Albany Molecular Research Inc.

Outsourcing of all phases of pharmaceutical/biological development and manufacturing continues to rise. As drug development pipelines shift toward those requiring more complex and specialized capabilities, quality agreements and communication planning to avoid non-compliance and the costly ramifications are becoming more important. This webcast will review the FDA draft guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements and provide insights from the contract manufacturing organization (CMO) perspective into the integrated responsibilities and relationship of the contract provider and the drug sponsor.

Listen to our free, on-demand webinar, “Trends in Quality Agreements & Communications: A CMO Perspective”, which was held on Tuesday, June 23, 2015 at 11 a.m. ET. The presentation was given by Milton Boyer, AMRI’s Senior Vice President of Drug Product Manufacturing.

Key Learning Objectives:

• Review FDA’s draft guidance document on Contract Manufacturing Arrangements for Drugs: Quality Agreements and the key takeaways about the high cost of non-compliance and lack of quality agreements.
   

• Understand how heightened enforcement actions changing the traditional relationship between the CMO and drug sponsor.
   

• Learn how strong CMO partners can help their pharmaceutical/biotechnology partners avoid delays to market, specifically for drug development pipelines requiring more complex and specialized CMO capabilities (e.g., biologics, biosimilars, cytotoxics). 
   

Contact Details:

Albany Molecular Research Inc.Email:clientservice@amriglobal.comWeb Address: Click here to register to watch our free, on-demand webinar