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GlobalCompliancePanel, Online Training Webinar
2010-09-29
Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining ongoing compliance will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for their clinical studies. Areas Covered in the Session: - Discuss the FDA's role in Drug Development
- Principles of GCP
- Activities that are common to most trials
- Summarize FDA GCP regulations
- Recognize how GCP impacts the clinical research process
- Prepare concise documents and provide
- Necessary information for clinical studies compliance
- Maintain ongoing compliance
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Sandy Soliman: -Sandy is currently the co-founder and Chief Clinical Officer of Research Alliance LLC.; a consulting firm focused on global clinical trial solutions, tools, and training to streamline drug development to market. The firm advises clinical research sites, pharmaceutical drug development, biotech, medical device, and contract support organizations. Sandy began her journey in Clinical Research over 13 years ago. Her experience spans key aspects in multiple therapeutic areas and phases of drug development in the roles of study coordinator, site monitor, clinical research project manager, and trainer. She has effectively provided clinical research education and customized training in areas of the clinical research process, the FDA regulations, GCP (Good Clinical Practice) and the International Conference of Harmonization (ICH) guidelines. Sandy has created company-wide SOPs for a variety of relevant processes related to clinical research including, but not limited to, Informed Consent Process, Scheduling, Follow-up, Adverse Effect Reporting, etc. She has also been pivotal in coordinating, arranging, and managing the infrastructure of the company policies and procedures. She has also been awarded the National Association of Women Business Owners – NYC Chapter Phoenix Award 2008 and the National Association of Women Business Owners – NYC Chapter Golden Glove Award 2008.
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Deadline for Abstracts:
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2010-09-28
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Registration:
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| | Live live online training only for one participant | | |
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E-mail:
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webinars@GlobalCompliancePanel.com
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