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Regulation & Policy

In this section you will find information products, including market research, covering regulatory issues concerning the global biotechnology & pharmaceutical industries, including Good Laboratory & Clinical Practice (GLP & GCP), pricing & reimbursement and drug approval in Europe, the US and Asia.

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Regulation & Policy


Title Sort Publication Date Sort Price Sort
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China’s Guidebook for Pharmaceutical Patent Protection

June 2008 £975
Latest Chinese Regulations for Imported Drug Registration
China Pharmaceutical Guidebook

June 2008 £905
Major World Markets for Stents and The Economics of Drug-Eluting Technology

May 2008 £1825
Monitoring and Ensuring Pharmaceutical Compliance

March 2008 £5015
Licensing Strategies - Examining Todays Pharmaceutical Licensing Trends

November 2007 £7600
Pharmaceutical Pricing And Reimbursement
Strategies For Market Access Across The Us, Europe, Japan And Other Key Geographies

November 2007 £1495
Pricing And Reimbursement Series
NICE Its Impact On The UK Healthcare System And Beyond

September 2007 £2005
A Guide to Drug Pricing and Reimbursement

September 2007 £1560
Validation of Pharmaceutical Processes, 3rd edition

September 2007 £170
Validation and Qualification in Analytical Laboratories, 2nd edition

August 2007 £130
Legislation and Industry Status of Human Organ Transplantation in China

May 2007 £48
Pharmacoeconomics and Health Outcomes
Driving Formulary Access and Reimbursement

May 2007 £5015
China Pharmaceutical Guidebook Series - Vol 1
A Comprehensive Guidebook for Foreign Pharmaceutical Companies

February 2007 £490
Good Laboratory Practice Regulations
4th edition

February 2007 £95
Rules and Guidance for Pharmaceutical Manufacturers and Distributors

February 2007 £40
China Pharmaceutical Guidebook Series - Vol 4
A Guidebook of Registration Application for Imported Traditional Chinese Medicines and Natural Medicines

February 2007 £490
How to React to Parallel Trade

January 2007 £1095
Eu Paediatric Medicines Regulation
Boon or Burden?

January 2007 £1095
Martindale 35th edition
The Complete Drug Reference

November 2006 £350
Prescribing Data Restriction Program (PDRP), The
Critical Assessment and Best Practices

September 2006 £980
Pharmacovigilance
Risk Management in Practice

July 2006 £1499
Drug Pedigree: FDA Says 2007

June 2006 £280
Pricing and Reimbursement in the US
Innovation and robust pharmacoeconomic analysis are ke

June 2006 £6495
Parallel Trade in Europe and the US
The challenges facing pharma

April 2006 £3690
Pharmaceutical Pricing, Reimbursement and Parallel Trade 2006

March 2006 £1305
Drug Safety Versus Consumer Privacy
Must We Choose?

February 2006 £835
Managed Markets
Pharmaceutical Reimbursement Strategy, Organizational Structure and Medicare Part D

February 2006 £2865
Pharmaceutical Regulatory Affairs in The Eu & US

January 2006 £1095
Patent Law and Practice in Pharmaceuticals

January 2006 £1095
Pricing & Reimbursement in Asia-Pacific

January 2006 £1095
Pharmaceutical Regulatory Industry

January 2006 £3160
Integrated Intellectual Asset Management
A Guide to Exploiting and Protecting your Organization's Intellectual Assets

December 2005 £55
Pharmaceutical Pricing in the US and Europe
Analysis of Resources, Strategy and Structure

November 2005 £2865
Guide to Pharma Pricing & Reimbursement Systems
Western Europe

November 2005 £970
Stockley's Drug Interactions
7th Edition

October 2005 £120
Food-Drug Synergy and Safety

August 2005 £74.99
EU Pharma IMPACTS

August 2005 £450
Dictionary of Pharmacovigilance
1st Edition

June 2005 £65
Pricing & Reimbursement of Medicines in the United Kingdom
Understanding the pharmaceutical market in the healthcare system

June 2005 £450
US Drug Reimportation
Prospects & Opportunities

May 2005 £495
Adverse Event Reporting and Pharmacovigilance
Making Drug Safety Happen

April 2005 £2500
Validating Pharmaceutical Systems
Good Computer Practice in Life Science Manufacturing

