DIA Tweaks Final Program

February 1, 2010

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-02-01-2010, Volume 0, Issue 0

A look at what the 46th Annual EuroMeeting has in store for attendees.

As the Drug Information Association's (DIA) much anticipated EuroMeeting starts to loom large on the congress calendar, the organizers have made some significant late additions to the hot topics covered in the scientific program, including a new session about missing data.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is introducing new requirements for missing data, and the final version should be available when the session takes place in Monaco at 4:30 pm, Monday March 8. Speakers will discuss the key regulatory changes, the use of graphic methods to help understand missing data patterns, and the trials and tribulations of missing data.

The Grimaldi Forum opened in 2000, built on land reclaimed from the sea. (PHOTO: DIA)

Also, the organizers have added a session about implementation of ICH Q8, Q9, and Q10 (Quality by Design), which still has many unclear aspects for industry and regulators. Presenters will address analytical methods, knowledge management, and control strategy/batch release strategy. A third extra session will concentrate on the new variations system for marketing authorizations. It will look at how the system will affect the management of quality-related changes in the future and the implication of these changes for industry and regulators.

Finally, submitting a quality dossier and e-submission will be covered in another late additional session. Speakers will give specific guidance on avoiding pitfalls in the electronic Common Technical Document.

The opening plenary session will be structured as an "Oxford Debate," following the University of Oxford's eminent tradition. The provisional title of the motion for debate is: "The process to develop new medicines and bring them to patients is neither efficient nor effective. There is a risk that medical needs will no longer be fulfilled in the future if the relevant stakeholders are not included in the process."

The DIA is on target to reach 3000 participants and over 230 exhibition booths, according to Senior Event Manager Dermot Ryan. He advises delegates to keep an eye on DIA's Web site (www.diahome.org) for details about the plenary lectures, and urges them to view the final program online.

One of the major changes for this year's event is the series of measures designed to reduce the environmental impact of the conference.

"The Grimaldi Forum has virtually zero emissions of greenhouse gases," Ryan noted. "The infrastructure is already in place at the Grimaldi Forum in areas such as the use of a seawater pumping system to provide energy for the air-conditioning system, which reduces energy requirements by 20% to 30%, low energy lighting throughout the building, and sensitive modern taps for water, hand-dryers, and an eco-efficient flushing system for the toilets."—Philip Ward

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