Miniserie: Einblicke und Einstiegsmöglichkeiten in die pharmazeutische Industrie
Referent: Dr. Felix Kern | online | Sprache: Deutsch
Teil 1: Regulatorische Grundlagen, Mittwoch, 17.01.2024 (17:00 – 18:00)
Teil 2: Qualitätskontrolle, Mittwoch, 24.01.2024 (17:00 – 18:00)
Teil 3: Pharmazeutische Produktion, Montag, 29.01.2024 (17:00 – 18:00)
Teil 4: Quality Assurance, Mittwoch, 06.02.2024 (17:00 – 18:00)
Teil 5: Audits, Mittwoch, 14.02.2024 (17:00 – 18:00)
GLP, GMP and quality control with Prof. Dr. Mona Tawab
1 March 2024 | 9:00 – 17:00 | in person workshop
This course will give a comprehensive overview on the concept of quality assurance in the framework of the pharmaceutical industry, including fundamental aspects and tools applied in practice, with an emphasis on GMP. Modern approaches of risk assessment will be addressed just as the implementation of CAPAs (corrective and preventive actions), dealing with OOS (out of specification) results and realizing change control in a fixed process. Also data integrity is an important issue of the course. Practical units at the end of the course will give participants the chance to practically implement the knowledge acquired on the example of case studies.
In details the course will deal with the:
- need for and origin of quality assurance
- concept and definition of quality
- regulatory key players and requirements
- applied quality standards on the example of GMP
- main pillars of a quality assurance system
- modern tools in quality assurance (risk analysis, CAPA, change control, OOS….)
Einführung in klinische Prüfungen und die „Gute Klinische Praxis“
8.3.2024, 9:00 – 16:00 | online via Zoom | Deutsch
Klinische Prüfungen finden in einem hochregulierten Umfeld statt. Die „Good Clinical Practice (ICH-E6 GCP)“ spielt als internationale Leitlinie eine zentrale Rolle und liegt allen klinischen Prüfungen zugrunde. Neben der ICH-GCP definieren weitere internationale und nationale Regelwerke (z. B. Deklaration von Helsinki, EU-Regularien, AMG) die Rahmenbedingungen klinischer Prüfungen. Dieser Kurs soll einen Überblick über die relevanten Regularien sowie weitere Aspekte (Studientypen, Studienphasen, Studiendesign, Studiendokumente) klinischer Prüfungen geben. Die Funktion und Bedeutung des klinischen Monitorings wird erläutert und Tätigkeitsfelder im Bereich klinischer Studien beschrieben.
PhD School "Inflammation and Lipid Signaling in Disease Pathogenesis"
25.-28.3.2024
The GRADE Center BioMed FIRST together with the GRK 2336 AVE and the International School of Pharmacology Giampaolo Velo offers the course "Inflammation and Lipid Signaling in Disease Pathogenesis" (Course directors: Pietro Minuz, Paola Patrignani, Bernhard Brüne, Angelo Sala, Dieter Steinhilber) which is co-funded by the ETTORE MAJORANA FOUNDATION AND CENTRE FOR SCIENTIFIC CULTURE.
The focus of this course is inflammation, lipid signaling, and the molecular mechanisms underlying various diseases like cancer and heart failure.
High-quality speakers offer young researchers in these advanced topics an updated overview of the recent results of epidemiological, clinical, and pharmacological research. In the tradition of the School, young researchers are encouraged to actively participate in discussions and present their scientific work results during the poster session or with short oral communications.
The course will be held from March 25 to March 28 in Erice, Italy. The foundation will cover costs for accommodation and meals for the speakers, traveling costs have to be covered by the participants. The registration fee for the PhD students will be 450 €, which covers the accommodation and meals.
Please contact Dr. Brigitte Held (held@grade.uni-frankfurt.de) for more information, if you wish to participate.
Workshop: Graphical Abstract
2. June 2024 | 9:00 – 17:00 | in person | with Dr. Jean-Simon Fortin
Excursion to Merck, Darmstadt
17.10.2024 | Registration deadline: 22.9.2024
(details to follow)
Excursion to Merck, Darmstadt
17.10.2024 | Registration deadline: 22.9.2024
(details to follow)
