The Drug Information Association (DIA) is to hold its inaugural Clinical Forum in Madrid, Spain, on 15–19 October. The event will feature conferences, workshops and training courses.
The US-headquartered body is an international association of some 18,000 professionals involved in discovering, developing, regulating, surveillance or marketing of drugs or related products
Events at the forum will touch on several areas of drug development, including clinical data management, e-clinical issues, clinical R&D, project management for clinical trials, pharmacovigilance, statistics, knowledge management, medical writing, medical information and communications, information technology and innovative medicines.
Barry Burnstead, 2007 forum chairman and director of standards at pharmaceutical services company i3 Global UK, explained: “The forum has an innovative structure that enables delegates to build their own conference. Regardless of their discipline, attendees can choose from any of the forum’s conferences, workshops, and training courses.”
This structure, along with the forum’s coverage of the clinical arena, is intended to encourage collaboration among clinical departments.
- Multi-track conference: the power of the clinical team.
- International workshop on statistical methodology in clinical R&D.
- Medical information and communications.
- Global trends in medical writing and the evolving regulatory environment.
- Leveraging knowledge management: product cross-licensing, product liability and pharmacovigilance.
- Safety data management.
- Optimising clinical trial design and management.
- Operational interfaces: from study planning to report.
- Workshop on innovative medicines (in Spanish).
- Effective project management for clinical trials.
- Drugs in pregnancy: from data to risk communication.
The clinical forum’s emphasis on e-clinical issues reflects the resurgence in the use of electronic data capture (EDC) and other technology in clinical research, Mr Burstead said.
“Despite the potential of many technologies to reduce risk to patients, many delegates will come to the forum with concerns about related regulatory compliance challenges,” he added. “The forum will explore how pharma can mitigate some of these challenges.”
The forum will feature representatives from the EMEA and national regulatory agencies throughout Europe, as well as the FDA, and a keynote address by Professor Sir Gordon Duff, chairman of the UK Commission on Human Medicines (CHM).
In 2006, Sir Gordon was appointed chairman of the UK Secretary of State’s expert scientific group on phase I clinical trials and led an enquiry into the Northwick Park Hospital TGN1412 clinical trial that left six men seriously ill. His report contained 22 recommendations to increase safety in clinical studies.