Q&A-Medical Product Development: What's Hot/Not in the Era of the Pandemic?
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Event hosted by Ground Zero Pharmaceuticals
June 3, 2021 – June 3, 2021Online event
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The regulatory affairs and medical product development landscape has been modified by the worldwide pandemic in. terms of communications, travel, clinical trial execution and interactions with regulators in some cases. Nevertheless, the development review and approval of drugs, biological therapeutics, and vaccines has continued and the FDA, in particular, has made heroic efforts to support the industry and patients alike. This webinar will be a Q&A session that will allow all participants to ask either targeted or general questions of Dr. Evan B. Siegel leading to live dialogue. A formal presentation will not be part of this session to allow for maximum free flow of conversation. Suggested issues for discussion include:
My product is at a stage where a meeting or telecon interaction with the FDA is needed for move ahead quickly. Will I be able to schedule such a consultation in a timely fashion?
I have to submit a new protocol to my IND. Can I execute this as I used to?
I have a hot new idea for a nasal COVID therapeutics. How do
I get it into the regulatory system?
I need to submit an IND. How do I do so in the pandemic era? What about a pre-IND meeting?