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Marketing Authorization & Regulatory Requirements for Drug Registration in...

Thailand is the second largest healthcare market in Southeast Asia after Indonesia making up roughly about 20% of the region’s expenditure. Thailand’s pharmaceutical market is the eight largest in the...

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Psoriasis – Clinical Trial Feasibility

Approximately one third of people with Psoriasis report being diagnosed before age 20. The prevalence of the disease in childhood and adolescence ranges between 0.5% and 2%. According to the World...

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Hong Kong – How To Utilize Clinical Trial Regulatory Process Effectively?

Hong Kong has a impeccable history of international research with impressive track record of conducting global clinical trials. It has an outstanding healthcare system and indicated as one of the...

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Clinical trial Regulatory Process – Mexico

Mexico is rapidly becoming a major player in the pharmaceutical and medical device industries. A recent report states that It’s the number one exporter of medical devices in Latin America and 8th in...

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Complicated Urinary Tract Infection & Acute Pyelonephritis – Clinical Trial...

A Complicated Urinary Tract Infection (cUTI), a severe class of UTI, one of most common infections in the world, is notorious and recognized as a menace globally. cUTI has relapsing and refractory...

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New Zealand – Clinical Trial Regulatory Process

New Zealand could be an interesting choice of region for national and international organisations seeking to pursue clinical research  and looking for most preferred destination in Asia-Pacific Region....

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Sri Lanka – Clinical Trial Regulatory Process

Sri Lanka was one of the first countries to embrace the concept of clinical trial registration.  The SLCTR was recognized as a Primary Registry of the Registry Network of the WHO‐ICTRP in March 2008,...

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Clinical Trials in Indonesia

Over a million people are currently living with TB in Indonesia, making up more than 10% of the world’s TB burden. Of the estimated 32 000 new cases of drug-resistant TB in the country, only about a...

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Clinical Trial Regulatory Process – Brazil

Brazil has grown exponentially in clinical research over the last decade. During the past 3 years, clinical trials in Brazil have grown significantly, with the country becoming one of the three most...

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Rare Diseases: Clinical Trials & Drug Development

Rare disease drug development is a rapidly expanding field with growing pressure for getting more orphan drug approved to treat rare diseases. There is a vast consensus among patients, health care...

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Rare diseases: Pre-clinical Studies and Clinical Trials in Orphan Drug...

The development of drugs in rare diseases provides great opportunities to pharma companies along with challenges that are required to overcome during drug discovery, pre-clinical, and clinical stages...

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Rare Diseases: Patient Recruitment Strategies in Clinical Trials

Over a few years, the rate of drug development in rare diseases is increasing, particularly in those countries where the regulators are offering various incentives for drug development in rare...

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Rare diseases: Drug development strategy

Rare disease drug development is gaining interest in pharma industries. Large pharmaceutical companies have been working for many years, and now startups, small and mid-range pharma companies are also...

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Clinical Trial Logistics – Rare Disease Clinical Trials

Clinical supply chain teams manage some typical challenges almost every day of their work in handling clinical trial logistics for local or global clinical trials. These include those related to...

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Rare Diseases: Regulatory Incentives for Development of Orphan Drugs – US & EU

Financial benefits, faster approvals and less stringent clinical data requirements are some important benefits that regulatory agencies across the world offer as incentives for development of orphan...

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Rare Diseases: Regulatory Incentives for Development of Orphan Drugs – JAPAN...

In a way to support and encourage pharma companies to work upon developing drugs or medical devices in rare disease, several country regulatory agencies are coming up with various benefits such as...

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Rare Diseases: Regulatory Incentives for Development of Orphan Drugs – Asia

In recent years there is a huge leap of pharma industry towards rare diseases and orphan drug developments due to the great support from regulatory authorities such as faster approval timelines,...

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Rare Disease Day 2020: Taking a step further

Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions make it much harder for them to get the right treatment....

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How To Choose a CRO?: Small and Mid-Size Pharma Companies

Increased outsourcing is seen in pharmaceutical and biotechnology companies, with 85 percent comprised of clinical segment, the global CRO market was estimated at $31.6 billion in 2018 and is expected...

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Marketing Authorization Procedure for Pharmaceuticals in Europe

Most of the processes to approve drugs in the EU are similar to those of the FDA, such as getting pre-authorization for use of the drug in clinical trials. After clinical trials, FDA drug approvals...

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