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Göttingen, June 24, 2010
Advanced ICH/GCP Training Promotes Clinical Research at the UMG
Training qualifies doctors as clinical research investigators
Steadily rising standards for quality in clinical research pose new challenges. Doctors and medical specialists are compelled to gain insight into these high national and international standards and obtain the qualifications required by regulatory agencies and ethics committees.
This is where the Professional Training program of the Institut für anwendungsorientierte Forschung und klinische Studien GmbH (IFS), Göttingen, comes into play. The program caters to doctors and nursing staff engaging in clinical trials. Courses are held twice a year enabling participants to obtain, up on completion of the training, the documentation evidencing the qualifications necessary for conducting clinical studies. The IFS, Göttingen, held the fourth half-day ICH/GCP seminar on June 17, 2010, from 3 pm to 7 pm.Professor Dr. Cornelius Frömmel, Chairman of the Board of Universitätsmedizin Göttingen Medical School, and Mr. Dirk Simon, Managing Director of the IFS, opened the event hosted by Dr. Heike Hennig, Director Clinical Trial Management at the IFS.
Local lecturers PD Dr. Thomas Wobrock of Universitätsmedizin Göttingen and IFS staff Dr. Volker Hoffmann and Melanie Querfurt IFS were joined by guest speakers specializing in drug safety (Dr. Jenny Gebhardt, PhD and Head of Pharmacovigilance, BPI Service GmbH, Berlin) and investigative site inspections (Mr. Michael Rappl, a senior pharmaceutical counselor at the Bavarian government's pharmacovigilance agency).
"We were delighted with the excellent turnout with 110 people attending," notes Dirk Simon, Managing Director of the IFS. "This shows that Göttingen's reputation as a research site extends far beyond the region."
The concise one-day course allows insight into current legal, government, and administrative requirements, enabling doctors and medical specialists to earn the certifications necessary to design and conduct clinical studies.
What is GCP/ICH?
Good clinical practice (GCP) is an international ethical and scientific standard of quality for designing, recording, and reporting clinical trials.
Compliance with this standard provides assurance that the rights, safety, and wellbeing of trial subjects are protected in accordance with the Declaration of Helsinki. In addition, these standards aim to ensure data are verifiable and credible.
The Declaration of Helsinki is a statement issued by the World Medical Association to define international ethical and medical principles for conducting medical research with human subjects. Drafted in 1964 and revised repeatedly over the years, the current version dates from 2008.
The ICH-GCP guidance derived from this statement aims to provide a unified standard for the European Union, Japan, and the United States to enable mutual acceptance of clinical data by these jurisdictions' regulatory authorities, as well as to strengthen and foster clinical research.
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