AI is the new buzzword, and it does not seem like its buzz is getting any fainter any time soon. We all know that Artificial Intelligence (AI) and Machine Learning (ML) have been a transformative force across various industries, and the medical sector is no exception. In recent years, AI/ML has made significant strides in revolutionizing Regulatory operations within the medical industry.
- September 21, 2023 Regulatory Software & Services
The development and approval of medications for children is a critical aspect of pediatric healthcare. However, due to ethical and practical considerations, clinical trials involving children are often limited. As a result, pediatric drug labeling plays a crucial role in ensuring the safe and appropriate use of medications in this vulnerable population.
Quality is paramount in the pharmaceutical industry. From research and development to manufacturing and distribution, every step must adhere to the highest standards of accuracy to ensure patient safety and Regulatory compliance. One of the major aspects of this intricate process is pharmaceutical labeling, specifically the artwork flow.
In the highly regulated pharmaceutical industry, the production of medicines and related products requires meticulous attention to detail and compliance with various regulatory guidelines. One critical aspect of pharmaceutical production is creating, approving, and managing artwork, including labels, packaging, and promotional materials.
- September 20, 2023 Publishing & Submissions
The ever-evolving Regulatory landscape demands businesses to adapt swiftly to new submission formats. Converting legacy data to meet these requirements in real time presents a complex and multifaceted challenge. It is in the best interest of the organizations to be able to convert their legacy data quickly and efficiently to new formats to comply. This can be a complex and challenging task, especially in real-time.
The Clinical Trials Information System (CTIS) is a centralized database that supports the conduct of clinical trials in the European Union (EU). It was launched in January 2022 and is a key component of the Clinical Trials Regulation (CTR), which aims to improve the efficiency and transparency of clinical trials in the EU.
Regulatory publishing involves a complex web of Country-specific health authority requirements that must be met before any product can be commercialized. The documentation includes clinical trial data, safety data, manufacturing processes, and labeling information, among other things.
The pharmaceutical industry plays a crucial role in ensuring the well-being and health of people worldwide. In this highly regulated sector, packaging plays an essential role in maintaining the safety, efficacy, and integrity of pharmaceutical products. Pharmaceutical packaging is a complex and highly regulated industry.
China has been gradually adopting eCTD submissions since 2017. In 2022, the National Medical Products Administration (NMPA) announced that it would be fully transitioning to eCTD submissions by the end of 2023. This means that all new drug applications submitted to the NMPA must be in the eCTD format.
In the pharmaceutical industry, ensuring patient safety is paramount. As new medications are developed and introduced into the market, it becomes crucial to provide accurate and comprehensive information to healthcare professionals and patients. This is where labeling and pharmacovigilance play a pivotal role.