FDA During New (Drug) Development 2018
ENDED
Training by
Compliance4All
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On-Site
/ Training
USD 150.00
Details
Overview:
Why should you Attend: Provide guidance on effectively interacting with FDA throughout the new drug development process.
Areas Covered in the Session:
Who Will Benefit:
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
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.
Outline
Special Offer
One Dial-in One Attendee
Price: $150.00
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Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
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