This course will provide participants with an overview of the current knowledge on the clinical assessment and follow-up of drug safety post-approval and human safety. Drug safety in human patients is the ultimate goal of drug safety scientists. Because limitations of patient populations studied during drug development and uncertainties related to potential drug-drug interactions or rare or idiosyncratic adverse reactions, it is important to pay careful attention to human safety to achieve a better understanding of the safety of drugs on the market used in a wider patient population, for long treatment duration and on various co-medication compared to the population included in the approval package. Human safety plays an important role for assessing drug safety profile in daily conditions of use, which includes adherence to recommended modalities of therapeutic use (pharmacovigilance) as well as exposures deriving from accidental or intentional acute poisonings (clinical toxicology and toxicovigilance), misuse or abuse of therapeutic agents (pharmacodependence) or unintended indications. 

This course will introduce the emerging area of the safety science of the therapeutic application of stem cells, and will address all the key issues that need to be considered by developers of these therapies, including academics and the pharmaceutical/ biotech industry, as well as the important area of regulation. Other new areas of therapy will also be considered, such as genetically-engineered cells. The use of stem cells in the screening of conventional drugs for efficacy and particularly safety will also be investigated. UK and European leaders in these fields, from Industry, Academia and the Regulatory Agencies, will contribute teaching sessions in a small, informal and interactive learning environment. 

The European project NanoReg aims at standardisation of materials in industrial production. Swiss industry is particularely invited to become involved in the activities. Meet with the experts in Bern on 1st October 2014. The annual event in Bern brings together all national competences related to regulation aspects of nanomaterials from federal offices to industry. NanoReg representatives will show the outlines of the project, an overview on achieved Swiss research results and perspectives for future activities, in which new Swiss (industrial) participants can take part. Moreover, related research topics as well as support measures from Euresearch will be presented by the NCP for Nanotechnologies, Advanced Materials and Advanced Manufacturing and Processing (NMP).

Discovering and developing new and better drugs for patients requires the collaboration of an extraordinary number of specialists across many disciplines and organizations. MipTec 2014 introduces new topical forums to cover an even broader range of these disciplines: Infectious diseases, drug discovery information management, and clinical development. As a global hub of pharmaceutical research and development, Basel offers the perfect setting to bridge the gap between the academic life sciences, early drug discovery, and clinical drug development. MipTec 2014 aims to achieve this by providing a platform for networking and scientific exchange for academic and industrial scientists.

A unique feature of this course is that the bioanalyses of both small molecules and biopharmaceuticals are discussed side by side and that the technical aspects of method development are reviewed in the light of the final assay objectives in industry. Integrated bioanalytics represent a variety of important methods to acquire reliable information about the state of a biological system, e.g. by analysing tissues, body fluids. As compounds differ in their physico-chemical properties, appropriate analysis strategies are required for sample separation, pre-treatment, detection methodology and validation. Students will acquire the necessary knowledge to understand the most common methods applied and will be able to define the basic needs to develop, prepare and perform integrated biomolecular analyses, as well as to review and evaluate studies in the bioanalytic field. 

International experts will gather for an open scientific debate on the harmonisation of human and ecological risk assessment of combined exposure to multiple chemicals (chemical mixtures). Discussions will focus on the following topics of relevance to both human and ecological risk assessment of combined exposure to multiple chemicals: i) mechanistic models for hazard assessment; ii) harmonisation of methods for combined exposure assessment; iii) the use of OMICs and in silico methods for risk assessment; and iv) application of science-based uncertainty factors and approaches for risk characterisation using mechanistic approaches.

This is the 50th Congress of the European Societies of Toxicology. Its aim is to “Advance Science for Human and Environmental Health” and we have an exciting programme highlighting new and innovative science and current regulatory topics. There will be a mix of plenary and keynote lectures, symposia, workshops and a full continuing education programme. In addition, there will be interactive poster sessions and a dynamic trade exhibition. EUROTOX 2014 will be THE meeting place for toxicologists from around the world to come together to meet and discuss the key issues facing the discipline today.

Please find the programme here.

The main sessions will cover the following topics: Drugs in semen (HESI DART Symposium), the Role of Primary Cilia in Abnormal Development, Developmental Neurotoxicology and Behavior, Adverse Outcome Pathways, Imaging Techniques, Mandatory Folic Acid Fortification (ETS/TS exchange), and Education Course - Molecular Pathways in Embryology.