AGAH-Workshop “Introductory Course in Exploratory Medicines Development – Part I”
29.11.2017 – 1.12.2017 in Oberursel
Introduction and Learning Outcomes
This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of several days provide a concise overview on Human Pharmacology / Translational Medicine spanning from non-clinical pharmacology and toxicology over first-in-man studies to proof-of-concept clinical trials.
On successful completion of Part 1, students should be able to demonstrate an understanding / knowledge of the following:
- principal steps in drug development – from compound selection to marketing application and beyond
- pertinent issues involved in the undertaking of early clinical research
- specific aspects of how to set-up and conduct early phase clinical trials
- regulation of medicines in Europe
- development and review of compound-specific information to ensure adherence to scientific, medical, ethical, and legal provisions
- integration of pertinent available scientific information into an IB and a clinical trial protocol
- principles of trial design, protocol submission and clinical conduct
- selection of appropriate trial population
- most common early phase clinical trials and their specific requirements
- assessment and evaluation of safety data from clinical trials
- relevance of formulation properties and in vitro characteristics of the trial medication for design and planning of an early phase clinical trial
- basics of pharmacokinetics
- defining pharmacokinetic (PK) endpoints for early phase clinical trials
- method validation according to good clinical (GCP) and good laboratory (GLP) practise practical aspects of bioequivalence trials
This AGAH course meets the standards for high-quality postgraduate education and training in Medicines Development established by PharmaTrain and has been awarded a PharmaTrain Recognition. The course (in 2016/17) was accredited 3 ECTS (Parts I plus II).
|Members of the AGAH, BAPU, Club Phase I, AHPPI, DGPharMed, DGKliPha|
Part I plus II
Part I plus II for Non-Members
Special fees for students are available on request
This course will be accredited by the Landesärztekammer, participants will be awarded ”Fortbildungspunkte”.
More information will be given in due time
SocraTec R&D GmbH
Im Setzling 35
Contact and further information
Association for Applied Human Pharmacology (AGAH) e.V.
office: Goernestraße 30
This workshop is supported by PreClinical Safety (PCS) Consultants Ltd.
Registration & Programme Download
CSi Hamburg GmbH
Conferences | Symposia | Incentives
phone: +49 40 30770300
fax: +49 40 30770301
e-Mail: agah-veranstaltungen ( a t ) csihamburg.de
May we please ask you to use the registration form.