The FDA's New Requirement for Electronic Regulatory Submissions: Will You Be Ready by June 2009?
Product Details
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 Encore presentation.
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.
Sign up your entire team 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