With upcoming changes, including the implementation of the International Conference on Harmonisation (ICH) E2B(R3) Electronic Transmission of Individual Case Safety Report and Identification of Medicinal Products (IDMP) standards, the current state of safety reporting can be confusing. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets regarding the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.
Because a key step towards database lock is obtaining clean data for all patients, the ability to verify that data are clean early accelerates the ability to lock the clinical database. This ultimately shortens the overall study timeline while ensuring the quality of your data. However, this can be challenging when manually reviewing study data, particularly with larger studies.
Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.
This paper presents highlights from a thermal performance study conducted by Modality Solutions LLC. The study examined the performance of five shipping technologies commonly used by specialty pharmacies to transport high-value refrigerated specialty medicines against an industry accepted temperature profile standard.
The specialty pharmacy industry could reduce costs by $27.5 million annually (product and call center staff costs only) if visual temperature indicators were used as decision-making tools to determine if medicine should be used or returned when patients suspect heat damage. In addition, 97% of patients surveyed, who received medicine from specialty pharmacies with a visual temperature indicator included in the package, agree that they would want an indicator in all shipments and 95% agree the indicator increased their confidence in the medicines received.
PCI Pharma Services has invested in state-of-the-art containment equipment and created a ‘Potent Passport’ philosophy to identify the specific handling requirements for any Highly Potent Active Pharmaceutical Ingredients (HPAPI) project. Backed by 30 years’ experience of managing potent molecules, PCI Pharma Services is the logical choice when selecting an outsourcing partner.
The life sciences industry is changing at a rapid pace. The need to develop the next blockbuster is pushing current technologies and methodologies to the limit. Scientific advancement over the last decades was embossed with giant leaps in knowledge, however, the new reality is that smaller incremental gains need to be carved out with ever increasing investments. In order to survive, progress and prosper in this new reality, a holistic approach to getting the most of research data is crucial. In fact, it will likely be the difference of being in existence in 5-10 years or not. For those bold enough to step into an area they are unfamiliar with, huge rewards are waiting.
To patients and consumers, tablets are a simple and convenient dosage form. But the science behind compressing a block of particles or granules into a single tablet can be complicated. That’s where common compression studies can help. This article explains how to develop tabletability, compactibility, and compressibility profiles.
RWS Life Sciences welcomes Clarice Streets, ASQ, CMQ, OE, as Vice
President, Global Quality and Process, in charge of the strategic
direction and implementation of its Quality system, underlying
organizational processes, and change management. More info >>
Pharmaceutical Packaging and Device Labelling Europe
11-12 September 2018, Munich, Germany
Relaunching
the event after a three year hiatus, Pharma Packaging and Labelling Europe is
back to deliver key, actionable insight on the very latest regulatory
requirements, technological innovations, strategic developments, and how to
implement them into your packaging and labelling chain with both maximum
efficiency and minimal cost. The conference is packed with thought provoking
innovative discussions. More info >>
