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Webinar - FDA Meetings -Getting the Most From the Consult
Wednesday, March 10, 2021, 8:00 AM until 10:00 AM
Link will be emailed to attendees 2 days prior to the meeting, or the night prior if
registering closer to the event
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RSVP by Tuesday, March 9, 2021
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TOPIC: FDA Meetings -Getting the Most from the Consult
TOPIC DESCRIPTION: There are not that many opportunities to consult FDA. FDA meetings (Pre IND, End of Phase 1, End of Phase 2, and other meetings) take an enormous amount of planning and resources. It also takes at least 60 days to receive the FDA responses starting from submitting the meeting request. This presentation will talk about how to plan for a meeting, the timing of the meeting, the data to provide, and, most importantly, how to ask the type of questions to get the information needed to guide your CMC, Nonclinical, and Clinical development programs. After this presentation, the attendee should have an understanding of the types of questions that are appropriate to ask at each stage of development and also when to ask the "forward looking" questions that guide future planning. Getting a "yes" answer from FDA is good, but sometimes getting the "no" is equally important
SPEAKER: Clara Li
SPEAKER BIOGRAPHY: Clara Li has over twenty eight (28) years' experience in regulatory affairs with expertise in the US, European, Canadian, and Asia Pacific regions (Phases I IV). She plays a strategic regulatory leadership role in the development of well characterized biologics; small molecules; cell, tissue, and gene therapy; microbiome; vaccines; and combination products. Clara is a lead strategist with quick understanding and assessment of how to develop innovative regulatory paths leading to clinical programs and marketing approval and is an expert in integrating and leading multi disciplinary project teams to meet aggressive timelines.
Therapeutic area expertise include oncology, inflammation, immunology, cardiovascular, renal, endocrine, neurology, ophthalmology, infectious diseases, and dermatology.
Clara has planned and successfully executed FDA and EU health authority negotiations, submissions, approvals of clinical trial (IND, CTA) and marketing submissions (NDA, 505(b)2 NDA, BLA, MAA), and life cycle management of dossiers as well as made successful submissions and approvals of Orphan, Fast Track, Breakthrough, QIDP, Pediatric Plans (PIP/PSP) and PRIME.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification