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global compliance panel, United States
2011-09-20
Areas Covered in the Session:- Preparing for study close-out visit from various perspectives (e.g., DM, PM, CRC, CRA perspectives)
- Managing study close-out visit
- Sponsor's Responsibilities
- Disposition of supply of investigational products
- Assurance of IRB review
- Investigator recordkeeping & archiving/record retention
- Inspection of investigator's records & reports
- Quality Assurance Responsibilities
- Data Review Meetings
- Proactive Vendor Management
- Financial/Accounting Reconciliations
- Regulatory Obligations (Sponsor & Site)
Who Will Benefit:- CRAs
- CRCs
- Nurses
- Clinical Trials Associates
- Regulatory Affairs
- Clinical Team Managers
- Clinical Trials Project Managers
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Organized by:
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global compliance panel |
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Invited Speakers:
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Fatuga is a social-entrepreneur who is actively engaged in three primary roles/companies: (a) founder/president of Caligeo Clinical OneVision; (b) founder/CEO of Caligeo Clinical CRO; and (c) founder/Executive Director of Atlanta Premier SMO. His professional passion lies in promoting clinical trial opportunities in emerging markets (especially in Africa, the Caribbean, East Asia, and Latin America) and among under-represented population (in the USA). He recently completed his MBA degree from Emory University/Goizueta Business School with a focus on Entrepreneurial ship/Organizational Behavior & Management. He received his M.Sc. in Drug Regulatory Affairs and Health Policies from Massachusetts College of Pharmacy and Health Sciences and BS degree in Neuroscience from Brown University. He has more than 15 years of experience in the clinical research industry. Fatuga began his clinical research career as a study coordinator at Brown University. Since then, he has had leadership opportunities as Clinical Team Manager, Project Lead, QA/QC Manager, Lead CRA, CRA Consultant, Medical Research Associate, and CRA Specialist in a variety of companies such as central imaging facility, Contract Research Organizations (CROs), biotechnology and pharmaceutical companies. Fatuga is currently certified as a Project Management Professional (PMP) and a Clinical Research Associate (CCRA). He is an active member of the International GCP Training Advisory Board for the Association of Good Clinical Practices in Nigeria (AGCPN) and also a member of Nigerian Association of Pharmacist and Pharmaceutical Scientists in the Americas (NAPPSA). Fatuga is also a member of the International Committee/Leadership Team of the National Biotechnology and Pharmaceutical Association (NBPA) which is a US based organization functioning in collaborative efforts to discuss challenges and opportunities of conducting clinical trials with diverse communities as well as addressing the disparity issues in the clinical trial industry. |
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Deadline for Abstracts:
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2011-09-20
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Registration:
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Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00
webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
Phone: 800-447-9407 Fax: 302-288-6884
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E-mail:
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webinars@globalcompliancepanel.com
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