MEDICAL WRITING AND REGULATORY AFFAIRS CONSULTING

    Orphan diseases, also known as rare diseases, represent a diverse group of medical conditions that individually affect a limited number of individuals within a population. Despite their rarity, the cumulative impact of orphan diseases is substantial, as they collectively affect millions of people worldwide. This article explores the challenges associated with orphan diseases, including limited research, diagnostic difficulties, and therapeutic development hurdles. Additionally, it highlights recent advances in the field, such as the emergence of precision medicine and collaborative efforts, which provide hope for improved understanding, diagnosis, and treatment of these often neglected conditions. Introduction  Orphan diseases: defining rarity and significance Epidemiology and global burden Challenges in Orphan Disease  Research Limited knowledge and understanding Diagnostic delays and difficulties Heterogeneity and personalized approaches Lack of funding and resources Regulatory c

  Brown spots, also known as hyperpigmentation, are a common skin condition characterized by areas of the skin that are darker than the surrounding skin. They can be caused by excessive sun exposure, skin aging, hormonal fluctuations, inflammatory reactions, or other factors. Here are some solutions that can help reduce brown spots: Sun protection: The first step in reducing brown spots is to protect your skin from harmful UV rays from the sun. Use a broad-spectrum sunscreen with an SPF of at least 30 and reapply every two hours, especially if you are outdoors. Lightening agents: Certain lightening ingredients can be used to reduce the appearance of brown spots. Examples of commonly used lightening agents include kojic acid, azelaic acid, glycolic acid, vitamin C, hydroquinone (to be used with caution), and retinoic acid. It is recommended to consult a dermatologist to determine the best products for your skin. Laser treatments: Laser treatments can be effective in reducing brown spots

Medical artificial intelligence (AI) Medical artificial intelligence (AI) refers to the application of AI technologies in the field of healthcare and medicine. It involves the use of algorithms and machine learning techniques to analyze medical data, make predictions, assist in diagnosis, recommend treatment plans, and improve overall patient care. Medical AI has the potential to revolutionize healthcare by augmenting human capabilities, enhancing accuracy, and improving efficiency in various medical tasks. Here are some areas where medical AI is being utilized: Medical Imaging: AI algorithms can analyze medical images such as X-rays, CT scans, MRIs, and mammograms to detect abnormalities, assist in diagnosis, and aid in early disease detection. These algorithms can help radiologists by highlighting potential areas of concern and prioritizing cases for review. Diagnostics and Decision Support: AI systems can analyze patient data, including medical records, lab results, and symptom

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems associated with pharmaceutical products. It involves the continuous monitoring and evaluation of the safety and effectiveness of medications once they are on the market. The primary goal of pharmacovigilance is to ensure patient safety by identifying and managing the risks associated with the use of medications. It plays a crucial role in collecting and analyzing data on adverse drug reactions (ADRs), which are any harmful or unintended reactions caused by the use of medications. This information is used to identify potential safety concerns, take appropriate regulatory actions, and communicate the risks and benefits of medications to healthcare professionals and the general public. Pharmacovigilance activities typically include: Adverse Event Reporting: Healthcare professionals, patients, and other stakeholders are en

  Lung cance r   :  Place of biosimilars in the therapeutic arsenal .   According to the WHO, lung cancer is one of the 5 most common cancers in the world. World (1). It requires heavy multidisciplinary  care and is the source of significant expenditure, which thus constitutes a real public health problem either at the international level or in developing countries such as Morocco. Lung cancer usually starts in the cells that line the bronchi and parts of  the lung like the bronchioles or alveoli. There are two main types of primary lung cancer (2): • Small cell lung cancer (SCLC): this type takes its name from the small cells that compose it and which are visible under a microscope. • Non-small cell lung ca ncer (NSCLC): this is the most common type of lung cancer, accounting for 85-90% of all lung cancers.   In 2018, the number of new cases of lung cancer diagnosed worldwide was estimated at more than 470,000 (2) To reach more than 19,000,000 in 2020 (see Figu re 1) for both sexes, w

SAFETY OF  BACILLUS SUBTILIS   AS PROBIOTIC /ORAL USE   SYSTEMATIC LITERATURE SEARCH Different steps   below are   followed to  gather all documents related to the substance of Bacillus subtilis as oral supplement food  probiotic: •  Documents identified through database  •  Documents screened based on titles •  Ful text articles assessed for eligibility •  Studies included in the systematic review •  Some documents were excluded based on French language and other based on species different to Bacillus subtilis. History and pattern  and  human use  Use in therapeutic goods (Australian and International ) Australia and New Zealand have no specific regulations on probiotics, nor a definition of probiotics. Microorganisms, including probiotics, are considered novel foods according to FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON NUTRITION AND FOODS FOR HEALTH OR  DIET. Brazil, Colombia and Ecuador have adopted a definition of probiotics that is aligned with the definition proposed b