European QP Association (EQPA), KisselPharmaConsulting
Katja Kotter
Vetter Pharma-Fertigung
Sigrid Guhr
formerly AbbVie
Note: All times mentioned are CET.
Zielsetzung
During this Course, specialists will share their expert knowledge about all important GMP aspects in Pharmaceutical Development and Investigational Medicinal Product (IMP) Manufacturing. You will be able to elaborate and discuss both EU and FDA requirements.
Hintergrund
Not only in the manufacturing of marketed products (c)GMP Compliance is mandatory. Also in the manufacturing of IMP supplies, compliance with the applicable GMP Guidelines is obligatory. But which GMP requirements are the applicable ones? And do the requirements differ from clinical phase 1 to phase 3? And what is the role of ICH Q8, Q9, Q10 and Q12?
With the third revision of ICH E6 (ICH E6(R3)), the GMP for IMP principles will be expanded to the following: Adequate measures to ensure that the investigational product is handled and shipped appropriately should be implemented.
Previously, the WHO already published two documents relating to Development and GMP for IMPs: „Good Practices for Research and Development Facilities of Pharmaceutical Products” and „GMP for IMPs“.
In addition, instead of the current EU GMP Annex 13 (Manufacture of IMPs), the Detailed Commission guidelines on GMP for IMPs for human use apply.
Complex challenges have to be faced and resolved to guarantee high quality products. The safety of the drug and hence also the patient should always be the main focus. Terminated studies or studies without reliable results will lead to extensive extra costs and delays in the whole development and approval process.
This course has been designed by the ECA to broaden your knowledge and to consolidate the various GMP aspects which need to be considered in a successful development of a new pharmaceutical product.
Zielgruppe
This course has been designed for R&D personnel involved in Pharmaceutical Development, IMP Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs.
Teilnehmerstimmen - das sagen andere über unsere Seminare:
„"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen. Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.” Christian Wagener, WAGENER & CO. GmbH GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023