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Netzealous LLC DBA - Compliance4All, Online
2018-09-07
Overview:
Why is it important to engage with the FDA? - To discuss your development plan to support NDA or BLA regulatory submission
- To identify and mitigate potential issues early
- To identify any critical issues and aspects of your program such as
- Preclinical studies
- Chemistry, Manufacturing and Controls (CMC) Considerations
- Clinical Studies
- Pediatric considerations
- Statistics or regulatory considerations
Why should you Attend: Provide guidance on effectively interacting with FDA throughout the new drug development process.
Areas Covered in the Session:- Identify the major points of contact to engage with FDA's Center for Drug Evaluation and Research (CDER)
- Describe the types of formal meetings that may be held with FDA
- Understand different types of questions that may be asked during formal meetings
- Outline the information needed to support such meetings
- Explain how, when, and why to submit a meeting request and meeting package
- Describe tips for productive meetings with FDA
Who Will Benefit:- Regulatory Affairs
- Marketing Department
- Compliance Specialists
- Clinical Project Leaders
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Organized by:
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Event Manager |
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Invited Speakers:
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Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital.
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Deadline for Abstracts:
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2018-09-06
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Registration:
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https://www.compliance4all.com/control/w_product/~product_id=502109LIVE?channel=molgen_Sep_2018_SEO
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E-mail:
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support@compliance4All.com
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