http://www.reportbuyer.com/rss.htmlBuy the information you need on Pharmaceutical Regulation & Policy. Our catalogue of reports includes specific information on Pharma Compliance, Patent Protection and Drug Registration.en-gbReportbuyerservice@reportbuyer.comenquiries@redwiredesign.comhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/pricing_reimbursement_innovative_risk_sharing_strategies.html Novel niche biologics entering the market require high price points in order to provide manufacturers with a return on investment. However, with heightening regulatory scrutiny and increasing cost-pressures, a balance must be struck between incentivizing Pharma to develop novel drugs with high unmet needs, and that of the healthcare payers which fund healthcare costs. Overview of the different types of risk-sharing agreements adopted by manufacturers Insight into the utilization of such schemes in the UK, US, Italy and Australia Examination of the pros and cons of risk-sharing agreements Identification of key strategic recommendations for optimizing risk-sharing strategies Risk-sharing schemes are ideal if a well-established biomarker can be used to unambiguously determine if a patient has responded to treatment, however for many other oncology drugs relevant biomarkers still need to be discovered hence impeding a more widespread adoption of these schemes. 320815be7ac70d8c765ead8a2ddc8350Tue, 07 Jul 2009 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/prospects_legalizing_drug_re_importation_united_states.htmlPresident Barack Obama said during his election campaign he would 'allow Americans to buy their medicines from other developed countries if the drugs are safe and prices are lower outside the US'. He began delivering on this promise with a fiscal 2010 budget request for funds 'to allow the FDA to begin developing policies for drug importation'. Earlier in 2009, with strong bipartisan support, Senator Bryon Dorgan (D-ND) re-tabled a bill to allow both personal and commercial drug importation. c2f4b781b126a68b7f111ce505f6b30fSat, 06 Jun 2009 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/pharmacovigilance_report_analysis_2009.htmlPharmacovigilance has been expanding in recent years, as companies are required to monitor drug safety post launch. Drug safety issues, such as those raised by Vioxx earlier this decade, have led to increased risk-averseness by regulators, with greater post-marketing assessment of drugs. Many regulatory agencies require detailed pharmacovigilance, with companies bearing extra costs, our new report also observes. d14e195e6ba7fdc975a4c8cccbcbbb0aTue, 21 Apr 2009 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/pricing_reimbursement/complete_guide_2009_pprs_nice_pharmaceutical_cost_containment_measures_united_kingdom.htmlIn an otherwise volatile pharmaceutical world, 2009 has seen two notable and durable anniversaries, the implementation of the tenth re-negotiated Pharmaceutical Price Regulation Scheme in January and the tenth birthday of the National Institute for Health and Clinical Excellence in April. PPRS and NICE, are among abbreviations most widely recognised, but their structures, functions and ways of working are often less than fully understood. Complete Guide to the 2009 PPRS, NICE & other Pharmaceutical Cost Containment Measures in the UK delivers what it says in the title. 386669a087086b3a6b0fc8413cdcfd22Wed, 15 Apr 2009 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/2009_cfr_ich_gcp_reference_guide_spiral_bound.htmlBack by popular demand and newly updated for 2009! Our 2009 CFR/ICH GCP Reference Guide contains: FDA Code of Federal Regulations, Good Clinical Practice parts 11, 50, 54, 56, 312, & 314. Good Laboratory Practice Part 58 ICH Guidelines Good Clinical Practice (E6) and Clinical Safety Data Management (E2A) The European Union Clinical Trials Directive and The European Union Good Clinical Practice Directive. New Feature for 2009! "Editor's Notes" that alert you to changes to the Federal Register that will take effect after the April 1, 2009 publication date. 2c783f7e962529ec342aee4b180211b6Sat, 04 Apr 2009 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/2009_cfr_ich_gcp_reference_guide_perfect_bound.htmlBack by popular demand and newly updated for 2009! Our 2009 CFR/ICH GCP Reference Guide contains: FDA Code of Federal Regulations, Good Clinical Practice parts 11, 50, 54, 56, 312, & 314. Good Laboratory Practice Part 58 ICH Guidelines Good Clinical Practice (E6) and Clinical Safety Data Management (E2A) The European Union Clinical Trials Directive and The European Union Good Clinical Practice Directive. New Feature for 2009! "Editor's Notes" that alert you to changes to the Federal Register that will take effect after the April 1, 2009 publication date. 16e3b68c3cc0eb731c62a0443781d558Sat, 