Seminar - Virtual
The successful filing of an Investigational New Drug application (IND) is a pivotal milestone for an emerging pharma company. This webinar is designed to address this crucial topic for the key industry segment. Citing the FDA website for an IND application, “Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.” This webinar is geared towards smaller pharma companies filing an IND for the first time but even experienced drug developers could benefit from an overview of the requirements and considerations. The goal is to educate and enable our listeners in pursuit of this key objective. While this particular talk is geared towards small molecule active pharmaceutical ingredients (API) and drug products, much of it applies to biologic products as well. The webinar features three prominent experts in the pharmaceutical development arena and each will highlight a different facet of the IND process.
Organization: Regis Technologies, Inc. (firstname.lastname@example.org)
For more information: http://xtalks.com/IND-
December 4, 2015 (11:00am EST-12:00pm EST)
Contact: Kristine Biederer (email@example.com)