CINCINNATI, Sept. 11 /PRNewswire-FirstCall/ -- Kendle , a leading, global full-service clinical research organization, today announced that its regulatory affairs experts will share their insights on key industry topics at the Regulatory Affairs Professionals Society (RAPS) Annual Conference and Exhibition to be held Sept. 13-16 at the Pennsylvania Convention Center in Philadelphia. Demonstrating its leadership position in providing regulatory guidance to its global pharmaceutical customers across the Phase I through IV clinical development process, Kendle has been selected to lead five sessions at the conference.
(Logo: http://www.newscom.com/cgi-bin/prnh/20080923/CLTU095LOGO) Kendle's presentations include: "New Pregnancy and Lactation Labeling Rule Revisions" Monday, Sept. 14, 11 a.m.-Noon Lisa Jenkins, PhD, Group Leader, Regulatory Consulting and Submissions "Drug/Biologic Preapproval Inspection (PAI) - A Survival Guide" Monday, Sept. 14, 1:30-3 p.m.
Hari Nagaradona, PhD, Associate Director, Regulatory Consulting and Submissions
"Adaptive Clinical Trial Designs That Get Results" Monday, Sept. 14, 1:30-3 p.m. Lisa Jenkins, PhD, Group Leader, Regulatory Consulting and Submissions
"The Expanding Role of Regulatory Advice: Guidance meets Business Development Professional " - Panel Discussion
Monday, Sept. 14, 1:30-3 p.m.
William Sietsema, PhD, Vice President, U.S. Regulatory Consulting and Submissions
"Ethical Standards in Clinical Research" Tuesday, Sept. 15, 3:30-5 p.m.
William Sietsema, PhD, Vice President, U.S. Regulatory Consulting and Submissions
Kendle at Booth #706
Kendle experts will be available for on-site meetings and to discuss the Company's full suite of regulatory affairs capabilities at booth #706 in the exhibition hall.
Kendle offers extensive regulatory affairs experience, including delivery of all types of projects from global submissions to specialist consulting services. The Company provides expertise and advice at every stage of the drug development process, from early development to market and beyond. Kendle can ensure a product's development is conducted efficiently and in a timely manner, ensuring its smooth transition into the marketplace. The Company's Regulatory Affairs experts understand the commercial imperatives underlining decisions such as where to submit first, or which regulatory route to follow in a particular region, and work with biopharmaceutical companies worldwide to design an appropriate strategy for any product anywhere in the world.
Kendle offers customers global regulatory centers of expertise around the world to meet their needs. These integrated locations include Rockville, Maryland and Cincinnati, Ohio in the United States; Ely, England and Edinburgh, Scotland in Europe; Sydney and Melbourne, Australia in the Asia/Pacific region; and Mexico City, Mexico in Latin America.
About Kendle
Kendle International Inc. is a leading global clinical research organization providing the full range of early- to late-stage clinical development services for the world's biopharmaceutical industry. Our focus is on innovative solutions that reduce cycle times for our customers and accelerate the delivery of life-enhancing drugs to market for the benefit of patients worldwide. As one of the world's largest global providers of Phase I-IV services, we offer experience spanning more than 100 countries, along with industry-leading patient access and retention capabilities and broad therapeutic expertise, to meet our customers' clinical development challenges.
Additional information and investor kits are available upon request from Kendle, 441 Vine Street, Suite 500, Cincinnati, OH 45202 or from the Company's Web site at http://www.kendle.com/.
Kendle International Inc.
CONTACT: Michael Lawson, Investors, +1-513-763-1992, Lori Dorer, Media,
+1-513-345-1685, both of Kendle International Inc.
Web Site: http://www.kendle.com/
