Design-Elememt

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Reflection paper “Complex Study Designs – Relevance for Advances in medicine"


The evolving scientific knowledge of disease causes requires the use of complex study designs. For these reasons, there is a high interest by the pharmaceutical industry to closely cooperate with both the regulatory authorities and ethics committees (that approve the conduct of clinical trials/grant their favourable opinion, respectively) and HTA bodies in developing and implementing these study designs. It should be explored in joint discussions what the requirements for approving and assessing these study designs are.
You may also find a version in german language.
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vfa/vfa bio Position Paper "Biopharmaceuticals – Original Products and Biosimilars"


vfa and vfa bio, representing biopharmaceutical companies with and without biosimilar activities, are committed to competition between biopharmaceutical therapy options so as to improve health care for patients. We advocate for general conditions for the quality-assured use of bio-pharmaceuticals - original products and biosimilars:
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vfa/vfa bio Position Paper Orphan Drugs


Given the large number of orphan diseases and because of the huge medical need for new therapeutic options especially for people with rare diseases, there is still a very great deal of work to be done in this area. vfa and vfa bio are strongly committed to rigorously promoting the development of new therapies for orphan diseases throughout the value chain.
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vfa/vfa bio Position Paper Nanobiotechnology / Nanomedicine


By international comparison, Germany holds a strong position in the field of nanotechnology, a cross-sectional technology, implemented in many different fields. Nanobiotechnology, or the application in areas of medicine, pharmacy and life sciences to be precise, has the potential of opening up new or improved/earlier diagnostic or therapeutic opportunities for diseases that were previously insufficiently curable or completely incurable.
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US publication contains incorrect calculation of the development costs for cancer drugs


New analysis of development costs for cancer drugs by US medics is flawed. The sample is not representative. Essential cost drivers are not included.
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Pharma Dialog – The work starts now (Press Release 12. April 2016)


Today, the German government submitted its report on the Pharma Dialog. The agencies involved were the Ministry of Health, the Ministry for Education and Research, and the Ministry for Economic Affairs and Energy.
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Position paper “Cost development for clinical trials in Germany”


Currently, Germany is well prepared in principle and is internationally competitive as a location for conducting clinical trials. This is demonstrated by its No. 1 rank in Europe and No. 2 worldwide (behind the United States) in clinical trials. However,...
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Statement for the German Federal Ministry of Health: On the experience of the research-based pharmaceutical companies with the Act on the Restructuring of the Pharmaceutical Market (AMNOG)


(Written inquiry of the German Federal Ministry of Health to the associations on February 14, 2013)
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vfa Press Release 003/2014

"Trial and error” at the patients’ expense


"Trial and error” at the patients’ expense
(© vfa / H. Klappert)
The German Bundestag is implementing a number of pharmaceutical policy changes within the scope of the 14th law amending Book V of the German Social Code.
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vfa Press Release 033/2012 - Monday, November 19, 2012

Great potential!


The service sector is important, especially for the state of Berlin. Nonetheless, Berlin needs industry, and Berlin has industry. Added value and, as a result, jobs, high taxes and profits come from industry. In this respect, the pharmaceutical industry has a special significance for Berlin. It is one of the city’s few industrial growth centers and a growth engine within the region’s important health care sector.
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vfa position on endpoints for oncological therapies


Due to the severity of oncological diseases, pivotal studies are subject to special methodological characteristics that must be taken into account during the selection of endpoints and the interpretation of the results.
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vfa Position Paper

"Qualified Person (QP)"


Over the past few years, the requirements for pharmaceutical production and control have fundamentally changed. For example, based on the implementation of the ICH Q8, Q9 and Q10 guidelines, more importance is assigned to process control and quality assurance. As a result, the final quality only serves the purpose of formal confirmation. Consequently, these changes also entail modifications in the requirements profile for the qualified person pursuant to Section 14 of the Medicinal Products Act/Art. 48 of Directive 2011/83/EC (hereafter referred to as Qualified Person/QP).
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The Pharmaceutical Industry in Germany

Germany: The Perfect Location for Research, Production and Sales - a publication by GERMANY TRADE & INVEST and vfa
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