FDA`s Medical Device Clinical Trials Program 2017 is a webinar that covers topics such as:
- Valid scientific evidence
- Introduction
- Significant/non-significant risk
- Phases of device human studies
- Exemption from IDE rules
- IDE meaning, content, review
- QSR design control integration
- Labeling/charging for product
- Post marketing studies product. Such knowledge might be
- Expanded access
- Understanding of limitations, evidence of clinical usefulness, or
- Required to enable the development of user instructions, better
- Why should you Attend:
- Elements of product design that require additional changes
- Clinical trials regulations (published 25 years ago), many
- In spite of the long experience device companies have with
- Only thing more expensive than a good clinical trial is a bad
- Companies have found this area an expensive trap. In fact, the
- The thought and experience that goes into a trial design. The
- Clinical trial. The probability of a successful trial is a function of
- By outside consultancies, such as CROs, but the experience has
- Thought, organization, compliance and analysis can be assisted
- Works, what its limitations are, what the company wants it to
- To be internal, a deep knowledge of the particular device, how it
- Areas Covered in the Session:
- Do, and the likelihood of its performing as desired
- Valid scientific evidence
- Introduction
- Significant/non-significant risk
- Phases of device human studies
- Exemption from IDE rules
- IDE meaning, content, review
- QSR design control integration
- Labeling/charging for product
- Post marketing studies
- Expanded access
- R&D and Regulatory Staff
- Who Will Benefit:
- Speaker Profile:
- Management of R&D Regulatory
- Law firm, Longwell and Associates, which specializes in Food
- Anna Longwell is currently principal attorney of the Palo Alto
- Regulation and law, affecting the development and ultimate
- And Drug law. The firm has expertise in US FDA expectations
- Biologics
- Marketing of new medical products, drugs, devices and
- Compliance4All DBA NetZealous
- Contact Detail:
- Email: support@compliance4All.com
- Phone: +1-800-447-9407
- Event Link : http://bit.ly/2aWhBD3
- Http://www.compliance4all.com/
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FDA`s Medical Device Clinical Trials Program 2017 is intended for:
- Management of R&D Regulatory
- R&D and Regulatory Staff
