PHILADELPHIA, PA – January 18, 2013–– ERT, a global technology-driven provider of health outcomes research services to biopharmaceutical organizations, medical device companies and contract research organizations (CROs), has provided updated information on PROFICIENCY™ 2013: Maximizing Product Value with Optimized Endpoints, its 6th annual educational conference. The conference is being held April 10-12, 2013 in Ft. Lauderdale, FL. Updated conference information, including a complete program agenda and expanded list of international speakers can be found at www.ert.com/resources/seminars/.
The conference will focus on how pharmaceutical companies can demonstrate the efficacy and value of their products to key stakeholders throughout the drug development lifecycle. The agenda is comprised of topics pertaining to the collection of high-quality patient safety and efficacy data, with a concentration on the use of Clinical Outcome Assessment (COA) data – including Patient, Clinician, and Observer Reported Outcomes (PROs, ClinROs and ObsROs).
PROFICIENCY 2013 will also provide important updates on the FDA’s recently revised Guidance for Industry on the Prospective Assessment of Suicidal Ideation & Behavior in Clinical Trials.
Joining scientists and regulatory experts from ERT (formerly invivodata), the faculty for PROFICIENCY is comprised of international biopharmaceutical, regulatory, and industry experts, including this sampling of confirmed speakers to-date:
• Olivier Chassany, MD, PhD, Medical Head of the Department of Clinical Research and Development, Assistance Publique - Hôpitaux de Paris
• Tom Laughren, MD, Director, Laughren Psychpharm Consulting (Formerly with FDA)
• Deborah Collyar, President, Patient Advocates in Research (PAIR)
• Ronald Chen, MD, Assistant Professor of Radiation Oncology, University of North Carolina
• Florian Turk, PhD., Executive Director, Global Head HEOR, Novartis Pharma AG
“We’re very excited to offer attendees the opportunity to network with international experts who can address their questions on the effective use of endpoints throughout all stages of clinical development,” said Dr. Chad Gwaltney, Senior Director, Consulting Services at ERT. “Attendees will come away from the conference with knowledge of the scientific, regulatory, and commercial considerations of capturing patient safety and efficacy data – practical information that can be used day-to-day in their clinical research.”
ERT is offering 30% off of conference fees for attendees who register before Feb.15, 2013. For more information and to register, visit www.ert.com/resources/seminars.
ERT (www.ert.com) is a global technology-driven provider of health outcomes research solutions and services supporting biopharmaceutical and medical device organizations to achieve their new medical product development and commercialization objectives. ERT harnesses leading technology coupled with reliable processes and scientific/regulatory expertise to collect, analyze and report on clinical trial data to support the determination of health outcomes critical to the approval, labeling and reimbursement of pharmaceutical and new medical products. ERT is the acknowledged industry leader in centralized cardiac safety, respiratory efficacy services, scientific and regulatory consulting, and Clinical Outcome Assessment (COA) solutions, which includes patient, clinician, and observer reported outcomes. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.