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Regulation & Policy

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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Title Publication Date Price
Pharmaceutical Pricing and Reimbursement
Reference Pricing and Economic Evaluations Will Dominate Future Pricing and Reimbursement Strategies
February 2010 £2310
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products
China Pharmaceutical Guidebook Series (4) (3rd edition)
October 2009 £495
Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies
China Pharmaceutical Guidebook Series (1) (3rd edition)
October 2009 £495
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:A Guidebook of Registration Application for Imported Chemical Drugs
China Pharmaceutical Guidebook Series (2) (3rd edition)
October 2009 £495
China's Guidebook for Pharmaceutical Patent Protection
October 2009 £985
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:A Guidebook of Registration Application for Imported Traditional Chinese Medicines and Natural Medicines
China Pharmaceutical Guidebook Series (3) (3rd edition)
October 2009 £495
Pricing and Reimbursement: Innovative Risk-Sharing Strategies
July 2009 £2510
Prospects for Legalizing Drug (Re-)Importation to the United States
June 2009 £970
Complete Guide to the 2009 PPRS, NICE and other Pharmaceutical Cost Containment Measures in the United Kingdom
April 2009 £850
2009 CFR/ICH GCP Reference Guide (Spiral Bound)
April 2009 £9
2009 CFR/ICH GCP Reference Guide (Perfect Bound)
April 2009 £8
IND: Submissions
February 2009 £195
Pricing and Reimbursement in Key Asia Pacific Markets
January 2009 £1320
Outcomes-Based Pharmaceutical Pricing
Meeting Stakeholder Needs
December 2008 £5080
Competitive Intelligence Policies, Ethics and Data Collection
Navigating The Gray Zone
November 2008 £3545
Outcomes-Based Pharmaceutical Pricing:
Meeting Stakeholder Needs
September 2008 £5080
Valuing Pharmaceutical Innovation
Pricing and Reimbursement for Innovative Therapies
July 2008 £1995
Pharmaceutical Pricing and Distribution in Japan
The keys to success in the world's second largest market
June 2008 £1450
Pricing & Reimbursement - Seven Major Markets Update
May 2008 £1980
Major World Markets for Stents and The Economics of Drug-Eluting Technology
May 2008 £1850
Medical Affairs
Delivering Strategic Value
March 2008 £5080
Monitoring and Ensuring Pharmaceutical Compliance
March 2008 £5080
New Drug Development
A Regulatory Overview (8th Edition)
January 2008 £96
Licensing Strategies - Examining Todays Pharmaceutical Licensing Trends
November 2007 £5020
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 £1320
Validation of Pharmaceutical Processes, 3rd edition
September 2007 £170
A Guide to Drug Pricing and Reimbursement
September 2007 £1580
Validation and Qualification in Analytical Laboratories, 2nd edition
August 2007 £130
Legislation and Industry Status of Human Organ Transplantation in China
May 2007 £99
Pharmacoeconomics and Health Outcomes
Driving Formulary Access and Reimbursement
May 2007 £2905
Rules and Guidance for Pharmaceutical Manufacturers and Distributors
February 2007 £40
Good Laboratory Practice Regulations
4th edition
February 2007 £95
How to React to Parallel Trade
January 2007 £1095
Eu Paediatric Medicines Regulation
Boon or Burden?
January 2007 £1095
IMS Pharmaceutical Pricing & Reimbursement Concise Guide 2007
January 2007 £1320
State-by-State Clinical Trial Requirements Reference Guide
November 2006 £33
Prescribing Data Restriction Program (PDRP), The
Critical Assessment and Best Practices
September 2006 £990
Pharmacovigilance
Risk Management in Practice
July 2006 £1499
Pricing and Reimbursement in the US
Innovation and robust pharmacoeconomic analysis are ke
June 2006 £4290
Parallel Trade in Europe and the US
The challenges facing pharma
April 2006 £2435
Pharmaceutical Pricing, Reimbursement and Parallel Trade 2006
March 2006 £1320
Managed Markets
Pharmaceutical Reimbursement Strategy, Organizational Structure and Medicare Part D
February 2006 £2905
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 £2885
Integrated Intellectual Asset Management
A Guide to Exploiting and Protecting your Organization's Intellectual Assets
December 2005 £55
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
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
Introduction to Pharmaceutical Calculations
2nd Edition
March 2005 £19.95
Write it Down
Guidance for Preparing Effective and Compliant Documentation, Second Edition
March 2005 £130
FDA Administrative Enforcement Manual
February 2005 £100
Lincoln Technologies: Strategic Pharmacovigilance
January 2005 £445
Worldwide Regulatory Compliance Issues in Life Science
January 2005 £2500
U.S. Regulatory Reporter Newsletter for Addresses in Europe
December 2004 £280
U.S. Regulatory Reporter Newsletter for Addresses in North America
December 2004 £260
Introduction to the Pharmaceutical Regulatory Process
November 2004 £94
Biologics Development
A Regulatory Overview 3rd Edition (2004)
October 2004 £56
Handbook of SOPs for Good Clinical Practice
Second Edition
February 2004 £140
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 820
CFR 21 Part 820 Quality System Regulation (10 Pack)
November 2003 £55
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 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
Protecting Medicines and Pharmaceuticals
A Manual of AntiCounterfeiting Solutions
December 2002 £112