AHI Webinar - "Question-Based Review - Part I: Drug Substance"
Dates:
March 4, 2010 (Overview of QbR format and QOS for Drug Substance)
March 18, 2010 (Q&A and Breakout Sessions)
Time:
Webinars will begin at 1:00pm EST both dates and run approximately 2-3 hours.
Cost:
Free
Summary:
Question-Based Review (QbR) provides a general framework for a science- and risk-based assessment of product quality in the chemistry, manufacturing and controls (CMC) submission. The QbR format is a series of questions, focusing on critical pharmaceutical quality attributes, and follows the ICH Common Technical Document (CTD) Quality Overall Summary (QOS). It is an important tool to make the submission preparation and review process more efficient. QbR was first developed in 2005 by the Office of Generic Drugs in the Center for Drug Evaluation and Research and the Center for Veterinary Medicine (CVM) has adapted the QbR concept for animal drugs.
This workshop is the first of a three-part webinar series discussing an approach to QbR for animal drugs. Part I focuses on drug substance, while Parts II and III will cover drug product and sterile process validation. Part I is divided into a two-day webinar. The first day will provide an overview of QbR format and the QOS for drug substance. The second day will give attendees the opportunity to have questions answered and to participate in mock exercises during breakout sessions.
Who Should Attend:
Regulatory Affairs Professionals
CMC Professionals
Master File Holders
Drug Product Sponsors
Materials and connection information will be e-mailed to all registrants prior to the first webinar date. The registration cut-off date is February 26, 2010.
Question-Based Review (QbR) provides a general framework for a science- and risk-based assessment of product quality in the chemistry, manufacturing and controls (CMC) submission. The QbR format is a series of questions, focusing on critical pharmaceutical quality attributes, and follows the ICH Common Technical Document (CTD) Quality Overall Summary (QOS). It is an important tool to make the submission preparation and review process more efficient. QbR was first developed in 2005 by the Office of Generic Drugs in the Center for Drug Evaluation and Research and the Center for Veterinary Medicine (CVM) has adapted the QbR concept for animal drugs.
This workshop is the first of a three-part webinar series discussing an approach to QbR for animal drugs. Part I focuses on drug substance, while Parts II and III will cover drug product and sterile process validation. Part I is divided into a two-day webinar. The first day will provide an overview of QbR format and the QOS for drug substance. The second day will give attendees the opportunity to have questions answered and to participate in mock exercises during breakout sessions.
Who Should Attend:
Regulatory Affairs Professionals
CMC Professionals
Master File Holders
Drug Product Sponsors
Materials and connection information will be e-mailed to all registrants prior to the first webinar date. The registration cut-off date is February 26, 2010.
Register Online (Please read all instructions before beginning to register.)
If you are registering multiple people from your company for the first time, please contact Patrick Krieger at (202) 637-2440. Please register each person individually, even if you plan on calling in as a group.
If you are registering multiple people from your company for the first time, please contact Patrick Krieger at (202) 637-2440. Please register each person individually, even if you plan on calling in as a group.
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Questions: