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Biosimilar (Generic) Biologics In The USA: Approval Pathway - Webinar by GlobalCompliancePanel
This Webinar is over| Date | Mar 11, 2014 |
| Time | 01:00 PM EDT |
| Cost | $195.00 |
|
Online
|
Overview:
This web presentation presents an overview of FDA's requirements for approval/marketing of a Biosimilar (Generic Biologic) product. The webinar covers the Biosimilar product testing requirements (clinical and nonclinical) and the Biosimilar approval pathway.
The webinar also reviews the Regulatory/Scientific/Quality principles involved along with the 3 FDA Biosimilar guideline documents. In addition, the FDA Stepwise Approach and the FDA Totality of the Evidence concepts will be discuss.
Why should you attend:
This web presentation is intended for those professionals that require knowledge about FDA's three major regulations GCP, GLP and GMP.
Albert A. Ghignone MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical.
Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
This web presentation presents an overview of FDA's requirements for approval/marketing of a Biosimilar (Generic Biologic) product. The webinar covers the Biosimilar product testing requirements (clinical and nonclinical) and the Biosimilar approval pathway.
The webinar also reviews the Regulatory/Scientific/Quality principles involved along with the 3 FDA Biosimilar guideline documents. In addition, the FDA Stepwise Approach and the FDA Totality of the Evidence concepts will be discuss.
Why should you attend:
This web presentation is intended for those professionals that require knowledge about FDA's three major regulations GCP, GLP and GMP.
- Regulatory Affairs Personnel
- Quality Personnel
- Research Personnel
- Clinical Personnel
- Legal Personnel
- Manufacturing Personnel
- Auditors
- Clinical Research Associates (Monitors)
- BPCI Act
- Define the terms Biosimilar and Interchangeability
- FDA's Stepwise Approach
- FDA's Totality-of-the - Evidence Approach
- The Biosimilar Approval pathway
- Regulatory Affairs Personnel
- Quality Personnel
- Clinical Personnel
- Research Personnel
- Manufacturing Personnel
- Legal Personnel
- Personnel who require an understanding of the FDA Biosimilar process
Albert A. Ghignone MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical.
Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
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