Date and Time
Wednesday, 08th March 2023, 09:00 a.m. – 05:00 p.m.
BioM Biotech Cluster Development GmbH, Am Klopferspitz 19 a (IZB West II, Conference room 3rd floor), 82152 Martinsried
The protection of the individual in biomedical research was mandatory in Germany as early as 1900 in a Prussian decree and even renewed in 1931 - despite this, the crimes against humanity in the Third Reich took place. After the Nuremberg Medical Code in 1947, it took until the Declaration of Helsinki by the World Medical Association in 1964 to reach international acceptance. In the 1970s, the FDA identified data falsification in the context of drug trials - a new dimension of risk became apparent: market approval on the basis of falsified data endangered not only individual trial participants, but society as a whole. In the context of clinical research, it is therefore important to ensure the quality of trial results in addition to the protection of trial participants. These are the goals of GCP.
The course highlights the requirements and measures that support the GCP goals. The responsibilities of ethics committees, investigators, and sponsors are presented. There are research projects that do not deviate significantly from normal medical practice and therefore are of lower risk than others, e.g., the first use of a new drug in humans. The risk-based approach to clinical trial quality management is essential to achieve the highest possible quality with available resources. Techniques for risk assessment and risk management are demonstrated.
What is not documented, has not happened. This sentence is often quoted and well known, yet the vast majority of problems in research projects lie in the reconstruction of the course of events due to lack of documentation. How to document correctly, and which documents are essential? To answer these questions, a risk assessment is necessary as well.
After the course, participants will have extensive knowledge of GCP and know what is behind risk-based quality management of clinical drug trials. This course is suitable for both GCP beginners and GCP professionals who would like (or need) to refresh their knowledge.
According to the requirements of ethics committees (EC), individuals involved in clinical trials with medicinal products (or medical devices) should demonstrate regular participation in a certified GCP course including an update on the legal situation. This course mainly covers GCP, and, although an outlook on the new legal situation is also included, due to the massive changes, the new EU Clinical Trial Regulation 536/2014 is offered in a separate course.
You will receive a certificate of attendance as proof of qualification, e.g., for audits/ inspections or for presentation to ethics committees.
This course is designed for individuals involved in clinical trials with drugs from biotech companies, pharmaceutical companies and CROs, e.g. CRA/monitor/project leader, project management, data management, quality assurance and study teams. Members of the study team of investigator sites (e.g. study nurses, study coordinators), can also register (specific GCP investigator courses are given for investigators - program on request).
Dr. Dagmar Chase
After studying computer science (with a minor in theoretical medicine), Dagmar Chase initially worked in the computer industry. In 1983, she founded the contract research organization GMI with the biometrician Professor Albrecht Neiß and soon developed the company into a "full service CRO". The work on the company's quality management system as well as the development of many training programs for the drug development industry are - in addition to the management of GMI - among the focal points of Dagmar Chase's work. After receiving her doctorate from the Medical Faculty in Ulm in 1995 and the sale of GMI in 1997 to the American CRO Kendle (now Syneos Health), Dagmar Chase served for many years as Vice-President and Project Director for international development programs at Kendle. In 2004, she founded Clinrex, a clinical trial quality management consulting firm. In addition to training and audits, her responsibilities include gap analysis of GCP SOP systems.
Ms. Chase co-founded the Bundesverband Medizinischer Auftragsinstitute (BVMA e.V.) in 1991 and served as the association's president from 2001 until the end of 2017. In 2005, the corresponding European association was launched under her participation (EU CRO Federation, EUCROF), which she has actively accompanied since its foundation.
In 2019, Dagmar Chase was appointed Senior Expert by the German Pharmaceutical Industry Association (BPI e.V.).
You can either register once without registration by selecting the ticket and going to "confirm",
or register first in our new system, the BioM Community Network. With your login you can then register faster and easier for further events, but also post job advertisements and press releases and much more.
Further information on the course program and registration for this in-person event can be found in our agenda.
Participation fee: Euro 520,00 (+ VAT).
Melanie Greitl, firstname.lastname@example.org