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 |