Journal Articles related to Integrated Product Development
Journal Article
- July 27, 2023
Page 32 -Think of regulators as allies. They share the goal of bringing life changing medications to the patients that need them and are partners in development. Meetings with regulators should, therefore, not be seen as discussions to avoid or as hurdles to overcome but as opportunities for sharing critical information and gaining alignment
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
- 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 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
- August 26, 2022
With both the cost and time to bring a drug to market ballooning, the importance of an integrated product development (IPD) strategy is gaining traction. This multidisciplinary approach to drug development brings key stakeholders together, breaking down barriers to an e!cient and cost-e”ective path to market. But while more organisations are adopting an IPD strategy, a recent industry survey found most aren’t doing so early enough. Frédéric Pailloux, Senior Director, Head of Integrated Product Development and Consulting at PharmaLex examines the IPD journey.
Journal Article
- July 26, 2022
Biopharma companies are grasping the key role an integrated product development strategy can play in the drug development process. A recent industry survey found growing uptake of this multidisciplinary approach to improving efficiency and reducing costs and timelines, though the barriers to successful implementation were similar across the board.