|Application deadline:||January 2014|
|Tuition fee:|| |
|Start date:||January 2015|
|Credits:|| 3 ECTS |
|Duration full-time:||5 days|
|Delivery mode:||On Campus|
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This course deals with biomolecular analysis, and provides insight and knowledge on most aspects of method development, validation, and application. A unique feature of this course is in the fact that the bioanalysis of both small-molecule drugs and biopharmaceuticals is discussed. Experts from the field with hands-on experience will be there to guide you through the different steps and strategies of method development, optimization, validation and application. Method development is discussed from both analyte property and application perspective.
Key areas covered by this course
* Physico-chemical parameters at the basis of method development
* Bioanalytical strategies for small molecules: sampling, sample pretreatment, separation, detection, validation and data handling.
* General consideration in bioanalytical strategies for biopharmaceuticals
* PK, PD, and biomarker assay formats
* Development of immunogenic assay strategies: background, assay strategies, predictive immunogenicity
Upon completion of the course attendees will be able to evaluate studies in the bioanalytical field and communicate with experts in the field.
The course consists of one week face-to-face training by academic and industry experts from the field, given on-site and concluded by an exam. This week is followed by an optional second week of self-study and/or e-learning.
A syllabus containing an introductory chapter, lecture hand-outs, list of abbreviations, definitions and reading material will be provided by the course leader 14 days prior to the course. The material for the home assignment will be provided during the first week of the course.
Prof.Dr. Wilfried Niessen, Faculty of Sciences, VU University Amsterdam, Amsterdam, The Netherlands
Dr. Christian Herling, Novo Nordisk, Copenhagen, Denmark
Participants are typically science, medical or veterinary graduates either currently working in a safety science environment or seeking to gain knowledge on safety sciences at a specific time-point of their career. Competence in both written and spoken English to an IELTS level or equivalent of 7.0 is a requirement.
The course (including the second week home assignment) is accredited by 3 ECTS credits (Masters level). Assessment for accreditation will be done by the course directors based on a 2-hour written examination on the last day of the course, and an evaluation of the home assignment. It also meets the criteria for continuous professional development (CPD) diplomas as it will be part of a (forthcoming European) Masters of Advanced Safety Sciences degree.