshop will be interactive with each session beginning by drawing upon experience, ideas and issues faced by the participants before moving into more formal presentations and finishing with a summary of key learning points. Sessions will be designed to address often overlooked or poorly planned issues such as sourcing, distribution and final product delivery (how to get the therapy to and into the patient).

Registration

In addition to attendance at the workshop for one company representative, registration includes:

  • up to three attendees at the module BioBriefing (Tuesday 13 August)
  • a 30-minute advisory session with the module leader for up to four representatives from your organisation (Thursday 15 or Friday 16 August at BioMelbourne Network premises – we will be in touch to advise your meeting time.)
  • an invitation to attend the exclusive BioMelbourne Network Entrepreneur Roundtable Lunches with local business leaders who have succeeded in taking products to global markets.

The fee is $550 (incl. GST) if this is your first Going Global module, or $440 (incl. GST) if you have participated in earlier modules.

Registration confirmation: Please note that places are strictly limited and registration is subject to confirmation by BioMelbourne Network.

Cancellation policy: A full refund is given up to 14 days prior to the module. No refunds within 14 days of the module.


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About our speaker

Tickets

New Participant Going Global$550.00
Returning Participant Going Global$440.00

Details

Date:
August 14
Time:
9:00 am - 5:00 pm
Cost:
$440 - $550
Event Category:

Contact

BioMelbourne Network
Phone:
+61 3 9667 8181
Email:
info@biomelbourne.org

Venue

Sofitel
Collins Place, 25 Collins St, Melbourne VIC 3000
Melbourne, VIC 3000 Australia
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