2-day In-person Seminar on Biosimilars
Course "2-day In-person Seminar on Biosimilars" has been preapproved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Date & Time: May 10th and May 11th 2012
8 am to 5 pm PDT
Duration: 2 Days
Instructor: Steven S Kuwahara
Location: San Francisco, Marriott Marquis Downtown
Price : $1495.00
Instructor Profile: Steven S Kuwahara Founder & Principal, GXP Biotechnology, LLC
(for one participant)
Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production. ...more
Overview: This course will present the regulations and guidelines that apply to the development and production of biosimilars. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as the work on a product proceeds, starting with the early development process. The course will present the guidance documents and the related regulations while describing the activities that will be required to meet the conditions under which a biosimilar may be manufactured and licensed.
Areas Covered in the Session: Day 1, May 10, 2012 Lecture 1: Biologics in general and what makes them so different l
Suggest a Topic
Definitions and manufacturing considerations
Your Necessity is our Priority
Lecture 2: Introduction and Terminology of Biosimilars l
What are biosimilars and what about all of the terms that relate to them?
Lecture 3: Considerations for demonstrating biosimilarity I l
Structural and functional analysis
Lecture 4: Considerations for demonstrating biosimilarity II l l
Human Clinical Studies Post marketing studies and discussions with FDA
Day 2, May 11, 2012 Lecture 5: Quality Factors in demonstrating biosimilarity I l l
Culturing and Manufacturing Physicochemical factors
Lecture 6: Quality Factors in demonstrating biosimilarity II l
Reference substance comparibility
Stability Studies and characteristics of the finished drug product
Lecture 7: Regulatory Matters I l l
Biosimilarity and Interchangability Pediatric provisions under the pediatric rule and the biosimilars rules
Lecture 8: Regulatory Matters II
Submission of a Biologics License Application (BLA) ยก What is a BLA like?
Exclusivity: Innovator (Reference) Drug and the biosimilars ยก What about orphan designations?
Click here to register for this seminar Who Will Benefit: l l l l l l
Directors Managers Supervisors and lead workers in Manufacturing Process Development Regulatory Affairs Quality Assurance and Quality Control
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