Invivodata, Inc. Announces Agenda and Faculty for Outcomes Assessment Conference
Published: Jan 17, 2012
By attending PROficiency 2012, clinical researchers will have access to current, critical information on the regulations and practical considerations of selecting, implementing, and justifying all OAs to ensure they are fit for purpose and appropriate for their context of use. With a combination of general assemblies and sessions following tracks pertaining to the use of OAs in both Phase 2/3 and late stage research, attendees can customize the conference to suit their needs and specific interests.
“We’ve designed the conference agenda to address the many questions clinical researchers have about recent regulatory changes pertaining to selecting, evaluating, and providing evidence to support endpoints for their clinical development programs,” said Dr. Jean Paty, invivodata Co-founder and Chief Scientist and Regulatory Advisor. “We are thrilled to have these discussions led by a faculty comprised of knowledgeable, international biopharmaceutical developers and researchers with specific experience and insight to the Food and Drug Administration (FDA) and European Medicines Agency (EMA).”
Joining scientists from invivodata and its regulatory consulting division, PRO Consulting®, the faculty for PROficiency is comprised of international biopharmaceutical and industry experts, including:
- Olivier Chassany, MD, PhD, Medical Head of the Department of Clinical Research and Development, Assistance Publique - Hôpitaux de Paris
- John H. Powers III, MD FACP FIDSA, 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
- Michael Hufford, Ph.D., Chief Operating Officer, NeuroCog Trials
- Maria Diviney, Principal Data Manager, Global Data Science, Astellas Pharma Europe B.V.
- Sean Stanton, Co-Founder & Owner, Compass Research, LLC
“Our objective is for attendees to walk away from the conference with knowledge of the scientific and regulatory considerations of capturing patient perspective in clinical development,” said Bob Young, invivodata Chief Operating Officer. “We are confident that the practical topics being presented will provide attendees with valuable information that can be used day-to-day in their clinical research, whether their key stakeholder is a regulatory body or a reimbursement organization.”
invivodata is offering 30% off registration fees for attendees who register before February 13, 2012. For additional information and to register for PROficiency 2012, please visit http://www.invivodata.com/proficiency-2012.
invivodata is the only fully-integrated Outcomes Assessments (OA) organization delivering regulatory-proven strategic consulting and practical electronic solutions to biopharmaceutical companies who depend upon patient-centered research. From reliable and scientifically sound consulting that helps research teams effectively develop, execute, and document OA strategies to electronically collecting OA data in global clinical development programs, invivodata helps its customers strategically use patient-, clinician-, and observer-reported data to support labeling claims, enhance reimbursement strategies, and meet other clinical program objectives. Through partnerships with leading CROs and eClinical technology providers, invivodata seamlessly integrates into the clinical trial ecosystem, helping to minimize operational risk and maximize efficiencies. invivodata’s electronic solutions and strategic consulting services have been used in over 600 clinical programs and are built upon the industry-leading ePRO system in delivering primary efficacy data for global drug approvals. invivodata inc. is a privately held company with global headquarters in Pittsburgh, PA., USA; its European headquarters is in London, England; and its technology development center is in Scotts Valley, CA., USA. For more information, visit www.invivodata.com