04 Apr 2009 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/martindale_36th_edition.htmlMartindale provides reliable, unbiased and independently evaluated information on drugs and medicines used throughout the world. In addition to encyclopaedic information on drugs used clinically it also includes selected veterinary and investigational drugs, pharmaceutical excipients, herbal and complementary medicines, vitamins and nutritional agents, vaccines, radiopharmaceuticals, contrast media and diagnostic agents, drugs of abuse and recreational drugs, toxic substances, disinfectants and pesticides. First published in 1883 under the title The Extra Pharmacopoeia, the pharmacists who form the current in-house editorial team build on 120 years' experience to bring you the new 34th edition in hardback. e8df9722a3ff03ac053880fae7cb15d4Tue, 03 Mar 2009 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/pricing_reimbursement/cdr_tracker_2008_annual_report.htmlThe CDR Tracker® 2008 Annual Report a provides a year-over-year analysis of the activities of Canada's Common Drug Review and public drug plans in Canada. . 1ae9e78ee2a0e7612f1ddc6bab55ee87Sun, 01 Mar 2009 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/building_effective_regulatory_relationship_fda.htmlThough science remains the fundamental engine behind successful New Drug Applications, effective communication between pharmaceutical companies and the FDA at each stage of this process stands as a vital ingredient in securing approval for a new therapy. Applicant companies that frequently gain approval and first approvals - and avoid delays or, worse, the nebulous and costly "complete response" letter - brandish not only good science but also cultivate and sustain strong working relationships with the FDA and its staff. The topic of informal working relationships between pharmaceutical representatives and the FDA is a sensitive one for all parties. 3a83a1e5ba55fa1d98498ff3a442d23dMon, 02 Feb 2009 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/ind_submissions.htmlIND Submissions: A Primer provides a "hands-on" approach that teaches regulatory professionals - novice and veteran alike - to work with the regulations, guidance documents, content templates, contributing authors, and style guides necessary to write an IND. The book's writing tips show regulatory professionals how to produce a range of U. S. 562de8a7794d55cc98f4b489e6bca26eMon, 02 Feb 2009 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/pricing_reimbursement_key_asia_pacific_markets.htmlIntroductionWith the Asia-Pacific markets growing rapidly, they are becoming increasingly attractive for Pharma to enter. However, a number of key P&R developments and reforms are set to change the healthcare environment in the next few years, as healthcare is made more accessible to the poor and elderly. ScopeInsight into pricing and reimbursement strategies in Australia, Singapore, China and Hong KongAnalysis of drivers and barriers for entering Australia, Singapore, China and Hong KongOverview of healthcare systems in Australia, Singapore, China and Hong KongIdentification of trends shaping national P&R strategies and their impact on branded PharmaHighlightsIn Australia, a high level of evidence is needed to show clinical and cost effectiveness, thus clearly pointing to a barrier for entering the Australian market. f4ce69b63ed8bc6943ad7130446b6f36Thu, 01 Jan 2009 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/drug_approval_process_europe_outlook.htmlThis research deals with the drug approval process in Europe by focussing on the various marketing authorisation procedures, price controls and parallel trading. A snapshot of the biosimilars approval process is also provided along with the key strategic recommendations. . a403a091a7881b88034092d617b4a11fFri, 12 Dec 2008 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/pricing_reimbursement/valuing_pharmaceutical_innovation.htmlDeveloping, manufacturing and marketing innovative new pharmaceutical drugs is highly complex and involves significant investment. Establishing an acceptable return on investment requires generating sufficient sales revenues which in turn requires maximizing market access at the highest possible price. . c6b0dad24af96502a09ed061f9d1f530Tue, 01 Jul 2008 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/latest_chinese_regulations_imported_drug_registration.htmlSince the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which gave a fillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2006, sales of imported drugs have shared one fifth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door to a lucrative drug market for overseas pharmaceutical companies. 