(478a) IQ Consortia and Pre-Competitive Information Exchange

The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) is a not-for-profit organization of pharmaceutical and biotechnology companies with a mission of advancing scientifically-driven standards and regulations for pharmaceutical and biotechnology products worldwide. The Active Pharmaceutical Leadership Group (API-LG) and affiliate groups are focused on advancing science-based phase appropriate strategies in the industry to create efficient and sustainable processes to deliver high quality API in alignment with Quality-by-Design principles and in compliance with regulatory guidelines and good manufacturing principles.

The API leadership group consists of members from approximately forty pharmaceutical and biotechnology companies, and they coordinate and oversees the activities of the topically focused working groups. This group is responsible for ensuring representatives from member companies represent the activity at the working group to their individual organizations.

The working groups typically consists of interested scientist from the member companies, and regularly meets to drive innovation and quality through the sharing of non-competitive best practices. Information is shared with the industry by publication, presentation or collaboration to peers, agencies or other key stakeholders. These communications typically contain case studies, survey standard approaches or practices within the industry, or provide interpretation of various regulatory guidelines.