Igniting Innovation in Development & Quality During Lifecycle Management
ISPE 2019 Global Pharmaceutical Regulatory Summit is entitled: Igniting Innovation in Development & Quality During Lifecycle Management
I think we would all agree that these are exciting times for the pharmaceutical industry.
- There is a revolution in the understanding of the biological bases of disease that is leading to the development of more effective and more targeted medications than previously possible.
- Engineering advancements are providing new and novel manufacturing technologies such as single-use bioreactors, continuous manufacturing systems, and 3D printing of dosage units.
- The sensitivity and separation capabilities of new and existing analytical techniques are pushing the boundaries of product characterization and material understanding.
- The field of drug-delivery devices is providing great opportunities for more convenient and better control of dosing medications through the development of novel combination products.
- Computational methods and computer-controlled systems are revolutionizing drug discovery, data analysis, decision-making, and manufacturing control.
Although I’ve listed these advancements as separate bullet-points, their real benefits are attained when they are applied synergistically to achieve better healthcare, higher quality medicines, and improved manufacturing efficiencies. In fact, the practical implementation of most of these advancements is dependent on their combined application during drug development, manufacturing, and quality assurance. For example, an effective continuous manufacturing process requires novel on-line analytical techniques to monitor quality during manufacturing and to provide data to computerized feedback-controlled processes.
Of course, before such new and innovative products and technologies can reach patients and healthcare providers, they must be rigorously evaluated by the regulators to ensure that the products are safe, effective, and of high quality. However, because the technological developments are continually on an accelerating trajectory, it is challenging for regulators and the industry’s regulatory affairs departments to adjust to these new applications with regard to an appropriate regulatory paradigm. Nonetheless, there is a dedication within the regulatory bodies and a drive within industry to bring better and higher quality medicines to patients as soon as possible. With these factors in mind, the International Society of Pharmaceutical Engineers (ISPE) has planned an FDA-Industry conference for December 5 & 6, 2019 at the North Bethesda Marriott Hotel in Bethesda Maryland for regulators and industry representatives to address the regulator successes and challenges presented by technological innovation in the pharmaceutical sector.
This year’s ISPE 2019 Global Pharmaceutical Regulatory Summit is entitled: Igniting Innovation in Development & Quality During Lifecycle Management. If you attend, you will hear leaders from regulatory agencies and industry speak on a wide range of topics including; Advanced Therapeutic Medicinal Products (ATMPs), Continuous Manufacturing, Setting Patient-Centric Specifications, Combination Products, Quality Metrics, and Pharma 4.0. Not only will you hear the latest developments in these and other areas, but there is ample time set aside during each topic’s session for attendees to get answers to their most burning questions from speakers.