Tel: +65 65579167 / +86 10 59208165
Fax: +65 62235186/+86 10 59208111
Email: thomas.ooi@neo-edge.com /
steven.li@neo-edge.com
Weblink: http://www.neo-edge.com/Organized by Neo-edge, US FDA Regulatory Policies and Approval Process for IND/NDA/BLA, will take place at Traders Hotel, Singapore, on 1-2 September and Sheraton Hong Kong Hotel & Towers, on 4-5 September 2008 successively.
Featuring real FDA applications and cases, this workshop will enable you to learn and integrate the current regulatory requirements, approval processes, latest initiatives, successful applications, real lessons, new strategies and market trends for your drug/biologics development and business success.
The workshop will be led by Dr. Jim Wei, 10 years’ latest comprehensive FDA experience & the primary reviewer for the first follow-on growth hormone (Omnitrope), and to cater to decision-makers, senior executives and those involved in Regulatory Affairs, R&D, Product / Process Development, Business Development and Partnership across A&P.