US Conference on Rare Diseases & Orphan Products: Shaping the Future Now

Register by October 1 to Save US Conference on Rare Diseases & Orphan Products: Shaping the Future Now October 22-24 | Washington, DC Co-sponsored by NORD Register by October 1 to Save! The US Conference on Rare Diseases and Orphan Products features keynote presentations, high-level plenary and smaller group sessions, including comprehensive coverage of today's hottest topics in sessions intended to promote advancements in science, care, and other considerations that will address the needs of the 30 million Americans with rare diseases.  Day 2 Keynote Speaker: Stephen P. Spielberg, MD, PhD Deputy Commissioner, Medical Products and Tobacco Office of the Commissioner Food and Drug Administration Featured Session Topics:      • Access and Reimbursement      • Challenges of Reimbursement for the Rare Disease Patient      • Comparative Effectiveness Research and Health Technology Assessments (HTA)      • Facing the Crisis in Biomedical Innovation: A Venture Investor’s Perspective      • Impact of FDASIA on Orphan Product Development      • Investing in Orphan Products: Is the Environment getting Better Or Worse      • Natural History Studies      • New Relationship with the Patient Community – FDA and the Patient      • New Relationship with the Patient Community – Industry and the Patient      • NIH Updates      • Postmarketing Period-Opportunities for Continued Learning      • Shaping the Future of Health Policy Now      • Working with the FDA   Program Overview Table Top Exhibit Opportunities: Showcase your company's products and services. Submit your application today to Shannon Lewis. Special Offer: Register for both US Conference on Rare Diseases & Orphan Products and Clinical Trial Endpoints: Methods and Practice in Developing Measurements – and Save Up to $500!*  Stay Connected with DIA One-Day Interactive Workshop with a Special Emphasis on Rare Diseases Clinical Trial Endpoints: Methods and Practice in Developing Measurements October 25 | Washington, DC This one-day interactive workshop with special emphasis on rare diseases will provide a detailed examination of the process for developing, validating, and implementing patient-focused clinical trial outcome measures that will meet regulatory requirements for adequate and well-controlled clinical trials, product approval, and labeling. Register by October 4 to Save!   Program Overview | Register Now *Offer expires October 1 and only applicable to the Industry rate. You must register for both events at the same time. Already registered for one of these events? Contact Customer Service

DIA Worldwide Headquarters
800 Enterprise Road, Suite 200
Horsham, Pennsylvania 19044-3595
T. +1.215.442.6100
F. +1.215.442.6199

PCORI hosts 3 workshops in Washington, DC

The Patient-Centered Outcomes Research Institute (PCORI) will host three workshops in Washington, D.C., this fall as part of its effort to engage patients and other health care stakeholders as meaningful and active partners in its efforts to build a patient-centered research community and refine its research agenda.   The workshops are designed to obtain input from patients, caregivers and other stakeholders on PCORI's draft process for generating and selecting specific research topics. Once implemented, the process will lead to topic-specific funding announcements that correspond to the five priority areas for research outlined in PCORI's National Priorities for Research and Research Agenda and complement the broad Funding Announcements that PCORI issued in May.    Each workshop is designed to encourage participation from a specific group within the health care community. Attendance will be limited, but each workshop will be accompanied by a public, interactive webcast. PCORI is prepared to support travel and related expenses of invited attendees.      Workshops:   Transforming Patient-Centered Research: Building Partnerships and Promising Models October 27-28 This workshop will focus on the patient's role and perspective in PCORI's work, and provide an opportunity for patients, caregivers, advocacy groups, researchers and other stakeholders to start working together as a community to discuss potential ideas for future research. It also will support PCORI's efforts to raise the standards in the science of patient engagement by developing promising policies for identifying research questions, reviewing funding proposals and ensuring patient participation throughout the process. Attendance is limited to 150 people; 75% of workshop invitations will be reserved for patients, caregivers and organizations representing them.    What Should PCORI Study? A Call for Topics from Patients and Stakeholders December 4 This workshop will be an opportunity to solicit recommendations for specific research topics and test PCORI's draft process for determining which could be the basis of future funding announcements. Attendance is limited to 100 individuals; 25% of invitations will be reserved for patients, caregivers and the organizations that represent them.   PCORI Research Prioritization Methods Workshop  December 5 Research methodologists, patients and stakeholders will further test the process for selecting research questions and address a number of methodological issues that will help PCORI refine the process to ensure that it addresses the needs of patients and those who care for them. Attendance will be invitation only and limited to 50 individuals due to the event's format.    More information about each workshop is available on the PCORI website.   About PCORI The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.        Patient-Centered Outcomes Research Institute | 1828 L Street, NW, | Suite 900 | Washington | DC | 20036

 

FDA: Navigating the changes with professional development

The Food and Drug Administration Safety and Innovation Act (FDASIA) is Law. Now What?  Join DIA, Food and Drug Administration (FDA), and The Food and Drug Law Institute (FDLI) as they convene the foremost experts in separate conferences to explain the nuances and forecast the implications of the User Fee Acts—PDUFA V, MDUFA III, GDUFA, and BsUFA. DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA September 12-13 | Washington, DC Co-sponsored by In 2009, the Biologics Price Competition and Innovation Act (BPCI Act) was enacted as part of the Affordable Care Act. This conference will deal with the scientific and regulatory issues related to the demonstration of biosimilarity, focusing both on the FDA’s current thinking on approaches to biosimilar development as well as perspectives of other regulators. Hotel Early-Bird Rates End August 27! In collaboration with Keynote Speaker: Janet Woodcock, MD Director, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA) View Program Online | Register Today Unwrapping FDA's 2012 UFA Package: What's Inside the Statute, What's Next? September 20 | Washington, DC Co-sponsored by The content of the UFA packages will shape the timeliness of reviews of life-saving medicines and medical devices, the requirements of all phases of medical product development, and the industry’s ability to innovate and develop needed medical products. This one-day conference will provide a first look at the final packages enacted for PDUFA V, MDUFA III, GDUFA and BsUFA. FDA will discuss the goals and commitments for their Centers, the changes of emphasis, and the potential impact on future programs. Reactor panels will provide the exchange of views on what the UFA provisions will mean for innovation, how they will improve patient access to needed medical products over the next five years, and next steps in preparing for 2017. Keynote Speakers: Jeanne Ireland Assistant Commissioner for Legislation Food and Drug Administration (FDA) Jeffrey E. Shuren, MD, JD Director, Center for Devices and Radiological Health (CDRH) Food and Drug Administration (FDA) View Program Online | Register Today DIA/FDA Industry PDUFA V Conference October 18-19 | Arlington, VA Co-sponsored by With the recent authorization of PDUFA V, this two-day conference sets the stage for FDA, industry, patient, consumer, and healthcare professional group representatives, and technology vendors to discuss the key PDUFA V commitments, current plans for their implementation, and potential impact on all stakeholders. Keynote Speakers: Theresa M. Mullin, PhD Associate Director, Office of Planning and Informatics Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA) David Wheadon, MD Senior Vice President, Scientific and Regulatory Affairs PhRMA   View Program Online | Register Today My DIA    |    Forward to a Friend    |