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Deutsch
English
Clinical Development
Testimonial
„Die
Berufspraxis für Apothe- ker in der Pharmaindustrie ist mit einem hohen Mass an
Spezialisierung verbunden. Die Kursreihe „Pharmaceuticals – From Research to
Market“ liefert einen sehr guten Ein- und Überblick in die Branche, was für mich persönlich den täglichen
Arbeitskontext spürbar greifbarer und transparenter werden liess.“
Dr. Eva Politzki, Partner Manager Supply Chain bei einem internationalen Konzern in Basel
Dr. Eva Politzki
Scope
This course provides an integrated view of clinical development focusing on the conduct of clinical studies under regulations in Europe and Switzerland. The goal is to achieve an understanding of the principles of the clinical development process.
In particular, an introduction to Good Clinical Practice (GCP) and an overview of regulatory aspects of clinical development is given. Specialized lectures focus on the characteristics of each study phase from early exploratory to post marketing trials. Furthermore, participants learn the principles of drug safety, data management and monitoring.
The speakers will include experts from industry and service providers.
Audience
The course addresses individuals with a degree in pharmacy, medicine or natural sciences who work in the pharmaceutical or a related industry or for a service provider in this field. In particular:
- younger professionals working in clinical development (e.g. as CRA), who are looking for a comprehensive and practical introduction to this working field
- more experienced professionals working in clinical development wishing an update on current regulations and an overview of trends
- professionals working in other areas of the pharmaceutical industry (e.g. regulatory affairs, marketing, manufacturing) or for the health authorities, who seek to understand the principles of clinical development
- PhD students or other individuals planning a career in the pharmaceutical industry with special interest in this field
- persons aiming to achieve the postgraduate certificate (CAS) "Pharmaceuticals - From Research to Market"; this course is part of the curriculum (details on program)
Topics and speakers of course 2011
| Opening lecture | Dr. C. Winnips (Lunamed) |
| Preclinical Bridge to Clinical Development | Prof. R. Häcker (Harlan Laboratories) |
| Regulatory Aspects of Clinical Development | Dr. L. Riopel |
| First in Men (Phase I) Studies | Dr. R. Pokorny (Covance) |
| Proof of Concept (Phase II) Studies | Dr. S. Felix (Novartis) |
| Approval (Phase III) Studies | Dr. T. Imbach (Amgen) |
| Post-marketing (Phase IV) Studies | Dr. E. Gysling (Infomed) |
|
Good Clinical Practice (GCP) and QA |
PD Dr. G. Senti, CTC, University Hospital Zurich) |
| Drug Safety and pharmacovigilance | K. Hartmann (Crucell) |
| Data Management | Dr. P. Voermans (Roche) |
| Monitoring |
I. Kammermann (KMS), K. Huber (CTC, University Hospital Zurich) |
| Organizational and financial aspects of Clinical Development |
Dr. G. Lautscham (PRA) |
Course language
English
Dates
planned for 2013 (5 days)
on every course day from 9 am to 5 pm
Course location
ETH Zurich
Costs
CHF 2500.-
reduced prices for PhD students
Application
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