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A Guide to European Union Pharmaceutical Regulations
Drug and Market Development Publishing, Oct 2003, Pages: 65
This Guide is for anyone engaged in marketing human medicinal products within the ever-changing European Union (EU).
Companies seeking to market their human medicinal products within the EU face many choices when it comes to seeking marketing approval.
The Guide reviews the national and pan-European regulatory mechanisms within the EU as well as the processes for effecting change. Further, the Guide describes the prevailing trends in the management of EU healthcare and the particular problems facing the pharmaceutical sector.
This Guide to EU Pharmaceutical Regulations provides a thorough overview of the current and future framework and policies of the European Union.
Get answers to these crucial questions:
- What are the current regulatory requirements for registration of medicinal products in the EU?
- What changes are being planned for the way in which products are approved in the run-up to enlargement of the EU from 15 to 25 Member States in May 2004?
- Through which Web sites is it possible to keep up-to-date with these ongoing changes?
- Are the downward pressures on healthcare costs experienced in the USA being replicated in the EU?
- What special controls exist for the registration of orphan medicinal products?
- What are the Rules Governing Medicinal Products in the European Union, and how are they applied?
- How is the EU implementing the Common Technical Document?
Who is responsible for the control of medicinal products at a national and pan-European level?
This Guide Will Prove Beneficial to Those Individuals Responsible for:
Regulatory Affairs, Clinical Studies, Research & Development, Legal Affairs, Business Development, Strategic Planning, and other major decision-makers at companies involved in the direct manufacture of human medicinal products of all types or at companies providing support services to these manufacturers.
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