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10009 Cardiovascular Safety in Drug Development: QT, Arrhythmias, Thrombosis, and Bleeding
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Title:
Cardiovascular Safety in Drug Development: QT, Arrhythmias, Thrombosis, and Bleeding
Date(s) And Time(s):
Apr 11 2010 9:00AM - Apr 13 2010 5:00PM
Location:
Sheraton National Hotel Arlington
900 South Orme Street
Arlington, VA 22204
Interest Area(s):
Clinical Safety/Pharmacovigilance,Clinical Research,Document Management/ eSubmissions,Nonclinical,Quality Assurance/Quality Control,Regulatory Affairs,Research & Development
Overview:
New Directions, Practical Challenges, Possible Solutions, and Regulatory Approaches in the Development of Pharmaceutical Agents.
This conference, co-sponsored by the FDA and the Heart Rhythm Society, will bring together FDA, PMDA, industry, academic, and global regulatory speakers in an open forum. The sessions will include in-depth discussion of the evolution of drug development, cardiac QT issues, cardiovascular safety, and strategies for analyzing and mitigating potential risks to improve cardiac safety analysis during drug development. Featuring close interaction with FDA policy-makers and industry and academic experts, this has become the premier conference for keeping current in this field.
Featured Session Topics:
• Preclinical Testing and QT/Torsade de Pointes Assessment
• Thorough QT Study - Key Issues
• ICH E14 Issues Under Consideration
• CV Safety Unrelated to QT
• Debate: Automatic QT Assessment Will Replace Manual and Semi-Automatic QT Techniques for the Thorough QT Study
• Abstract Presentations
Learning Objectives:
At the conclusion of this meeting, participants should be able to:
• Recognize the state-of–the-art approach to performing the thorough QT study, including novel trial designs, the statistical analysis of the positive control agent, the definition of adequate assay sensitivity, and issues of multiplicity
• Describe how to evaluate drugs for CV risk
• Explain how new preclinical or clinical biomarkers can gain regulatory acceptance;
• Identify how to optimally use preclinical data to assess CV risk
• Discuss the use of automatic QT Measurements
• Explain the major issues in clinical CV safety evaluation.
Target Audience:
Who Should Attend
• Academic scientists
• Industry management
• Clinical project physicians
• Quality assurance directors
• Preclinical/discovery scientists
• ECG safety data managers
• ECG lab and equipment vendors
• Regulatory specialists
• Clinical project management
• Safety assessment personnel
Event Code:
10009
Contact Information:
Contact Ben Zaitz at the DIA office by telephone 215.293.5803, fax 215.442.6199 or email Benjamin.Zaitz@diahome.org.
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Physician Continuing Medical Education
Accreditation Statement
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and Drug Information Association (DIA). PIM is accredited by the ACCME to provide continuing medical education for physicians.
Credit Designation
Postgraduate Institute for Medicine designates this educational activity for a maximum of 13.75 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Day 1 Tutorial: 6.5 AMA PRA Category 1 Credit(s)™
Day 2 Meeting: 7.5 AMA PRA Category 1 Credit(s)™
Day 3 Meeting: 6.25 AMA PRA Category 1 Credit(s)™
ACPE: The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this activity as follows:
Tutorial: 6.5 contact hours or .65 CEUs; 286-000-10-014-L04-P
Meeting: 14.25 contact hours or 1.425 CEUs; 286-000-10-013-L04-P
Type of Activity: Knowledge
| TUTORIAL: An Introduction to Clinical Assessment o | ACPE
CME
| 6.50
6.50
| 0.650
| | Cardiovascular Safety in Drug Development: QT, Arr | ACPE
CME
| 14.25
13.75
| 1.425
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Disclosure Policy:
It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials.
Statement of Credit:
To receive a statement of credit, participants must attend the program and complete the online credit request process through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request. Complete details and instructions for accessing My Transcript will be included in the final program.
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The most convenient airports are Reagan National and Washington-Dulles International Airport and attendees should make airline reservations as early as possible. The Sheraton National Hotel is holding a block of rooms at the reduced rate below until March 19, 2010, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.
Single $215 Double $215
Attendees must make their own hotel reservations. Contact the Sheraton National Hotel by telephone at +1.800.325.3535 and mention the DIA event. The hotel is located at 900 South Orme Street, Arlington, VA 22204, USA.
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Meeting
| Charitable Nonprofit/Acad | $650.00 | | Industry | $1295.00 | | Government (Full Time) | $390.00 | | One Day Rate | $750.00 |
Additional Offerings:
| TUTORIAL: An Introduction to Clinical Assessment o - Standard Rate | $710.00 |
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