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.

Learning Outcomes

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).

Attendance Fees

1.100 €
1.450 €
Members of the AGAH, BAPU, Club Phase I, AHPPI, DGPharMed, DGKliPha
Non-Members 
1.900 €

2.500 €

Part I plus II  
for Members of the AGAH, BAPU, Club Phase I, AHPPI, DGPharMed, DGKliPha

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

Venue

SocraTec R&D GmbH
Im Setzling 35
61440 Oberursel

Contact and further information

Association for Applied Human Pharmacology (AGAH) e.V. 
office: Goernestraße 30
20249 Hamburg

phone: +49 170 7844438
E-Mail: info ( a t ) agah.eu
Web:   www.agah.eu

This workshop is supported by PreClinical Safety (PCS) Consultants Ltd.

Registration & Programme Download

CSi Hamburg GmbH
Conferences | Symposia | Incentives
Goernestraße 30
20249 Hamburg
Germany

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.