Journal Articles related to Innovations to Market
Journal Article
- July 24, 2023
Pages 14 – 15. Change management offers a broad, system-wide perspective that includes the oversight and management of all changes and the change process. Michelle Anastasi from PharmaLex explores what good change management looks like and who should be involved.
Journal Article
- July 5, 2023
Pharmaceutical legislation usually describes GxP requirements broadly. Additional regulations, directives, ordinances, and guidelines may provide further guidance for interpretation and implementation, but each organization is unique. Companies differ according to their location, size, facilities, personnel, products, and business activities. affairs department of a pharmaceutical company. As usual, I attended onboarding meetings and received a training plan that contained a list of standard operating procedures (SOPs). So far, so good.
Journal Article
- June 22, 2023
Change management is integral to ensuring appropriate implementation and maintenance practices for pharmaceutical quality systems (PQS). 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 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
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 12, 2023
An agreement reached by the UK and EU regarding the Windsor Framework brings changes to the Northern Ireland regulatory landscape. The agreement , in principle, was reached on February 27, 2023.
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 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
- July 21, 2020
PharmaLex.pert Limaris Alvarado discusses the complexities of product launch and the importance of effective planning, efficient manufacturing process, technical capability, regulatory strategy, and committed launch date strategy.