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Safety Pharmacology Course 2018 in Basel

Basel Cathedral

Safety Pharmacology Course 2018

Part of DGPT Modular Training Programme in Toxicology
February 5th to 9th, 2018
Lecture Hall of the Pharmacy History Museum of Basel
Totengaesslein 3, CH-4051 Basel, Switzerland


Safety Pharmacology studies address adverse drug reactions of new chemical entities (NCEs) and biotechnology-derived products in the drug development process. Whereas classical toxicological investigations address clinical and morphological changes after single and repeated dose studies, Safety Pharmacology studies investigate the potential undesirable pharmacodymamic effects on physiological functions (cardiovascular, CNS, respiratory) in relation to exposure, commonly after single dose.

Safety Pharmacology is a relatively young discipline in drug safety sciences and has its roots in general pharmacology that was part of routine development programmes. Release of guidelines by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH, www.ich.org) emphasized the importance to ensure a harmonized evaluation of new drug candidates before humans are exposed in early clinical studies.

This course provides a broad overview on the organ systems of interest as well as standard tests to investigate drug effects on these systems. Each organ system will be introduced before detailed information on the safety pharmacology aspects is provided. Integration of Safety Pharmacology findings in an overall risk assessment will be demonstrated. Concordance data and case reports will provide the evidence how meaningful pre-clinical data are for the clinical situation.

Lab tours will provide insight into the daily routine and demonstrate some key models for the safety pharmacology assessment of drug candidates.

At the end of this one-week course participants will have gained a clear understanding of the various tests used and the role of Safety Pharmacology in the drug development process.

Course Topics

  • Introduction to Safety Pharmacology
  • Cardiovascular basics, in vivo and in vitro models and endpoints. Evaluation of ECGs and introduction into cardiac arrhythmias
  • CNS basics, core battery and supplemental studies
  • Anatomy and physiology of respiration, tests on respiration
  • Renal function and tests
  • Gastrointestinal function and tests
  • Biotechnology-derived and oncology drugs
  • Integration of Safety Pharmacology endpoints in toxicology studies
  • Thorough QT Studies
  • Chronopharmacology
  • Case studies
  • Integrated risk assessment
  • Regulatory background, guidelines and Good-Laboratory-Practice (GLP)
  • New developments in Safety Pharmacology
  • Practical part in groups (cardiovascular and CNS laboratories)

Course Co-Directors

Dr. Andrea Greiter-Wilke, F. Hoffmann–La Roche Ltd.
Dr. Martin Traebert, Novartis Ltd.

Course Topics and Schedule

Course Documentation

Two weeks in advance of the course all presentations will be accessible to the participants for download or own printing, since no printouts will be distributed during the course

Venue map

Hotels in Basel

Ground Transportation

From Basel SBB (Swiss Railway) station: Tram 8 to „Kleinhuenigen“ or Tram 11 to „St. Louis Grenze“. From “Basel Badischer Bahnhof” (German Railway Station): Tram 6 to „Allschwil“. Leave tram at „Marktplatz“

Language

The course will be held in English

Course Fees

EUR 275,-- for members of the Swiss Society of Toxicology or the German Society of Pharmacologiy and Toxicology
EUR 600,-- for non-members
EUR 120,-- for PhD students and members of both Societies without regular income

Registration

This course is part of DGPT Modular Training Programme in Toxicology ("Fachtoxikologe/in DGPT") and the registration has to be made via the German Society of Toxicology.

A limited number of places will be directly offered by the Swiss Society of Toxicology. In addition, it is possible to register for single days. For booking through the Swiss Society of Toxicology, use the Contact form