The FDA's New Requirement for Electronic Regulatory Submissions: Will You Be Ready by June 2009?

Held Oct. 8, 2008

In less than a year, the FDA will require all drug establishment registrations and drug listing information to be submitted electronically — and, for the first time — this includes makers of biologics, vaccines and OTC products. A waiver from the HHS secretary is the only way to be exempt.

This means that although you’re already sending your labeling content electronically, you’ll have to enhance your existing structured product labeling (SPL) system to handle the newly required information. And manufacturers who currently rely on the three-paper form will have to purchase software, pay for employee training on the new process, or outsource it entirely.

To make matters worse, more mandates may be on the way! Congress is considering giving the FDA control over the removal of products from the market whose manufacturer hasn’t complied with the new electronic submission requirements.

Does your firm have the infrastructure to meet these new mandates? Do you know if it would be better to outsource or purchase expensive software and go through the process of training staff?

Find out everything you need to know as SPL expert Keith Thomas conducts this 90-minute audio CD/Transcript.

Keith will detail the new rules and thoroughly explain the process you’ll need to go through to ensure you’re ready to handle these new requirements.

With less than one year remaining, you won’t want to miss out on this great opportunity to get your company up to speed and be fully prepared to comply with the FDA’s new requirements.
Order today to listen in and discover:

  • Details of the new information that must be submitted
  • The five main requirements of an establishment registration submission
  • The seven main requirements of a drug listing information submission
  • The “murky” areas — information the FDA thinks it can require but may not have the authority to do so
  • The FDA’s current thinking on implementing the new requirements
  • The most important elements of a capable SPL system
  • Whether in-house or outsourced expertise is the better option
  • The history of SPL and the origins of the new submission requirements in the FDA Amendments Act and FDA proposed rules
  • More changes that may be on the way

Discover precisely what information is subject to the electronic registration requirements and what you’ll need to do to comply.

This audio CD/Transcript is a must for contract manufacturers as well as positions in drug and biologic companies, including:

  • Compliance officers
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
  • Quality control personnel
  • IT professionals
  • Outside consultants
  • Management
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Keith Thomas is the product strategist for i4i, a designer and developer of collaborative content solutions and technologies. He is also a member of the joint PhRMA/HL7/FDA SPL Implementation Working Group and an adjunct member of the graduate faculty at the University of Toronto.

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