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10729 Medical Device Safety Reporting
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Title: Medical Device Safety Reporting
Overview:
A Kaplan EduNeering course
This course will introduce the learner to the regulatory requirements in the medical device clinical trial and post-marketing environments, as well as explore device safety monitoring and reporting efforts in Europe.
Topics include: · Definition · Safety · Adverse Events · Pre-market · Marketed devices · Reports
Event Code: 10729
Contact Information:
Linda Belmont at DIA
Tel +1-215-293-5818
Email linda.belmont@diahome.org
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eLearning
Group Discounts:
When purchasing multiple Kaplan EduNeering eLearning modules in one transaction, the following discount prices apply:
· 1 to 2 modules are $99.00 each
· 3 to 4 modules are $89.00 each
· 5 to 9 modules are $80.00 each
· 10 or more modules are $65.00 each
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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.
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A Tour of FDA Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
A Tour of Health Canada Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
A Tour of Health Europe Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Aspects of Regulatory History Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Awareness of FDA Inspections for Pharmaceutical Ma Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Bioresearch Monitoring Program (BIMO): Introductio Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Biotechnology: An Overview of Compliance Considera Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Change Control Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Clinical Trial Audits and Consequences of Non-Comp Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Computerized Systems Inspections in the Medical De Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Drug Safety & Adverse Event Reporting Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Ethical Review Boards Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Ethics as the Foundation to Clinical Research Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
European Union Clinical Trials Directive Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
GMP Principals of SOPs Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
GMP Updates - Enforcement Changes at the New FDA Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
GMPs for API Bulk Manufacturers Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Good Clinical Practices (GCPs) for New Product Inv Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Good Laboratory Practices (GLPs) Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
GxPs Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
HIPAA - The Impact on Clinical Research Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Introduction to GMPs Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Investigational Product Development Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
ISO 14155: Obligations of Sponsors and Monitors fo Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Key Concepts of Process Validation Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Laboratory Specimens for Clinical Research Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Orientation to GMP Compliance Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Overview of the Clinical Research Process Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Part 11: Electronic Records and Signatures - Appli Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Part 11: Electronic Records: Electronic Signatures Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Principles of Good Documentation Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Protection of Human Subjects in Clinical Trials Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Selecting and Managing Clinical Contract Research Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
The Clinical Development Process: Investigational Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
Understanding Post-Approval Changes Standard Tuesday, Jun 1 2010 7:00AM - Thursday, Dec 31 2015 8:00AM
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Minimum System Requirements: Processor: Pentium 2; 300 MHz
RAM: 128 MB RAM
Browser: Internet Explorer version 4.0 or higher, or Netscape version 7.0
Modem: 28.8K (minimum); 56K (recommended)
Participants should feel comfortable operating a computer using the Windows operating system, and navigating within a web browser
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