Jury refers to a body of able persons who have sworn to deliver a verdict on a matter submitted to them. They take the evidence into check and make sound judgements pertaining to a case. A jury is expected to be a fair and unbiased body.
This is a provision/ clause in the insurance policy. According to it, the insurance company will not be obliged to pay the insured with the premium in case they are seriously injured, the degree of injury varying in the definition of disability.
What is the Therapeutic Goods Administration? TGA, or Therapeutic Goods Administration, is the regulatory authority of Australia for therapeutic goods, including prescription medicines, medical devices, and vaccines, among others. The TGA carries out several assessments along with monitoring activities to make sure that therapeutic goods that are available in the country are of an acceptable standard. The Therapeutic Goods Administration was formed in 1989 under the jurisdiction of Commonwealth of Australia. What do therapeutic goods include? A therapeutic good or product is a broad term used for products that are meant to be applied in or on humans for any therapeutic reason. For instance, therapeutic purposes comprise bringing a physiological response for prevention, diagnosis, monitoring, alleviation, cure, or treatment of a disease, defect, ailment, or injury. What is the structure of TGA? In the Australian Government Department of Health, the TGA is part of the Health Products Regulation Group (HPRG). The HPRG includes the TGA and the ODC (Office of Drug Control). Medicines Regulation Division of the TGA evaluates applications to authorise new medicines for supply in Australia. Medicines regulation division is also accountable for monitoring drugs or therapeutic products approved for distribution in the country once they are on the market. This division includes- Prescription Medicines Authorisation- This section is responsible for evaluating new prescription medications, that lead to a decision of approval or rejection. Complementary and Over-the-counter (OTC) Medicines- Responsible for regulating over the counter medicines as well as complementary medicines, which include traditional and herbal medicines, and vitamin and mineral supplements. Scientific Evaluation- Accountable for approving applications to market biologicals and generic medicines in Australia. Pharmacovigilance and Special Access Branch- This branch supervise medicines & vaccines to make sure that they maintain a suitable level of quality, safety, and efficacy after entry into the Australian marketplace. This branch also assesses some clinical trials and special access arrangements for all types of therapeutic formulations. Medical Devices and Product Quality Division of the TGA monitors medical devices that are approved for supply in the country and functions to make sure that Australian as well as international therapeutic goods producers meet specified standards. This division includes- Medical devices branch, which is responsible for evaluating medical devices, including in-vitro diagnostic tests, and monitoring them throughout their lifecycle to ensure they continue to meet an appropriate level of quality, safety, and performance. Laboratories branch is accountable for conducting laboratory testing, quality assessment and test procedure development in scientific disciplines like molecular biology, microbiology, immunobiology, chemistry, biochemistry, and biomaterials engineering. Moreover, the laboratories branch also contributes to post-market monitoring and the evaluation of a range of therapeutic products for market authorisation of drug. Manufacturing quality branch guarantees that manufacturers engaged in the production of medicines, along with tissue, blood, and cellular therapies, meet the required quality standards. Regulatory Practice and Support Division offers operational, regulatory policy guidance as well as specific support facilities to make sure effective, best practice regulatory processes to the HPRG. The branches of this division include- Regulatory services and drug control branch are responsible for the Program Office of TGA, management of enquiry via the regulatory assistance division, activity-based pricing & billing, business systems help-desk, along with the coordination of internal assessments of regulatory decisions. Regulatory education and compliance branch look after regulatory compliance activities, including education, advertising, enforcement, and investigations into illegal and counterfeit therapeutic goods. Regulatory engagement and planning branch is accountable for managing engagement of shareholder with international regulators, regulatory guidance material, planning & performance reporting, media responses, coordination of technical input for Freedom of Information requests and committee support. What is the role of the TGA? The TGA monitors the ongoing benefits and risks of therapeutic goods once they are authorised for application. Moreover, the agency can take any action if the benefits are not realised, or additional risks become noticeable. The probable regulatory measures are distinct from minimal intervention, like labelling modifications, to withdrawing the therapeutic good from the market. The TGA manages an overall control via the following main processes- Pre-market evaluation as well as approval of registered products aimed for distribution in Australia. Development, maintenance, and monitoring of the system for registering any new therapeutic product. Licencing of producers in agreement with global