FDA During New (Drug) Development 2018

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

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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WHEN AND WHERE

07 September 2018
United States of America

ORGANIZER

Netzealous LLC DBA - Compliance4All

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Added 5 years ago by Compliance4All on Biotechnology