CACO Pharmaceutical & BioScience Society, Monday, June 13, 2011
Topic: “CMC Strategies for Robust Product Development & NDA submissions”
Speakers: Ram Nyshadham, Raj Suryanarayan, Vijay Sabesan, David Shields, Sri Mudumba
Date and Time: Monday, June 13, 2011, 8:45 am – 5:30 pm
Location: Bay Area: Foster City Crowne Plaza
Online registration: http://www.caco-pbs.org
Workshop Outline:
This course provides an overview of CMC activities and best-practices from pre-IND work to NDA submission and beyond. It covers the roles, responsibilities and interactions between various disciplines, including drug substance and product manufacturing process development and validation, analytical method development and validation, formulation development and screening, and quality systems and interactions. This course will cover the strategy and critical studies needed for IND and NDA submissions with a heavy emphasis on clinical phase-dependent approaches and studies leading to drug approval.
This course will benefit scientists working in the pharmaceutical industry who want to improve their understanding of the CMC process from early development candidate to clinical manufacture. This course is also useful for non-pharma scientists who seek better technical understanding of the process and regulatory requirements and challenges.
