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Ready to rollover a compound into a new application? If you have identified a drug that
has been previously approved by the FDA and want to reposition it, then the 505(b)(2)
workshop is for you.
Meet with Ken Phelps, Camargo Pharmaceutical Services, a drug repositioning 505(b)(2)
expert at a one-day workshop.
Date: Thursday, April 10th, 2008
Time: 9am-4pm
Location: South San Francisco, CA
Venue: Marriot – Residence Inn® by Marriott®
San Francisco Airport/Oyster Point Waterfront
1350 Veterans Blvd
South San Francisco, CA 94080
Cost: $250 per attendee, includes lunch
Register: Log-on to www.camargopharma.com/register and register by April 7th, limited attendance.
- The regulatory difference among 505(b)(1), 505(b)(2) and 505j submissions
- The risks and benefits of each type of submission
- The drug development process requirements of a 505(b)(2)
- Candidates for 505(b)(2) submissions
- Timelines and costs of a 505(b)(2) submission
Set-up time for an individual consultation.
Stuck? Experiencing rough waters? Don’t know how to take the first step? The 505(b)(2) submissions
have special requirements; you need the experts at Camargo to guide you through the process. Ken and
his team have years of experience in the full spectrum of drug development—not to mention a thorough
understanding of the FDA and its evolving standards. With your new-found knowledge of 505(b)(2), why
not stay and relax a while in sunny San Francisco.
 Ken Phelps, President and CEO
Ken Phelps used more than three decades of experience in the health science and
services industry to found Camargo Pharmaceutical Services. As an expert in drug
development, specifically the 505(b)(2) regulatory approval pathway, Phelps has
aided in the successful FDA approval of numerous compounds.
Camargo Pharmaceutical develops and executes comprehensive drug development programs tailored to meet the needs of your specific compound. Our expert team has years of experience in the full spectrum of drug development. We manage every facet of your program: formulate and test the drug product, conduct clinical studies, and guide you through the FDA application submission process—specializing in 505(b)(2). Increase your speed-to-market with Camargo as your strategic partner. |
