New European Focus on Medicine Supply Chains Means More Disclosure

Maurits Lugard and Anna-Shari Melin examine the new era of supply chain scrutiny and explain how the EMA’s new critical medicines lists will work.

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Making Manufacturing Sites Inspection-ready After the Pandemic Gap

Due to COVID-19, many pharmaceutical manufacturing sites have not experienced a regulatory inspection in several years. Raj Pai discusses how to ensure that Good Manufacturing Practices are in place.

Key Questions To Ask When Conducting Due Diligence of an Emerging Cellular or Gene Therapy Company

Following our recent post highlighting potential compliance risks at emerging cellular and gene therapy companies, Stephen Abreu and Chris Fanelli provide some questions and topics to explore when considering an investment or acquisition in this space. (more…)

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Buyer Beware: Compliance Risks at Emerging Cellular and Gene Therapy Companies

Chris Fanelli explains how emerging cellular and gene therapy companies present unique challenges and unique opportunities from a compliance perspective. He explores some of the tools that buyers can use to assess GxP compliance at the due diligence and post-acquisition stages.

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Might the Remote Monitoring of Clinical Trials in Europe Continue after Covid-19 Despite Data Privacy Concerns?

Olivier Goarnisson in Geneva and Francesca Blythe in London look at the benefits that were seen when some European countries temporarily permitted remote monitoring during the pandemic, and consider whether remote monitoring might have a long-term future if data privacy concerns are addressed.

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Why International Pharma Companies Need to Watch What Is Happening in the Netherlands

Maarten Meulenbelt explains why even companies headquartered in China or California need to be aware that the trend for ‘replacement pharmacy compounding’ may spread.

Over the last few years, the Netherlands has begun to develop its own pharmacy-compounded products as an alternative to authorised products, and as a benchmark for pricing and reimbursement of the authorised products that they seek to replace. (more…)

How to Guard Against Biologics and Medtech Patents Litigation

Life sciences companies are increasingly looking to the courtroom to resolve their disputes which were simmering during the pandemic. Ching-Lee Fukuda explains why litigation in the fields of biologics and medtech is now particularly likely, and how companies can best prepare for claims in these areas.

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