Including Europe in your Strategy to add value to early-stage Biotech products (Strategic Value of i)

Venue: Green V Sustainable Center

Location: South San Francisco, California, United States

Event Date/Time: Sep 15, 2009 End Date/Time: Sep 15, 2009
Registration Date: Sep 10, 2009
Early Registration Date: Aug 12, 2009
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The primary goal of most smaller biotech companies is to develop a product to a stage where additional funding can be attracted or partnering becomes feasible. Therefore, the focus of the company should be to add as much value as possible to the project during early development. Value is partly based on the achievement of regulatory milestones. This seminar will provide practical advice towards maximizing the potential of development programs from the European regulatory perspective. This seminar will highlight the value of a European regulatory strategy, alongside the primary strategy for the US, and the opportunities this can offer, without significant additional investment of resources. This can contribute towards making your company a more attractive proposition for investment and/or partnering.

Topics covered include:
• The value of including an EU component into your overall regulatory strategy
• Optimizing interactions with European regulators and how this can aid development and add value
• The benefits of orphan medicinal product designation in the EU and an explanation of the procedure
• Clinical Development in the EU: The European Clinical Trials Directive
• Opportunities in the EU regulatory framework to add value and reduce time to approval, such as accelerated review, conditional approval or exceptional circumstances
• Compassionate use programs

This is an exciting half-day workshop for regulatory professionals, project managers, product development team members in the biopharmaceutical industry


1 Chestnut Avenue
United States

Additional Information

For cost and registration please visit our website and download the flyer. We also offer a second course (Regulation of Advanced Therapy Medicinal Products – from clinic to market) at the same location on 9/14/09