Senior Vice President, Documentary Standards & Compendial Policy United States Pharmacopeia
Title: This presentation will describe the evolving compendium in addressing key new paradigms for ensuring phamaceutical quality and the need for novel approaches, to developing the pharmacopeial Standards. It also provides an overview of the recent advances in the Pharmacopeial science and strategy frame work in conjunction with the current technological and regulatory trends. The evolving approaches for developing Standards taking into account the emerging modalities and regulations will be described. The presentation will also include examples of the new USP processes and strategies supporting novel manufacturing technologies, Over the Counter drugs, and emerging modalities will be discussed.
Develop a greater understanding of the need for pharmacopeial evolution due to the curerent quality paradign shifts and the goals and objectives of USP in advancing medicine quality
Prepares the generic the manufacturers for the upcoming changes in establishing USP Standards meeting the compliance requirements for product release.
Update on the collaborative efforts between CPA, FDA and USP regarding advances in developing the Standards for Over the counter drugs.
Use of the new compendial processes ensuring compliance prior to ANDA submission. Familiarize with FDA draft guidance “Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process