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GlobalCompliancePanel, Online Training
2011-01-12
Overview: Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol. When conducting research on children, drug companies must ensure that ethical boundaries are observed in both the design and execution of pediatric trials. Attend this Webinar to understand the ethical, economic, regulatory and technical considerations when conducting clinical studies on children. Discussions evaluate the current issues in pediatric drug development and discuss approaches and best practices for overcoming these challenges. Areas Covered in the Session: - Compilation of various regulatory and guidance documents from the FDA and OHRP on the conduct of research involving children
- Recent guidances on compliance and general considerations in the conduct of research on children
- General Considerations for the Clinical Evaluation of Drugs in Infants and Children
- Discuss Clinical Investigation of Medicinal Products in the Pediatric Population
- Nonclinical Evaluation of Pediatric Drug Products
Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including: - Pediatric Affairs
- Pediatric Strategy
- Pediatrics
- Clinical Research
- Clinical Development
- Clinical Operations
- Clinical Affairs
- Medical Affairs
- Clinical Trial Management
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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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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2011-01-12
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Registration:
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Wednesday, January 12, 2011
10:00 AM PST | 01:00 PM EST | | | Live live online training only for one participant | | |
| | | | | | Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) | | |
| | | Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar) | | |
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E-mail:
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webinars@globalcompliancepanel.com
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