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Pharmaceutical C-suite update
With two knighthoods in the last month, here EPR discusses five developments in the drug development community’s C-suite.
List view / Grid view
The European Medicines Agency (EMA)
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EMA’s PRAC June meeting highlights
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) finds the benefits of amfepramone medicines do not outweigh their risks and addressed possible links between COVID-19 vaccines and menstruation.
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EMA’s first critical medicines list for COVID-19
The approved COVID-19 vaccines and treatments on the list will be monitored to prevent and mitigate the impact of shortages.
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What lies ahead for IDMP?
The EU’s identification of medicinal products (IDMP) standards implementation was all set to go ahead, when the EMA suddenly announced a change of plan. The DADI user interface will now enable structured data submissions for the EMA PMS, at least for the near future. Drawing on recent dialogue with the…
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Early phase CGT trials: key design elements correlating to distinctive biological characteristics
With increasing numbers of cell and gene therapies (CGTs) entering clinical trials, Dr Dave Li and Dr Anna Baran of KCR Consulting discuss how the biological characteristics of CGTs should be taken into account with early phase trial designs.
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Preparation is key: the role of scientific due diligence in successful partnerships
Small biopharma companies often need to partner with larger firms to achieve their goals, but such agreements can fail if preparations are poor. Here, Diane Seimetz and Jörg Schneider at Biopharma Excellence discuss how due diligence smooths the path to collaboration.
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Manufacturing Classification System (MCS)
Here, David Elder elucidates the workings of the manufacturing classification system (MCS) used to guide decision making for drug formulators.
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Setting a new standard of care for liver MRI contrast agents in patients with reduced kidney function
A ‘hot’ topic on the radar of radiologists in recent years has been the safety of the potentially toxic gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI). This is especially pertinent in the detection of focal liver lesions for patients with poor kidney function due to potentially fatal…
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, March 2022
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
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PRIME scheme benefits drug development, finds EMA report
The report outlines the positive impact the EMA’s PRIority Medicines (PRIME) scheme has had on drug development for unmet medical need over the last five years.
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EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
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Effective data management: lessons to learn from Big Pharma
Here, Frits Stulp and Duncan van Rijsbergen of Iperion explore how startups can establish the most efficient data management processes and systems, avoiding the kind of mistakes made by Big Pharma.
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EU adopts electronic product information standard for medicines
The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.
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DARWIN EU® Coordination Centre to integrate real-world evidence into medicines regulation
EMA will establish the DARWIN EU® Coordination Centre to develop and manage a network of real-world healthcare data sources across the EU.
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Understanding the new EU Clinical Trial Regulation: seven things sponsors should know
In this article, Sarah Bly and Aman Khera of Worldwide Clinical Trials break down the seven key differences between the EU Clinical Trial Directive and new EU Clinical Trial Regulation, discussing when and how sponsors should begin submitting their trials through the new CTIS portal system.