standards of the good manufacturing practices (GMPs). Post-marketing monitoring via sampling, reporting of adverse events, surveillance activities as well as response to public enquiries. Assessment/review of medicine for its import and export. Moreover, the TGA regulates the supply of- Risk management approach of the TGA to regulate therapeutic goods The Therapeutic Goods Administration is responsible for making sure that the therapeutic goods accessible for supply in Australia are safe and appropriate for their expected objective. These include therapeutic goods Australians depend on every day, like sunscreens & vitamins through to medicines to treat severe diseases including prescription medicines, surgical implants, vaccines, and blood products. In quintessence, this means that the agency- Identifies, reviews, and assesses the risks caused by any therapeutic goods. Applies any necessary measures for treating the risks caused by a therapeutic good. Monitors and analyses the risks over time. Therapeutic goods are not free of risks completely, and the associated risks could be mild, moderate, or severe. The function of the agency is based on applying scientific along with some clinical expertise to make any decision. By this way, the agency ensures that the benefits to users outweigh any risks associated with the use of a specific therapeutic product, medical devices, or any other medicine. For instance, some blood pressure medications might have some side effects, such as persistent cough or throat tickle. However, the associated risks by blood pressure medicine are outweighed by the advantages of lowering the chances of a stroke or heart attack. Moreover, the risk-benefit approach ensures that the medicine or products the users take are safe for their intended purpose, while still giving access to products that play an essential role in health needs. The Therapeutic Goods Administration works closely with consumers, health professionals, industry along with international counterpart to ensure the safety of any therapeutic product or medicine.
What is MedTech? MedTech or medical technology helps medical professionals saves millions of lives. Medical technology comprises a wide range of products used in the healthcare sector. In today's healthcare scenario, almost every aspect is reliant on technology. Technology significantly amps up the quality of healthcare. One of the most common usage of medical technology is seen in diagnostics where medical conditions are identified to assist in treating humans. With one scan of the entire body, the machine can suggest which areas need improvement for doctors to chalk out the best course of action. It has also minimised hospital stays as the turnaround time of these technologies has improved. The recent focus on medical technology is also because of its cost effectiveness. Image Source: MegapixlTM Why is MedTech an integral part of the healthcare system? MedTech plays a vital role in our lives, that starts even before we are born (pregnancy tests, ultrasound scans, etc.) From not feeling well to getting a diagnosis to getting the help of medical devices for treatment, we turn to medical technology at every step. Everything that falls under the umbrella of technology in the medical field can be counted as MedTech. Be it healthcare information technology, diagnostic devices, biotech, or healthcare services; MedTech comprises it all. Its application lies in: Prevention of ailments by detecting diseases early through early detection tools Diagnosis of diseases or health conditions though scanning and in vitro diagnostic tests Monitoring or checking patient condition in hospital or at home and prevent further deterioration of health. In fact, MedTech helps in expediting recovery process. Medtech includes: Medical devices that help in diagnosis, investigation, prevention, replacement, monitoring, treatment, or mitigation of disease/ injury or making variations in the anatomy. in vitro diagnostic tests that assist healthcare professionals in collating tests results and making sound healthcare decisions. Digital healthcare that includes devices, kits, and services that utilise data technologies to enhance health condition of a patient through prevention, diagnosis, treatment, and monitoring. Image Source: MegapixlTM What are the benefits of medical technology? Medical technology has been revolutionary and many diseases which were not curable a few years back are in the safe zone due to medical technology. The technology is continuously changing the landscape of the healthcare industry. The industry is also witnessing the incorporation of big data and machine learning applications for a better patient outcome. MedTech companies are becoming an essential part of the ecosystem and aids in economic growth and job creation. Through technology, the industry is delivering value to not just patients but also to healthcare professionals, the overall system and the society by large. Benefits include: Well-timed and correct diagnostic report allows healthcare professionals to make sound clinical decisions that improves patient outcomes. MedTech helps in lessening patient recovery times and complication rates The MedTech sector takes off pressure from the healthcare professionals and make the system more efficient. The widespread use can provide accurate and faster diagnosis and improve outcome. Appropriate use of MedTech can be useful and safer while providing the treatment. The industry has enormous potential to grow, which is expected to save lives and reduce cost and time.
