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Drugmakers pledge shorter launch times for drugs in EU

pharmaphorum

Pharmaceutical companies have said they will try to carve months off the time between approval and launch for new medicines in Europe, and reduce disparities between access between countries. — EFPIA (@EFPIA) April 11, 2022. ” The post Drugmakers pledge shorter launch times for drugs in EU appeared first on.

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Time to change the channel? The future for customer engagement models

pharmaphorum

The pandemic has triggered a change in how pharmaceutical companies are engaging with healthcare professionals. When IQVIA polled non COVID-19 treating Italian HCPs in March when the crisis was at its worst, it asked HCPs if they still welcomed pharmaceutical company engagement during the crisis. The answer was yes.

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2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients

ISPE

QMM encompasses a range of actions including metrics, leadership commitment, culture, sustainable compliance, enhanced pharmaceutical quality systems, continual improvement, and risk management. QMM rating program is necessary to ensure patients have consistent access to the drugs they need. Next Slide ??. Michael Kopcha. Thomas Wozniewski.

FDA 98
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A Systemwide Approach to Managing the Risks of Continuous Manufacturing

ISPE

One of the most important components of SRM is the company’s risk appetite statement. This document is approved by the firm’s board of directors and sets the tone for risk-taking at the company by key risks and setting risk tolerances for how much risk the board is willing to take across all business activities. March 2023.

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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. Journal of Pharmaceutical Sciences 104, no. White Paper on Continuous Bioprocessing.”

FDA 52
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How to choose the right antimicrobial agent for a new pharmaceutical formulation

Pharmaceutical Technology

In addition, several pieces of documentation will be required to support the API qualification, e.g. pharmacopeial compliance. It is also essential to evaluate the reliability of the company supplying the ingredient: do they provide sufficient communication and documentation? Is Benzalkonium Chloride a good choice?