Camargo Pharmaceutical Services announces its plans to host a one-day workshop on April 10, 2008 in South San Francisco focused on the FDA approval pathway known as 505(b)(2). Ken Phelps, an industry expert in 505(b)2 approvals, is the president and CEO of Camargo Pharmaceuticals. Phelps will speak with attendees on the topic of drug repositioning, approval pathways within the FDA—specifically the regulatory differences between 505(b)(2) and other submissions.
"The workshop is a unique opportunity to meet one-on-one with attendees to truly learn the in's and out's of drug repositioning. We've spent numerous years in the industry and have many successful FDA submissions to our credit. There is a distinct process to repositioning a drug that has already been approved by the FDA," said Phelps.
Camargo Pharmaceutical Services offers scientific and regulatory drug development services for mid-sized pharmaceutical, biotechnology and drug delivery companies. With more than 150 FDA approvals, Camargo works with companies to develop comprehensive programs, managing every facet of the plan from formulation and testing the drug product, conducting clinical studies, and FDA application submissions. The chief scientific officer has also served as a team leader and reviewer in the new drug division of the U.S. Food and Drug Administration (FDA).
More Information on the 505(b)(2) Workshop:
505(b)(2) ON THE BAY
Date: Thursday, April 10th, 2008
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 for more information or to register by April 7th, limited attendance.
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services focuses on strategic drug development program design and implementation, from end-to-end or at any intermediate stage. The services include pre-clinical feasibility assessments, CMC and CMO services, clinical program development, pharmacokinetics, CRO services, Phase I through IV studies and clinical trials, and regulatory review and submission via eCTD of INDs, NDAs, ANDAs, and 505(b)(2)s. Tel: 888/451-5708 or