Inside the FDA's Electronic Revolution: What's Next for Compliance?

Held April 29, 2009

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:

  • Key insights and information revealed in the five interviews with FDA officials
  • The goals and responsibilities of the FDA’s bioinformatics board — and how its five business review boards will oversee the e-transformation
  • What the FDA is doing to centralize its IT decisionmaking structure
  • Five objectives driving the FDA’s move to target enterprise architecture
  • How the data standards council is supporting the e-transformation effort by adopting internationally accredited Health
  • Level Seven standards
  • An inside look at 21 e-initiatives, including MedWatch and a nationwide postmarket drug monitoring system
  • New computational tools the agency will use to conduct safety and efficacy analyses
This audio CD/Transcript is a must for drug and biologic firm employees responsible for ensuring their document management systems meet the FDA’s expectations for electronic submissions, including:
  • Compliance officers
  • Regulatory and legislative affairs
  • IT professionals
  • Medical affairs
  • Outside consultants
  • General and corporate counsel
  • Quality control
  • Business development officers
  • Science officers
  • Executive management
  • Regulatory/legislative affairs professionals
  • General/corporate counsel
  • QA/QC staff
  • Executive management

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

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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