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A Guide
to European Union Pharmaceutical Regulations: Practical & Political Perspectives
of the Changing Environment
Click to purchase:
A Guide to European Union Pharmaceutical Regulations: Practical & Political
Perspectives of the Changing Environment
Description:
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.
65+
Pages - 20+ Exhibits
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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.
D&MD's 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:
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What are the current regulatory requirements for registration of
medicinal products in the EU?
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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?
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Through which Web sites is it possible to keep up-to-date with
these ongoing changes?
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Are the downward pressures on healthcare costs experienced in the
USA being replicated in the EU?
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What special controls exist for the registration of orphan
medicinal products?
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What are the Rules Governing Medicinal Products in the European
Union, and how are they applied?
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How is the EU implementing the Common Technical Document?
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Who is responsible for the control of medicinal products at a
national and pan-European level?
Get up-to-speed on the ever-changing policies and procedures
of the EU |
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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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Table of Contents |
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Section |
Summary |
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1 |
The European Union: The Basics
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Introduction
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The EU: Structure
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How the EU is Governed
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Healthcare Trends in the EU
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2 |
Supporting the Pharmaceutical Regulatory Process
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EudraNet Portal
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The European Agency for the Evaluation of Medicinal Products (EMEA)
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Heads of Agencies in Europe
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European Experts
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The Pan European Regulatory Forum (PERF)
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The Enterprise DG of the EU Commission
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Enterprise DG Unit F2 - Pharmaceuticals - Regulatory Framework and Market
Authorisations
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European Federation of Pharmaceutical Industries and Associations (EFPIA)
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Association of the European Self-Medication Industry (AESGP)
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Other Important Interested Parties
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3 |
European Pharmaceutical Regulatory Processes
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Relevant Historical Perspectives
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Centralised Procedure - Overview
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Mutual Recognition Procedure - Overview
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Purely National Procedures - Overview
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The Basis of the System
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Product Name
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The Dossier
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Centralised Applications - Pre-submission Guidance
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Common Technical Document (CTD)
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The Electronic Common Technical Document (eCTD)
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4 |
Types of Application
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Complete/full and Independent
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Abridged
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Fixed Combination
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New Authorisation with an Already Authorised Active Substance
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Orphan Medicinal Products
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5 |
The Reform Process
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Initial Proposals for Reform
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The Industry's (EFPIA) Response
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The Commission's Response and Current Position
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6 |
International Perspectives
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Expansion of the EU
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International Harmonisation
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7 |
The Rules: Governing Medicinal Products in the
European Union
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The Rules: Introduction
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The Rules: Volume 1 - Pharmaceutical Legislation
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The Rules: Volume 2 - Notice to Applicants
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The Rules: Volume 3 - Guidelines - Medicinal Products for Human Use
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The Rules: Volume 4 - Good Manufacturing Practices for Medicinal Products
for Human and Veterinary Use
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The Rules: Volume 9 - Pharmacovigilance for Medicinal Products for Human
and Veterinary Use
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Date published:
10/1/2003
Number of pages:
65+
Category:
Drug Discovery
Industry:
Pharmaceutical & Biotech
Price Hard Copy
(US$):
$395.00
Interested in this
report:
peter.barfoot@bioportfolio.com
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