Market Access Archives | Page 6 of 7 | Report Store

US Regulatory Issues

Key regulatory developments include the new Prescription Drug User Fee Act (PDUFA-V), which aims to improve interaction between the FDA and drug developers.

November 2, 2016

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France Regulatory Issues

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The much-criticized delay in the removal of marketing authorization for Servier’s Mediator in France has had profound implications for reform of the country’s regulatory system.

November 2, 2016

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Germany Pricing and Reimbursement

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The German pharmaceutical market has historically been the most attractive European market due to high prices and high drug utilization. However, this is changing, with comparability assessment requirement raising the bar for achieving a higher price point.

November 2, 2016

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US Pricing and Reimbursement

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Historically, few pricing controls have been implemented in the US; however, there is greater pressure to implement controls to help contain costs associated with the expansion of public healthcare provision.

November 2, 2016

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Germany Regulatory Issues

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Data indicates that companies often favor Germany when choosing a reference member state (RMS) in order to gain approval under the decentralized procedure, perhaps reflecting overall a fast pace of regulatory review.

November 2, 2016

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Indonesia Healthcare System Overview

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With only 2.6% of GDP spent on healthcare in 2010, the healthcare system in Indonesia has huge potential for growth.

November 2, 2016

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Indonesia Regulatory Issues

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Challenges for foreign pharma companies in relation to Indonesia’s pharma system include lengthy and variable approval periods, compulsory licenses, and counterfeits.

November 2, 2016

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The Evolution of Pharmaceutical Sales Strategies Continues

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Pharmaceutical sales forces have evolved from the traditional structure, which was dominated by considerable numbers of field-based representatives detailing a range of products to different physicians on a regular basis.

November 1, 2016

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India Regulatory Issues

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The drug approval process in India is not complex, although poor patent protection and government policies favoring generic companies make multinational companies (MNCs) wary of launching new drugs in the country.

November 1, 2016

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Turkey Regulatory Issues

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The mandatory requirement imposed by the Turkish authorities for overseas manufacturers exporting pharmaceutical products to Turkey to obtain Good Manufacturing Practice (GMP) certification issued by the Turkish Ministry of Health is causing inordinate delays in the registration of new pharmaceutical products in Turkey. However, these delays can be resolved once the US Food and Drug […]

November 1, 2016

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Key Trends in BRICMIST Market Access

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Brazil, Russia, India, China, Mexico, Indonesia, South Korea, and Turkey – known collectively as the BRIC/MIST countries – have been a source of welcome growth for a pharmaceutical industry struggling to generate significant gains in its traditional core markets.

October 17, 2016

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Asthma Pricing, Reimbursement, and Access

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The next wave of key therapies in asthma includes biologics, with interleukin (IL)-5 inhibitors first to reach the market.

October 17, 2016

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Chronic Obstructive Pulmonary Disease (COPD): Market Access Pricing & Reimbursement

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Long-acting beta 2 agonist/long-acting muscarinic antagonist (LABA/LAMA) combination inhalers have been gaining traction due to an expanding evidence base for their wider use, and competitive pricing.

October 17, 2016

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Psoriatic Arthritis: Market Access Pricing & Reimbursement

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Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriatic arthritis market.

October 17, 2016

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CER, HEOR, and Value-Based Frameworks in the US

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It is no secret that Americans spend heavily on healthcare – in 2013, US healthcare expenditure totaled nearly $3bn ($9,255 per person) and accounted for 17.4% of gross domestic product.

October 17, 2016

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