What is HSE? Why is it important for the energy industry? HSE or Health, Safety & Environment is an integrated approach to identify the potential hazards and take precautionary and preventive measures to mitigate any potential incidents' risks. HSE involves multidisciplinary functions to come together to avert or manage accidents and hazards. The energy industry, particularly the petroleum industry, is prone to accidents due to its job nature. The equipment and machinery involved in the operations are enormous and can inflict serious injury. The world has often witnessed crude oil oozing out from wells uncontrolled and causing severe environmental issues. Image source: johnkwan, Megapixl.com The accidents do not only impact human lives but could also damage the natural ecosystem of the area. A proactive approach towards sound HSE management could diminish the probabilities of such accidents or incidents. The proper implementation of the HSE management could lower the severity of the incidents. How is HSE implemented in the workplace? The hazards and their severity are different in various industries. An oil leak from a well could damage the surrounding ecosystem, whereas any malfunction in the heavy equipment could even lead to amputations or loss of life instantaneously. So, the companies chalk out their HSE policy based on the kind of risk their job poses and develop a system to manage the HSE challenges. The policies are written and made available to every employee for its implementation. The HSE policy must reflect the organisation's values and commitment towards employees, clients, and other stakeholders. What are the key aspects of the HSE policy in the resource industry? Key aspects of HSE policy can be listed as below: Safety of personnel and the environment is paramount and supersedes the production targets. Safety and environmental protection is the responsibility of every individual. Special training and induction should be given to each individual involved in the fieldwork. The organisation should provide proper personal protective equipment (PPE) to all its employees. All employees should be updated with the latest regulatory norms and codes. All incidents and accidents have to be duly reported, and a record should be maintained for the same. Only trained personals should be allowed to work in confined environments. A proper permit system should be there for performing hot jobs (welding). The above points are general in nature and should be modified based on the State or country's work environment and regulations. Define hazard, incident and accident. The three terms are interlinked with each other. Hazard is a source or process that can cause harm or injury to the person engaged in the process or could lead to damage to the machinery and environment or a combination of all these. Incidents are the events that can lead to accidents or have the potential to advance to accidents. The basic difference between hazard and incident is that incident is unplanned and had caused accidents in the past. If the operator identifies the faulting braking system during a routine check and rectifies it, then it is a hazard. If the same operator, while driving the hauling truck with loaded materials, finds out that the braking system is not working, then the situation turns into an incident. An accident is an event that can cause injury or damage to the machinery or the environment. From the above example, the truck loses control and could cause accidents that can spill the loaded material in the surroundings, cause injury to the operator and people at the spot of the accident. The mismatch of the three M's- Men, Material, and Method is always at the core of any accident. In any of three cases, hazard, incident or an accident, events should be reported properly, and a record should be maintained to avert such circumstances in the future. Case Study Deepwater Horizon accident in the Gulf of Mexico The Deepwater Horizon accident in the Gulf of Mexico is the biggest oil spill accident that the world has witnessed so far. The rig Deepwater Horizon was operating on the BP's Macondo Prospect in the year 2010 when a sudden blow out triggered a massive fire on the rig resulting in the death of 11 people. The oil well flowed non-stop for 87 days, leaking around 3-4 million barrels of oil in the sea. The various investigation pointed out the human error in gauging the outcome of the possible short-cuts the BP took to complete the delayed project. The cement that was supposed to fix the casing was not done placed properly, and BP ignored the good logging operations done to check and evaluate the cement job. Further, the blow out preventer (BOP) that was supposed to contain the hydrocarbon in the well did not work. People involved in cleaning the seacoast after the spill (Image source: Kajornyot, Megapixl.com The huge pressure of the oil threw the drill pipes out from the well and caused an explosion on the rig, which resulted in an extensive fire. The specialist from around the world tried continuously to control the well but was finally done on the 87th day of the accident. The impact of the spill was enormous on the marine and local environment. Thousands of birds, fish and marine creatures died. The entire fishing industry was finished in the region, and beaches became inhabitable due to the assemblage of a huge quantity of crude oil. BP had to pay US$65 billion in penalties and compensations. The accident could have been averted if the proper implementation of the HSE policy was ensured.