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With 21 IT programs under way, the FDA’s “electronic revolution” is imminent. But are you positioned to seize new opportunities — like speeding up label negotiation via real-time online interaction with FDA review staff and reviewing SOPs online with investigators?
Are you prepared for new challenges — like adapting to the powerful new role of the bioinformatics board and aligning your operations with target enterprise architecture?
Clearly, there’s no time to lose in getting up to speed on all 21 IT programs and the FDA’s new mindset.
Here’s where to start ...
From five FDA officials: early warning on “e-compliance”
Now, in this 90-minute Encore presentation, Dan shares these experts’ insights on new FDA e-programs — many of which haven’t been publicly announced yet — goals, tools, standards and expectations.
Sign up your entire team to know what to expect from the FDA’s electronic revolution, including:
Daniel Matlis is the founder and president of Axendia — a consultancy firm that focuses on providing trusted advice to life science executives on business, technology and regulatory issues. Dan’s 18 years of experience in the life sciences industry has included projects in research and development, manufacturing, regulatory compliance, business development and information technology. Prior to founding Axendia, Dan was vice president and general manager at Stelex, a leading consultancy to life science companies. He started his professional career at Ethicon, a Johnson & Johnson company.
|Date:||May 4–22, 2009|
|Location:||Your office or conference room (no need to travel!)|
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