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Pharmaceuticals Policy and Law - Volume 12, issue 1-2

Purchase individual online access for 1 year to this journal.

Price: EUR 100.00
The new international review, Pharmaceuticals Policy and Law, appears with the aim of studying and evaluating the legal status of medicinal products in the European Union, and its implications in other markets such as the USA and Japan, without neglecting the specific problems of developing countries.

Pharmaceuticals Policy and Law
intends to participate in the process of world convergence of pharmaceutical legislation helped by a network of academic centers specializing in pharmaceutical law, without omitting a scientific, economic and social approach to medicinal products.

The specificity of medicinal products conditions their legal status. Legislation regulating other goods cannot be applied to them. To begin with, they are the result of scientific and technical innovation. Research policies determine their progress. The pharmaceutical industry is, by nature, multinational. But, next to these global trends, different traditions still remain at a national level. Within the EU, barriers to free trade in medicinal products still remain despite more than thirty years of harmonisation. The social dimension of medicinal products is complex and very significant in the preoccupations of our societies. Patenting is essential but not sufficient. The life-cycle of medicinal products is protected by professional responsibility, required in the general concept of health safety. It is important to remember their ethical dimension, including research and innovation in new fields such as genetic manipulation and biotechnology, which requires social consent to preserve human dignity and fundamental rights.
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Innovative Medicines development in Europe

The role of the Advanced Therapies initiative

The role of the Orphan Drugs initiative

The role of the Paediatric Initiative

EMA initiatives for innovation

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The European Innovative Medicines Initiative

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The COMP perspective

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Clinical trial design and management

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Prescription data on orphan drugs

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Paediatric Medicines

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Paediatric Orphan Drugs

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Paediatric device development

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Paediatric Committee – PDCO

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Needs and PIPs by therapeutic classes: Oncology

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Promoting innovation at National level

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Orphan drugs in haematology

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Paediatric intensive care

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Erratum