Important industry news and company updates
Learn About the Latest Updates of the GMP Guidelines
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Published - 06.Jan.2017

The manufacturing environment and regulatory setting in Pharma are changing. There is a continuous adoption of new approaches when it comes to Good Manufacturing Practice (GMP) by researchers and other practitioners. Progressive technologies are coming into play as well, in attempt to streamline the landscape of drug manufacturing, the Clinical industry, the Research sector and healthcare in general. Consequently, clinging on to outdated requirements which do not apply to the current state of all of those fields becomes a practice...MORE >

What is the importance of Good Laboratory Practice?
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Published - 27.Dec.2016

The term Good Laboratory Practice or GLP was first introduced in 1970’s in Denmark and New Zealand. Soon after that, it was used by the Federal Drug Administration (FDA) and the Organisation for Economic Co-operation and Development (OECD), referring to a quality system of regulation and management practices or requirements in research laboratories. Good Laboratory Practice embodies different principles which are designed to ensure and promote consistency, quality, safety, reliability and integrity of chemicals during non-clinical and laboratory testing. Nevertheless,...MORE >

Good Manufacturing Practice in Pharma: Importance and Training Courses
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Published - 12.Dec.2016

Poor quality pharmaceuticals and similar medical products pose great risks to patients and healthcare in general. On top of turning into a waste of time, effort and resources, in the end, they cannot deliver the intended treatment results and therapeutic effect. The main reason behind products’ inefficacy and hazardous nature is insufficient or uncontrolled manufacturing environment. In this regard, in order to prevent risks of infections, complications, degradation of medicine, cross-contamination or other negative impact before during and after production,...MORE >

Astra Nova is Launching a Christmas Campaign in December
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Published - 05.Dec.2016

As an industry leading training and certification provider, Astra Nova provides bespoke online training programs, in-house training solutions, webinars and a number of free courses suitable for Clinical Research Organisations, Pharmaceutical companies and other institutions in the field of Biotechnology. With the new year just around the corner, we are now launching a Christmas campaign which delivers great offers and discounts on all of our individual and corporate certification courses. Gaining in-depth knowledge on ethics, regulatory requirements, guidelines, good practices, audits, informed consent, drug...MORE >

What is Quality Assurance in Clinical Trials?
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Published - 29.Nov.2016

There are plenty of factors which affect the clinical trial landscape. Sometimes it could be due to unpredicted patients’ behavior or reactions, while performing a study. Newly introduced guidelines which require immediate action different from pre-set processes are able to alter how Pharma is unfolding as well. Technological advancements can also dictate major changes. Developments and tech-driven practices, tools, methods and trends such as implementing electronic data capture, m-health or cloud computing are all forces which impact the research industry...MORE >

The Importance of Risk Management in Clinical Trials
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Published - 22.Nov.2016

Pharmaceutical companies and clinical study organizations recognize Quality Assurance (QA) and Quality Control (QC) as extremely vital. They are critical not only to drug development and other related research processes but to patients’ safety as well. In this regard, sustaining quality, precision and compliance is a way to guarantee that pharmaceuticals and medicinal products are safe to use, while human subjects are protected from various trial risks. Therefore, sponsors who are responsible for Quality Assurance and Quality Controll utilize a...MORE >

Cloud Computing in Pharma: What are the benefits?
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Published - 15.Nov.2016

Pharma is known as the industry which is slower in adopting ground-breaking technologies than other fields or businesses. It is true that there is a noticeable progress, and various examples of advanced technological use can be noted. And yet, companies take into account the possibility of risks and disadvantages that may arise. Slowly but surely, though, plenty of revolutionary methods are being deployed in clinics and research centers, enabling researchers and industry leaders to optimize their practices and related procedures....MORE >

Case-control studies: What exactly are they?
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Published - 09.Nov.2016

People usually learn about clinical studies, results, projects, cases and other relevant topics by reading online sources or through social media. And while they pay attention on the content, they rarely focus on the design of the study itself. Even though it may seem as something irrelevant, it is, in fact, very crucial to the understanding of the results, findings of the trial and their quality. And when it comes to findings and evidence, the most reliable ones are proven...MORE >

Under-reporting of Adverse Drug Effects in Clinical Research
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Published - 31.Oct.2016

Reporting of adverse drug effects (ADE) represents one of the very crucial aspects in clinical research. Appropriate documentation and sufficient information about any such effect or reaction can make a huge difference in terms of patients’ safety and quality of pharmaceuticals which have been tested, manufactured and approved for general consumption. Being reported in online medical articles and other recourses, adverse events (or side effects which are regularly collected in randomized clinical trials) can help caregivers, practitioners, patients, reviewers and...MORE >

Cross-contamination in Pharmaceutical Manufacturing: Why is it so dangerous?
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Published - 24.Oct.2016

Cross-contamination in pharmaceutical manufacturing has become a huge concern not only to experts involved in the therapeutic market and pharma industry as a whole, but to the average person as well. It becomes a major topic of discussion among various communities. But what exactly is this? In essence, that is the ‘infection’, so to speak, of any material in process (starting material or intermediate product) or a finished drug with another material in process or pharmaceutical. It is critical for...MORE >

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