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pharmacovigilance
This page shows the latest pharmacovigilance news and features for those working in and with pharma, biotech and healthcare.
J&J's single-dose COVID-19 vaccine secures approval from the UK’s MHRA
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) also confirmed that the overall benefit-risk profile of J&J’s COVID-19 vaccine is positive.
Latest news
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J&J resumes US rollout of single-dose COVID-19 vaccine
On 20 April, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) also confirmed that the overall benefit-risk profile of Johnson &Johnson’s (J&J) COVID-19 vaccine
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EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the overall benefit-risk profile of Johnson &Johnson’s (J&J) COVID-19 vaccine is positive.
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CureVac outlines COVID-19 vaccine production plans ahead of regulatory approval
Meanwhile, Bayer is contributing its expertise and established infrastructure in clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance to support the development, supply and key territory
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J&J delays EU COVID-19 vaccine rollout following pause in the US
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has also started a review into reports of people developing blood clots after receiving the J&J COVID-19 vaccine.
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UPDATE: US pauses rollout of J&J’s COVID-19 vaccine amid reports of rare blood clots
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has also started a review into reports of people developing blood clots after receiving the J&J COVID-19 vaccine.
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Approximately 18 fully matching, plus 150 partially matching documents found.
Latest Intelligence
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Listen, learn and lift off
Legal, compliance and pharmacovigilance are usually the last people to be consulted so I don’t blame them for being cautious,” he said.
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Medicinal data – what’s next for IDMP?
This is significant. Up to now, EMA’s chief goals for IDMP have been to streamline the regulatory assessment and authorisation of medicinal products and to support pharmacovigilance activities.
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Transforming clinical trial data into a long-term asset
When it comes to the archive, patchy access to TMF data could hinder pharmacovigilance procedures and place obstacles in the path of scientific discovery and commercial growth. ... Throughout the product life cycle, good practice in archiving can prove
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What Hemingway got right about patient communications
But when physicians asked if they could use these apps to manage their patients remotely, we sensed a potentially insurmountable GDPR and pharmacovigilance challenge.
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Mastering data protection in the pharma industry
data within pharmacovigilance reporting requirements while complying with the EU data protection rules. ... The ABPI Pharmacovigilance Expert Network, the Pharmaceutical Information and Pharmacovigilance Association and pvlegal,.
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Approximately 3 fully matching, plus 29 partially matching documents found.
Latest appointments
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Novo Nordisk target Ablynx reshuffles its board
Dr Hensen’s expertise lies in orphan drug research and development, international marketing and commercialisation and has experience in regulatory, pharmacovigilance, medical marketing and business development knowledge.
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Immodulon Therapeutics bolsters senior team
Also joining from Celgene is Dr Graham Burton (pictured right), who previously served the pharma group as its senior vice president of regulatory, pharmacovigilance and clinical quality and has over 30
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Topas Therapeutics appoints chief development officer and chief medical officer
Forging a 20-year-career spanning clinical development, regulatory and medical affairs and pharmacovigilance business, Dr Sandbrink’s expertise saw him most recently at Forward Pharma, where he served as executive
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Ferring appoints executive VP and chief medical officer
take the helm of its global medical affairs, quality assurance and pharmacovigilance business.
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NDA Group appoints new vice president
Eynde joins the group from Chemo – Exeltis where he was head of R&D, regulatory affairs and pharmacovigilance.
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Approximately 2 fully matching, plus 24 partially matching documents found.
Latest from PMHub
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Carrot Pharma Recruitment
Marketing, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Clinical Research.
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Ashfield U.S. hires two senior executives for new Medical Affairs business unit
Ashfield’s Pharmacovigilance business. ... The new Medical Affairs business unit will combine Ashfield’s existing Medical Information, Pharmacovigilance and Medical Science Liaison services.
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How to be a patient
We can listen into social media conversations, but many companies are wary about actively participating due to pharmacovigilance issues.
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Patient support blog series: Step 2 to a successful patient support programme
Pharmacovigilance needs to monitor the performance of products in a wider population and look for uncommon side effects.
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TRIO OF HIRES SIGNAL PEGASUS' NORTHERN GRIT
pharmacovigilance services.
More from PMHub
Approximately 1 fully matching, plus 26 partially matching documents found.
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