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Active Pharmaceutical Ingredient (API) and Drug Product Specifications – From Clinical Development to Market Approval

 
  June 24, 2014  
     
 
Center for Professional Innovation & Education, Inc., Los Angeles, CA
Aug. 25 & 26, 2014


Specifications for active pharmaceutical ingredients (APIs) and pharmaceutical drug products, both chemical drugs and biologics, are essential for product quality and patient protection. The goals of specification setting are (1) to determine appropriate and safe limits or quantitative ranges during clinical development and (2) to justify specifications for the product to enter the market. One of the most difficult challenges in establishing and subsequently justifying specifications is achieving the appropriate balance among all factors – patient safety and efficacy, scientific data, analytical variability, process knowledge and capability, regulatory requirements, and business issues.

The approach to specification setting and their justification has undergone significant change. Strategic international ICH regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including both chemical drugs and biologics, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).

Therefore, it is most important for a pharmaceutical company to have an effective and regulatory compliant approach to setting specifications that can meet both FDA and EMA requirements and expectations. At each stage of drug development, from Phase 1 through commercialization, the basic question needs to be addressed: ‘What is absolutely necessary for the assigned specification to be successful in getting the chemical drug/biologic through clinical trials and into the market, but without impacting patient safety or creating delays in the program?’ Of equal importance is the need to justify which quality attributes do not need an assigned specification. Regulatory compliant deficiencies in assigned specifications have resulted in clinical holds and market approval delays.

This course will help the attendee to establish specifications meeting global regulatory requirements and expectations. Participants will also become effective in justification of specifications.

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers: Contact info@cfpie.com for a list of course instructors
 
Deadline for Abstracts: n/a
 
Registration:
http://www.cfpie.com/showitem.aspx?productid=011&utm_source=Hum-Molgen&utm_medium=Course%20Listing&utm_campaign=Web%20Listing%3A%20Hum-Molgen

E-mail: info@cfpie.com
 
   
 
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