An opportunity like this rarely comes around — and those that jump on the board can outflank their competitors. Industry advisor Daniel Matlis obtained interviews with five key FDA officials who know where 21 game-changing IT initiatives stand — and how they will affect compliance.
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”
Dan shares these experts’ insights on new FDA e-programs — many of which haven’t been publicly announced yet — goals, tools, standards and expectations.
Order now and you’ll 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.
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