March 2005 £140
Regulations in Global Pharma Industry

March 2005 £50
Write it Down
Guidance for Preparing Effective and Compliant Documentation, Second Edition

March 2005 £130
Introduction to Pharmaceutical Calculations
2nd Edition

March 2005 £19.95
FDA Administrative Enforcement Manual

February 2005 £100
Lincoln Technologies: Strategic Pharmacovigilance

January 2005 £445
Pharmacoeconomics & Success in the Marketplace

January 2005 £1499
Drug Safety in the Post-Vioxx Era
New legislation, regulation and company strategies in Europe and the US

January 2005 £1495
Worldwide Regulatory Compliance Issues in Life Science

January 2005 £2500
Pharmaceutical Pricing Strategies
Price optimization, reimbursement and regulation in Europe, US and Japan

January 2005 £1495
Pharmaceutical Anti-Counterfeiting Strategies
Protecting profits through operational security, new technologies and industry partnerships

January 2005 £1495
U.S. Regulatory Reporter Newsletter for Addresses in Europe

December 2004 £155
U.S. Regulatory Reporter Newsletter for Addresses in North America

December 2004 £145
Introduction to the Pharmaceutical Regulatory Process

November 2004 £94
Biologics Development
A Regulatory Overview 3rd Edition (2004)

October 2004 £55
Pharmaceutical Pricing: global perspectives

September 2004 £625
State-by-State Clinical Trial Requirements Reference Guide

September 2004 £10
PharmaHandbook: European Union (EU)
A Guide to the International Pharmaceutical Industry

June 2004 £125
PharmaHandbook: Middle East & Africa
A Guide to the International Pharmaceutical Industry

June 2004 £125
PharmaHandbook: Asia, Pacific
A Guide to the International Pharmaceutical Industry

June 2004 £125
PharmaHandbook: North America
A Guide to the International Pharmaceutical Industry

June 2004 £125
European Pharmaceutical Regulation
Implications for Competitiveness, Innovation and a Single Market

March 2004 £150
Handbook of SOPs for Good Clinical Practice
Second Edition

February 2004 £140
Pharmaceutical Pricing & Reimbursement in European Union Accession Countries
A Concise Guide

January 2004 £995
Challenge of CMC Regulatory Compliance for Biopharmaceuticals, The

December 2003 £77.5
Electronic Record Keeping
Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

December 2003 £140
FDA Regulatory Affairs
A Guide for Prescription Drugs, Medical Devices, and Biologics

December 2003 £95
Computer Systems Validation
Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies

December 2003 £299
Compact Regs Parts 807, 812, and 814
CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)

November 2003 £54.99
Compact Regs Parts 820
CFR 21 Part 820 Quality System Regulation (10 Pack)

November 2003 £55
Compact Regs Part 58
CFR 21 Part 58 Good Laboratory Practice for Non-clinical Laboratory Studies (10 Pack)

November 2003 £55
Compact Regs Parts 50, 54, 56, and 312
CFR 21 Parts 50, 56, and 312 Good Clinical Practices (10 Pack)

November 2003 £85
Compact Regs Part 11

October 2003 £55
The Control of Entry Regulations and Retail Pharmacy Services in the UK
Response to Health Select Committee 5th Report

July 2003 £4.5
Pharmaceutical Pricing Compendium
A practical guide to the pricing and reimbursement of medicines

March 2003 £125
Health Economics in the Drug Life Cycle
Achieving success in drug discovery, development, reimbursement and marketing

January 2003 £695
Pharmaceutical Pricing and Reimbursement
A concise guide

December 2002 £995
Worldwide Pharmaceutical Regulation Series
2002

December 2002 £185
Protecting Medicines and Pharmaceuticals
A Manual of AntiCounterfeiting Solutions

December 2002 £112
New Drug Approval in the European Union

November 2002 £70
Pharmaceutical Pricing & Reimbursement Systems of CEE

June 2002 £300
Pharmacoeconomics
A concise guide

January 2002 £995
Good Laboratory and Clinical Practice
Requirements for Compliance in the Global Pharmaceutical Industry

March 2001 £39.99
Medical Device Development
A Regulatory Overview 2000

December 2000 £55
Emerging Pharmaceutical Markets
Potential & Problems

September 2000 £195
Pharmaceutical Regulation in Europe
Industry Challenges

May 2000 £150
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