ERT Opens Registration for PROFICIENCY™ 2013 Annual Conference

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International biopharma and regulatory professionals deliver practical information on how high-quality patient safety & efficacy data can demonstrate value throughout the product lifecycle.

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Attendees will have access to current, relevant information, as presented through the perspective of international regulators, payers, researchers, physicians, and patients.”

ERT, a global technology-driven provider of health outcomes research services to biopharmaceutical organizations, medical device companies and contract research organizations (CROs), today opened registration for PROFICIENCY™ 2013: Maximizing Product Value with Optimized Endpoints – its 6th annual conference. The conference will focus on demonstrating product value to key stakeholders throughout the development lifecycle with the collection of high-quality patient safety and efficacy data, and will be held April 10-12, 2013 at the Marriott Harbor Beach Resort & Spa in Fort Lauderdale, FL.

“We’re very excited about the broad range of educational opportunities that are available for this year’s conference attendees, “said Dr. Chad Gwaltney, Senior Director, Consulting Services at ERT. “By participating in PROFICIENCY 2013, attendees will have access to current, relevant information, as presented through the perspective of international regulators, payers, researchers, physicians, and patients.”

The conference will focus on the importance of collecting 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 (PRO, ClinRO and ObsRO). 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.

Attendees will come away from the conference with knowledge of the scientific, regulatory, and commercial considerations of capturing patient safety and efficacy data in all phases of clinical development. PROFICIENCY 2013 will cover a variety of topics that are relevant to the day-to-day objectives of biopharmaceutical developers, including the value of endpoints across the product lifecycle, improving the quality of safety and efficacy endpoints through electronic data capture methods, and how improving quality of spirometry data can increase efficiencies in respiratory studies. General assemblies and track sessions will be led by international biopharmaceutical professionals and industry experts, including the following sampling of confirmed speakers to-date:

  • Dr. Florian Turk, Executive Director, Global Head Health Economics & Outcomes Research, Critical Care Business Franchise, Novartis Pharma AG, Switzerland
  • John H. Powers III, MD FACP FIDSA, Physician/Investigator on faculty as the Associate Clinical Professor of Medicine at the George Washington University School of Medicine and former Lead Medical Officer for Antimicrobial Drug Development and Resistance Initiatives in the Office of Antimicrobial Products, Center for Drug Evaluation and Research, at the US Food and Drug Administration
  • Frank Carillo, President and Managing Director, ECG, Inc.
  • Saul Shiffman, Ph.D., Professor of Psychology (Clinical and Health Psychology), University of Pittsburgh, Senior Scientific Advisor, Pinney Associates & Senior Scientific Consultant, ERT
  • Jean Paty, Ph.D., Chief Scientist and Regulatory Advisor, Outcomes, ERT
  • Chad Gwaltney, Ph.D., Senior Director, Consulting Services, ERT

PROFICIENCY 2013 enables biopharma professionals to share their experiences and learn from leading industry experts as they advance their knowledge of patient safety and efficacy data in research. After attending last year’s conference, a Manager of Clinical Operations at BioCryst Pharmaceuticals commented, “This is a great opportunity to network and hold real discussion with colleagues. It’s a very personal conference, not a mega-meeting.”

ERT is offering 30% off of conference fees for attendees who register before Feb.15, 2013. For more information and to register, visit

About ERT
ERT ( 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.

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Christine Tobin
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