Moderator: Peggy Wright, Editor of Transdermal
Presenter: Michael Gross, PhD, RAC
Michael Gross is a senior consultant, specializing in combination products, at the Biologics Consulting Group. Gross received a PhD in organic chemistry from Temple University and did post-doctoral studies in biochemistry at the National Institutes of Health. He possesses 30+ years of experience in medical-product development, registration, and compliance, including as an FDA biologics CMC reviewer and inspector and in senior positions (director and vice-president of regulatory affairs, vice-president for compliance) for large and small pharmaceutical and biotech companies and a large medical-device company.
CDs are non-returnable/non-refundable
Transdermal is the only technical publication devoted exclusively to readers involved in development and production of pharmaceuticals delivered through the skin.
Webinars
FDA Regulation of Transdermal Drug Delivery Technologies, 10/11
CD of live broadcast 10/18/11
This webinar considers how the FDA regulates investigational and marketed transdermal drug delivery technologies for two drug development and regulatory pathways: (1) drug products and (2) combination products (combined drugs and devices). Michael Gross presents general principles and recommendations on development, registration, and compliance for transdermal drug delivery systems. He covers product jurisdiction, investigational exemptions, marketing applications, clinical investigations, labeling, quality systems, and safety reporting for a number of transdermal drug delivery technologies, including osmotic patches, iontophoresis, and microneedles. Michael was a participant at the DIA-FDA meeting entitled, "Improved Development and Regulation of Transdermal Systems" in Arlington, Virginia on September 15 and 16, 2011. As part of this webinar he will discuss key take-home messages from this meeting.
This webinar considers how the FDA regulates investigational and marketed transdermal drug delivery technologies for two drug development and regulatory pathways: (1) drug products and (2) combination products (combined drugs and devices). Michael Gross presents general principles and recommendations on development, registration, and compliance for transdermal drug delivery systems. He covers product jurisdiction, investigational exemptions, marketing applications, clinical investigations, labeling, quality systems, and safety reporting for a number of transdermal drug delivery technologies, including osmotic patches, iontophoresis, and microneedles. Michael was a participant at the DIA-FDA meeting entitled, "Improved Development and Regulation of Transdermal Systems" in Arlington, Virginia on September 15 and 16, 2011. As part of this webinar he will discuss key take-home messages from this meeting.
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