Journal Articles
Journal Article
- May 30, 2023
Now that regulators, subject-matter experts (SMEs), and other stakeholders can observe and review facilities on site, we might wonder what purpose virtual audits serve and what benefits still could be leveraged.
Journal Article
- May 18, 2023
Shifting to a digital regulatory environment is forcing pharmaceutical companies to confront knowledge gaps across key research and development (R&D) functions.
Journal Article
- May 5, 2023
Effective change management systems ensure that innovation and continual improvement are facilitated, that change is appropriate and proportionate, and that key personnel take a level of ownership of the change. Processes related to change management must include an understanding of the current state and a vision for the future state.
Journal Article
- May 5, 2023
The fields of immunology and immuno-oncology have seen some significant advances and changes throughout the past decade or more, all of which are bringing new hope to patients and healthcare systems. In the next 5 years, these advances are expected to gather momentum amid new scientific and technological breakthroughs.
Journal Article
- April 5, 2023
PharmaLex was established 25 years ago with a vision to make a difference to how the industry interacts with regulatory authorities.
Journal Article
- April 5, 2023
Heightened interest in small molecules is likely to continue in 2023 and beyond as several biotech companies look beyond biologics to bring medicines to patients in need.
Journal Article
- March 27, 2023
The European Medicines Agency (EMA) was true to its word in 2022. While pharmaceutical companies involved in manufacturing sterile products were assessing the text of Draft Revision 12 of Annex 1 to the European Union’s good manufacturing practice (GMP) regulations, the final approved revision was published on 25 August 2022 (1), bringing an end to speculations about what it would include.
Journal Article
- March 23, 2023
Efforts to build greater harmonization between global regulators are gathering momentum, partly due to changes brought about by COVID. This growing trend is likely to continue as regulatory authorities gain increasing confidence in collaborative initiatives that are still in their infancy.
Journal Article
- March 15, 2023
The demands on life sciences companies are constantly intensifying. Resource constraints – whether workforce or the need to cut costs or streamline processes – different global regulatory requirements and the need to stay on top of technology advances create an increasingly complex environment for the industry.
Journal Article
- March 8, 2023
The Life Science Sector has been undergoing an immense transformation, driven by the adoption of artificial intelligence (AI), machine learning (ML), natural language processing (NLP), and big data.
Journal Article
- March 3, 2023
Companies in the life sciences industry must ensure they have the systems and tools to be able to consistently provide a product that is safe and effective and that is delivered in a timely manner to meet the needs of customers, in addition to an efficient and agile support system for resolution of unexpected situations.
Journal Article
- February 28, 2023
Even though this is true in any business sector, it is particularly important for companies in the life sciences industry, where personnel must deal with many complex processes in a highly regulated environment to ensure both product and operations are compliant.