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...
View ArticlePsoriasis – 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...
View ArticleHong 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...
View ArticleClinical 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...
View ArticleComplicated 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...
View ArticleNew 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....
View ArticleSri 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,...
View ArticleClinical 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...
View ArticleClinical 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...
View ArticleRare 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...
View ArticleRare 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...
View ArticleRare 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...
View ArticleRare 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...
View ArticleClinical 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...
View ArticleRare 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...
View ArticleRare 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...
View ArticleRare 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,...
View ArticleRare 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....
View ArticleHow 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...
View ArticleMarketing 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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