4bd2b212d1ebebf3a65d890b1146cdaaSat, 21 Jun 2008 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.comChina is expected to become the fifth largest drug market in the world by 2010 with a growth rate of 20-25 percent per annum in next three years. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door to a lucrative drug market for overseas pharmaceutical companies, which attracts more and more overseas pharmaceutical manufacturers and producers to enter such drug market and seize a larger part of such drug market. However, the Chinese social environment for the protection of intellectual property right is complex. 6557779bd46696407187abeb899c0922Sat, 21 Jun 2008 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/pricing_reimbursement/pharmaceutical_pricing_distribution_japan.htmlNo serious multinational can afford to ignore Japan, but it remains a tough and highly competitive market to crack, with the environment for developing and marketing medicines dominated by price. Virtually no new prescription brand can be introduced without a yakka (reimbursement price) set by the government. Innovative new drugs receive price premiums while others are capped at the price of older entrants. e01fb962e18308fd9562b2694d53bc22Sun, 01 Jun 2008 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/major_world_markets_stents_economics_drug_eluting_technology.htmlSince the arrival of drug-eluting (called drug-eluding by some) technology a few years ago with the promise of reducing restenosis, questions abound surrounding the future of the stent market: After numerous clinical studies and mixed cost-effectiveness results, how is drug-eluding technology expected to peform in the future? What can companies do to best market this technology in the healthcare system of the US and 6 other major world markets? What are the market trends to watch that will determine growth in this field in the coming years? What companies have already established a leadership position in stents and what do start ups have to do to join them? Major World Markets for Stents and The Economics of Drug Eluding Technology, written by Kalorama Analyst Dr. Kenneth Krul, takes a hard look at these questions with economic analysis unmatched by any resource. The field of drug-eluting stents remains an exciting technological innovation that will be a major part of cardiovascular intervention technologies over the next ten years. 068028c44dd6b638ddcc3def289f3b01Thu, 01 May 2008 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/monitoring_ensuring_pharmaceutical_compliance.html Compliance is at the forefront of pharma companies' minds today. Companies face the threat of staggering fines and increased scrutiny from regulatory bodies. A growing level of public distrust of the industry also carries a negative effect on companies' reputations. f4f5de37aaf2d6fd41f827a137ec65eaSat, 01 Mar 2008 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/licensing_strategies_examining_todays_pharmaceutical_licensing_trends.html With Pharma struggling to maintain its pipelines and portfolios with products developed in-house, companies are increasingly turning to licensing. However, the search for late-stage developmental products is becoming tougher and more expensive, and companies are now looking towards licensing earlier-stage compounds. Overview of drivers and resistors of licensing deals, with recommendations and case study analysis of how companies can optimize the licensing process Examination of how to successfully navigate the licensing process, with analysis of how companies are looking to modernize their licensing strategies Analysis of key product deals during 2005-06, analyzing trends for in-licensing, co-development, out-licensing and marketing & promotion deals Assessment of drug discovery deals and technology deals, made by the top 20 pharmaceutical companies during 2005-06 The constant demand for late-stage product candidates has led to spiraling deal costs. 6ba0d8902a9a3e086117b4607828291eWed, 14 Nov 2007 12:00:00 GBPharma & Healthcare/Regulation & Policyhttp://www.reportbuyer.com/pharma_healthcare/regulation_policy/pricing_reimbursement/pricing_reimbursement_series.html NICE is one of the most advanced cost effectiveness assessment bodies operating in the major pharmaceutical markets. Since it was established it has had an increasing impact on the availability of new drugs in England and Wales, but has also generated considerable attention globally. Overview of the UK pricing and reimbursement system and the role NICE plays in it Analysis of the key issues facing NICE and the measures being taken to rectify them Discussion of case studies to illustrate the effect of and response to key NICE rulings NICE plays a key role in the UK healthcare system although it does not currently assess all new drug approvals. 71f4d34113a11c1f89dac60c44ab5e86Wed, 26 Sep 2007 12:00:00 GBPharma & Healthcare/Regulation & Policy