Regulatory submissions are a cornerstone of the pharmaceutical industry, and mastering this process is essential for regulatory affairs professionals. On November 8, 2024, AAPS hosted an insightful webinar on Drug Product Submission (NDS) Preparation in eCTD format. The webinar aims to equip participants with practical knowledge and skills for successful submissions. Here are the four key takeaways from this dynamic event. 1. Understanding the Importance of the Common Technical Document (CTD) One of the standout segments of the webinar focused on the Common Technical Document (CTD), a globally standardized format for regulatory submissions. Participants learned how the CTD facilitates organization.. READ MORE »
Regulatory affairs in the pharmaceutical industry ensure that products comply with all regulatory laws and guidelines relevant to pharmaceutical and medical products. With the expansion of the pharmaceutical industry, there is a growing demand for skilled and well-trained professionals to fill diverse roles within this sector. This surge in demand reflects the industry’s ongoing development and its need for a wide range of expertise to sustain and enhance its growth. Are you a budding industry professional looking to contribute to safeguarding public health? Suppose you’re looking for a rewarding and stable role in regulatory affairs that allows you to leverage.. READ MORE »
Are you contemplating a career in regulatory affairs within the pharmaceutical industry? This sector is instrumental in developing, producing, and distributing medical drugs across the globe. One of the key aspects you’ll encounter is the creation and implementation of global regulatory strategies. These strategies play a key role in ensuring that new drugs navigate the intricate web of compliance and reach consumers safely and effectively. This blog post introduces global regulatory strategies and why they’re vital in today’s dynamic pharmaceutical landscape. Why Global Regulatory Strategies Matter Regulatory affairs training students know that borders do not bind the pharmaceutical industry. It.. READ MORE »
Are you looking for a way to increase your earning potential, advance your career, and expand your knowledge but need a way that fits into a full-time program’s financial or time commitments? An online regulatory affairs diploma is the tailored solution you need. Our online regulatory affairs diploma program offers the flexibility to balance study with other responsibilities, enabling you to earn a reputable qualification at your own pace and from the comfort of your home. With its combination of flexibility, comprehensive learning, and career prospects, it’s an investment that promises significant returns. Regulatory Affairs (RA) is a critical function.. READ MORE »
Document control refers to the systematic management of documents from inception to disposal. This process prioritizes the accuracy, comprehensiveness, accessibility, and protection of these documents to align with regulatory mandates, quality benchmarks, and functional requirements. Document controllers oversee the prompt and efficient preparation and handling of documents. They manage the organization, numbering, archiving, and retrieval of both electronic and paper-based documents produced within a company. As global markets become more intricate and the web of regulatory stipulations expands, the importance of document control becomes even more pronounced. Here are four reasons why mastering document control is paramount after completing your.. READ MORE »
Regulatory affairs officers play a vital role in ensuring that various products, including foods, cosmetics, pharmaceuticals, and veterinary medicines, comply with legislative requirements throughout their development, testing, and marketing processes. In other words, they navigate the complex landscape of regulatory requirements and help bring products to market smoothly. The Quality Assurance and Regulatory Affairs program at AAPS can equip budding regulatory affairs professionals with all the training necessary for a career in the industry. However, success as a regulatory affairs associate also relies on a diverse skill set encompassing technical and non-technical abilities. Technical skills such as regulatory knowledge and.. READ MORE »
Regulatory approval is an essential stop in the journey from drug/product discovery to development and market launch. This informs the need for a rigorous regulatory affairs documentation process to ensure the correct information is accounted for. The work of regulatory affairs document reviewers requires them to possess several critical skills to function optimally. While these skills come naturally to some, they can be acquired through the right regulatory affairs training. Here, we discuss a few of the most important skills needed to carry out regulatory affairs document reviews successfully. What Does a Regulatory Affairs Document Review Entail A regulatory affairs.. READ MORE »
The cosmetic industry is a booming global industry worth billions of dollars, with an extensive range of products, including makeup, skincare, fragrances, and hair care. According to Statista, there are over 2500 cosmetics stores in the country, and the Canadian cosmetics market is expected to grow to roughly 1.7 billion dollars by 2027. Having said that, regulating cosmetic products is a complicated process, with several regional and international regulatory bodies enforcing strict rules and guidelines to ensure product safety and efficacy. These guidelines ensure that companies comply with regulations and standards, and regulatory affairs professionals have been tasked with enforcing.. READ MORE »
As we celebrate International Women’s Day, the Academy of Applied Pharmaceutical Sciences (AAPS) would like to take a moment to honor and recognize the countless contributions made by women in the field of pharmaceuticals. Pharmaceuticals play a critical role in maintaining and improving our health, and women have been instrumental in advancing this field. From developing new medications to conducting clinical trials and ensuring drug safety, women have played a key role in every aspect of pharmaceuticals. At AAPS, we are proud to have many talented women as part of our faculty, staff, and student body. These women bring a.. READ MORE »
The future of work is being shaped by a variety of trends and developments that are transforming the way we work, including: Trends and Developments Remote work: The COVID-19 pandemic has accelerated the trend toward remote work, and many experts believe that it will become more widespread in the future as technology continues to improve. Automation: Advances in automation and artificial intelligence are leading to the automation of many jobs, which could result in the displacement of some workers but also the creation of new types of jobs. Gig economy: The gig economy, which refers to a labor market characterized.. READ MORE »
