February 21, 2008 — /NORWALK, CT/ — The producers of the PharmaMedDeviceTM Conference & Exhibition announced today that the 2008 conference program, March 26-28, 2008 in Philadelphia, will feature AdvaMed’s world class Medical Technology Learning Institute (MTLI) workshop. As the educational arm of AdvaMed, the world’s leading medical technology industry trade association, MTLI teaches professionals the skills necessary to manage the business, regulatory, legal, and payment issues affecting the medical industry. Providing more than three hours of hands-on regulatory training, the MTLI continuing education workshop will complement and extend the value of PharmaMedDevice’s robust 2008 conference program.
As the first event to address the comprehensive needs of the converging medical device, pharmaceutical and biologic industries, PharmaMedDevice is heavily focused on helping drug and medical device companies address and meet the unique regulatory challenges associated with developing combination products. In line with the PharmaMedDevice conference theme, the AdvaMed MTLI session will specifically focus on helping attendees prepare for and manage FDA inspections. The session will take place March 27 from 1:30 p.m.-5:00 p.m. as part of the PharmaMedDevice conference program, and will provide a combined industry and legal perspective.
“Combination product developers are adding a new dynamic to our membership and developing innovative products to advance patient care,” says Tom Maeder, executive director of MTLI at AdvaMed. “Participation in the PharmaMedDevice conference will raise awareness of our association among professionals in this promising area of medical technology. As an endorser of PharmaMedDevice, we look forward to conducting a successful and well-attended workshop at the 2008 event.”
MTLI workshop participants will learn what to expect during inspections, how best to prepare for them, and what company personnel and resources should be present. They also will learn how to manage inspections, what materials should be made available to investigators, and some of the issues that may arise. Key do’s and don’ts of responding to 483s and warning letters, and ways to resolve or appeal disputed issues will also be addressed.
An impressive line up of professionals from FDA, the industry, and law firms will conduct the workshop. Speakers include Janice Hogan, partner, Hogan and Hartson LLP; Karyn M. Campbell, assistant director, investigations branch, FDA; Rob Newman, VP quality and regulatory affairs, Electocore Medical; and Robin Fatzinger, vice president, Kensey Nash Corporation.
“This premier MTLI workshop at PharmaMedDevice is indicative of our growing relationship with AdvaMed and the depth of our conference program,” says Christina Lorelli, conference manager, PharmaMedDevice. “We are pleased to have such a well-respected association share its expertise with our participants. The MTLI session will provide even greater reason for leading medical device, diagnostic product and health information system companies to attend PharmaMedDevice.”
PharmaMedDevice’s comprehensive conference program will provide insightful education on a wide spectrum of topics, ranging from regulatory issues and investment trends to nanobiotechnology and regenerative medicine. Developed in conjunction with the editors of FDC Reports’ “The Gray Sheet” and “The Pink Sheet,” the PharmaMedDevice conference program offers four tracks that address the multi-dimensional nature of the combination product market, including regulatory issues, manufacturing challenges, innovative technologies, and research and development.
AdvaMed member companies produce the medical devices, diagnostic products, and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States, and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies.
PharmaMedDevice is a forum that fully illuminates the convergence of the medical device, pharmaceutical, and biologic industries. The second annual PharmaMedDevice will be co-located with INTERPHEX at the Pennsylvania Convention Center in Philadelphia on March 26-28, 2008. Pharmaceutical and medical manufacturers will converge at these two events to find answers to their regulatory challenges, create new partners, and source solutions for new product development.