ISPE, PIC/S To Co-Sponsor Interactive Workshop

ISPE has announced it will collaborate with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to co-host an interactive Workshop for the industry and its regulators.

“Systems Approach to Quality Risk Management” will be held 22-23 November 2007 at the Grand Copthorne Waterfront Hotel in Singapore.

This is the first time that PIC/S has joined with another organization to co-host a workshop and the first time that PIC/S inspectors and regulators will collaborate with industry professionals.

The two-day, hands-on Workshop is an opportunity for industry professionals and regulatory leaders from up to 40 nations to make a difference, and will offer attendees the chance to work side-by-side with regulators, with the goal of creating a better understanding and working relationship between regulators and industry.

The workshop will examine the International Conference on Harmonization (ICH) Quality Vision, provide a deeper understanding of Quality by Design (along with each separate guidance; Q8, Q9, Q10), identify the opportunities and greater affects for industry as they are implemented synergistically, plus build on that knowledge through dialogues and concept sharing with PIC/S regulators for a better understanding of the opportunities associated with Quality by Design.

The Workshop will be very practical with tangible examples and real-world applications, and a minimum of theoretical discussions, and is designed for attendees to be able to utilize and apply the topics discussed as a result of having attended.

Day one of the Workshop is designed for industry professionals. Day two is designed to provide the opportunity for industry professionals and regulators to collaborate in a series of breakout groups and round tables as well as in a group setting.

Those will be followed by the report back by group leaders, questions and answers on risk management, and summary and conclusions.

For more information, please visit www.ispe.org/pic/s