COVID 19

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Reflections on Covid-19 inbound supply chain issues

Reflections on Covid-19 inbound supply chain issues

LONG READReflections on Covid-19 inbound supply chain issuesCovid-19 has had a significant impact throughout the biopharmaceutical industry, not least on the inbound supply chain, which has been hit by issues such as restricted supplies, the need for new sourcing strategies and how to design and build new facilities.To assess the issues, major supply partners (MSPs) were invited to submit questions to the biomanufacturing members of the Senior...

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Defining technology strategy and leading innovation

Defining technology strategy and leading innovation

LONG READDefining technology strategy and leading innovationCelebrating five years of the biomanufacturing technology roadmap   Market growth, new product groups, cost pressure, and localized manufacturing trends are significant challenges faced by the biopharmaceutical industry. They are often too great for companies to tackle on their own.  To solve these challenges and lead the industry toward acceleration of technology creation and...

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The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements

The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements

Driving the harmonization of regulatory requirements – one country at a time  Regulations play a significant role in assessing marketing authorizations for drug products that are submitted for approval. Yet, regulatory agencies often differ in their degrees of harmonization. This has created an environment of divergence, in which countries each have unique standards, requirements, submissions and review processes.  The potential...

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Electronic Product Information

Electronic Product Information

Why we all stand to gain from harmonized electronic product information  Electronic product information (ePI) is gaining increasing interest from many national and regional regulators, and there is a genuine desire to develop ePI solutions that add value to patients and healthcare providers.  For example, EU legislators and regulators have published their views of the benefits of ePI to disseminate information and complement paper...

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How to master virtual inspections and audits – learning from experience

How to master virtual inspections and audits – learning from experience

In normal conditions, regulatory inspections and audits are conducted on-site, with inspectors viewing operations, talking to staff and reviewing documents to ensure they meet requirements. However, travel and social restrictions due to the Covid-19 pandemic have forced regulatory inspections and audits of affiliates to be conducted remotely. This is a very different way of working as it is much more difficult to view and explain process steps...

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How industry is reacting to the Covid-19 pandemic

LONG READHow industry is reacting to the Covid-19 pandemicKeeping in touch with peers and colleagues has never been more important. Following the postponement of meetings such as the annual Executive BioPhorum meeting, coupled with the heightened need for communication between industry leaders, BioPhorum established the Senior BioPhorum Connect – a group for senior leaders to share ideas, discuss problems and find solutions to counter the...

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How industry is meeting FDA expectations on the impact of COVID-19

How industry is meeting FDA expectations on the impact of COVID-19

In June 2020, the US FDA published Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing. It provides guidance for industry on the impact of the COVID-19 pandemic and on its expectations around good manufacturing practices (GMP). A cross-industry BioPhorum team – consisting of 130+ subject-matter experts across 43 member organizations – has now prepared a...

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How is industry responding to the covid-19 pandemic?

How is industry responding to the covid-19 pandemic?

During the covid-19 pandemic, it is even more important that we connect, share information and help each other meet the unique challenges faced by our industry. The Senior BioPhorum Connect group – consisting of the leaders and sponsors from the BioPhorum communities – has been meeting online since April to discuss and adapt their responses to the pandemic. To assess the measures taken across the industry, BioPhorum recently ran a covid-19...

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BioPhorum Connects senior leaders as they respond to COVID-19 crisis

BioPhorum Connects senior leaders as they respond to COVID-19 crisis

Keeping in touch with peers and colleagues has never been more important. Sharing ideas, discussing problems and finding solutions are vital to counter the extraordinary COVID-19 pandemic. For the leaders of development and manufacturing supply chains, the priority has been continuity of supply and workforce protection. The urgency of the situation has led to rapid decision-making, new policy approaches and innovation at a pace that is unusual...

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