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ComplianceOnline, Online Event
2012-12-13
Why Should You Attend: A patient-reported outcome (PRO) is “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” Use of such outcome measures has recently increased as PROs have gained greater credibility and can play an important role in drug approval. Regulatory bodies in the US and EU have released guidelines aiming to standardize PRO use and interpretation in clinical trials supporting medicinal product submissions. This webinar provides an overview of the philosophy and assumptions underlying the use of PROs, current perspectives and guidance for their use in clinical trials. Areas Covered in the Webinar: - PRO instruments: Conceptual framework, endpoint models.
- Reliability, Validity, and Sensitivity.
- Existing instruments, modified instruments, and newly created instruments. Types of evidence needed for FDA review.
- Protocol Considerations.
- Electronic Data Capture.
- Multiple and Composite Endpoints.
- Statistical Considerations: SAPs
- Interpretation of Clinical Trial Results.
Who will Benefit: Professionals who will benefit from this webinar include: - Pharmaceutical and Medical Device Company Representatives and Decision-Makers
- Clinical Research Professionals
- Clinical Protocol Developers
- Clinical Study Managers
- Regulatory Managers
- Clinical Studies Directors
- Biostatisticians
- Anyone seeking to design appropriate clinical investigations for supporting anticipated labeling for a new drug or medical device.
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Organized by:
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Complianceonline |
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Invited Speakers:
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Dr. Hanover, has worked in clinical research for over 30 years, as a Principal Investigator for studies funded by national agencies such as NIMH, Veteran’s Affairs, and DOD as well as various private pharmaceutical and medical device companies, as a Professor teaching research methods, biostatistics, and evidence-based medicine at the University of Utah School of Medicine, a Consultant to the Utah State Department of Health, and Director of Clinical Research for Technician Medical Systems. She has concurrently held consulting positions for such companies as Pherin Pharmaceuticals, Utah Cancer Specialists, Montgomery-Watson Environmental Engineering, and Planned Parenthood Federation of America. She earned a Regulatory Affairs Certification (RAC) in 2006 through RAPS, and is also a member of the Society of Clinical Research Associates (SOCRA), and the American Statistical Association (AMSTAT).
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Deadline for Abstracts:
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2012-12-12
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Registration:
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For Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702564?channel=hummolgen
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E-mail:
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referral@complianceonline.com
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