SOURCE: Conformia

February 21, 2008 09:12 ET

Conformia Hosts FDA Global Summit on Quality by Design

Event Brings Global Regulators and Senior Executives From 13 Top Pharmaceutical Companies Together for the First Time; Discussing Experiences, Challenges and Opportunities Implementing Concepts of ICH Q8, Q9 and Q10

WASHINGTON, DC--(Marketwire - February 21, 2008) - Conformia, the market leader and innovator of enterprise solutions for product/process lifecycle management (PPLM) for regulated process manufacturing industries, today announced the first U.S. Food & Drug Administration (FDA)-Conformia-PhRMA Industry Progress Summit on Pharmaceutical Development and Risk Management, taking place February 20 and 21 at the Reston Hyatt Regency in Reston, Virginia. The Summit brings together cross-functional senior executives in pharmaceutical organizations for the first time, along with the FDA, PMDA and PhRMA.

Committed to creating an advanced drug development model that improves the quality of pharmaceutical drugs, participating companies are presenting and reviewing a new case study prepared by the chemistry manufacturing and control-information management (CMC-IM) working group, which is based on a mock small molecule drug called "ACE." The case study is not designed to be prescriptive, but rather is an example of how companies could approach the implementation of several key concepts of Quality by Design (QbD) outlined in industry guidelines International Conference on Harmonization (ICH) Q8, Q9 and Q10, which cover pharmaceutical development and quality risk management.

"This is a landmark event for the pharmaceutical industry, with companies working together in harmony with the FDA and industry regulators from the U.S. and Japan," said Anjali Kataria, co-founder and CMO of Conformia. "New guidelines addressing drug development and risk assessment represent some of the most significant operational changes the industry has created in the past 20 years. The Summit is the first time cross-functional teams of senior leadership from 13 leading companies, who oversee the drug development lifecycle, are having an open dialogue about the challenges the new ICH guidelines present. Together the companies are sharing their experiences of attempting various levels of implementation and creating best practices for successfully implementing them into their businesses."

Conformia has an FDA Cooperative Research and Development Agreement (CRADA), and has been focusing efforts to help the industry meet the goals of the FDA's QbD initiative. During the Industry Progress Summit sessions, executives from leading companies, including Abbot, Amgen, AstraZeneca, BMS, Eli Lilly and Company, GlaxoSmithKline, MedImmune, Merck & Co., Pfizer, Schering Plough, Sanofi Aventis Inc. and Wyeth, will have cross-functional industry-agency discussion to key concepts related to ICH Q8, Q9 and Q10, as they to the overall QbD paradigm for pharmaceutical development submissions.

As previous FDA-Conformia-PhRMA workshops, this Summit was designed for teams of pharmaceutical industry's cross-functional senior leadership, including representatives from development, quality, regulatory, IT and commercial operations, to actively engage in a discussion with the FDA and case studies that demonstrate how to effectively meet these guidelines. Conformia has no commercial interest in this Summit. This is a not-for profit activity and if any proceeds exist post the Summit, they will be donated to charity or used for future FDA-Conformia-PhRMA workshops.

About Conformia

Conformia Software provides product/process lifecycle management (PPLM) software solutions to regulated process industries including life sciences and beverage alcohol. These solutions enable companies in highly regulated industries to save significant time and money through major improvements in product/process development operations. Conformia's web-based enterprise software helps improve product quality and integrity, reduce development and production lifecycles, enhance operational visibility and traceability, and decrease the costs and ramifications associated with non-compliance with global regulatory agencies. The market leader and innovator in providing enterprise software solutions for development operations in the pharmaceutical industry and beverage alcohol production in the consumer products and goods sector, Conformia offers an SAP-endorsed business solution for pharmaceutical development operations and beverage alcohol operations. Together SAP and Conformia are building a bridge to support the product/process lifecycle from development to manufacturing. For more information, go to

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