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HUM-MOLGEN
-> Events
-> Meetings and Conferences |
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November 08, 2012 |
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ComplianceOnline, Online Event
2012-12-05
Why Should You Attend: You should attend this webinar if you or your clinical investigators would want to know the answer to one or more of the following: - Does your company clearly understand the risks associated with inappropriate expanded access use of your medical device?
- Do your research sites/clinical investigators understand the requirements for Emergency Use, Treatment Use, Compassionate Use and Continued Access?
- When is FDA Approval required?
- What are your obligations under these programs?
- What are the key considerations in determining which option is most viable?
The FDA allows access to investigational devices under one of four main mechanisms by which the agency may make an unapproved device available. But there are criteria that must be met and requirements that must be fulfilled dependent upon the marketing status of the device and the timing of the need.
This webinar is designed to provide attendees with a more detailed understanding of some of the more obscure options available to providers and patients to gain access to medical devices that are not yet released to the US Market. Areas Covered in this Webinar: - Brief overview of 510(k), PMA and IDE requirements.
- Emergency Use Criteria and Regulatory Obligations.
- Treatment Use Criteria and Regulatory Obligations.
- Compassionate Use Criteria and Regulatory Obligations.
- Continued Access and Regulatory Obligations.
Who Will Benefit: - Clinical Investigators
- Regulatory Affairs Personnel
- R&D Managers
- Site Administrators
- Clinical Affairs Personnel
- Clinical Research Managers
- Clinical Project Managers
- Clinical Research Associates / Monitors
- Clinical Research Coordinators
- Quality Assurance
- Marketing Personnel
- Compliance personnel in hospitals and clinics
- Physicians
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Organized by:
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Complianceonline |
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Invited Speakers:
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Glenda Guest, is Vice President of Norwich Clinical Research Associates Ltd. (NCRA), a full service Clinical Contract Research Organization (CRO) serving the pharmaceutical, medical device, biologics and nutritional product industries since 1994. She specializes in medical device monitoring and project management, auditing and training on US regulated research, quality systems and Good Clinical Practices in clinical research settings as well as for professional organizations.
Her auditing experience includes GCP auditing, independent third party, pre-PMA audits, Japanese GCP preparation audits and includes corrective action recommendations. She provides SOP development assistance and staff training relative to correcting audit deficiencies.
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Deadline for Abstracts:
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2012-12-04
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Registration:
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E-mail:
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referral@complianceonline.com
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