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As biotech executives and research institutes plan their development strategies they need to carefully plan their late phase clinical development and market entry strategies.
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Our July BioBreakfast brings together a panel of CRO consultants and Industry practitioners to provide an overview of market entry and clinical strategic planning.
Kendle Australia's Director- Regulatory Development & Commercialisation Ms Judy Bingham and Acrux Pty Ltd Director Clinical Development, Dr Tina Soulis will examine the following:
Market entry strategy
Product Competitiveness
Which countries / which regulatory agencies?
Labelling, Target Product Profile
Interpreting early phase data and the design of Phase III program
Getting ready for phase III
Which countries?
Which sites?
The role and timing of feasibility
Role of Key Opinion Leaders
Timelines and budget
Product Availability
Registrations received after the RSVP date cannot be accepted.
Venue: Supper Room, Melbourne Town Hall
Registration - from 7.15 am. Networking 7.20 am - 7.55 am.
Presentation and Breakfast commences 8.00 am sharp.
BioBreakfast concludes 9.00am.
RSVP DEADLINE - By 10.00am, Wednesday July 9th . 2008.
NOTE: Speakers and topics may change without notice.
Due to the popularity of our BioBreakfasts, Network Members have priority.
Nicole Pitcher: Administration Coordinator, email: npitcher@biomelbourne.org, tel: 9650 8800