Ensuring continued safety of our products is vital to our mission: Better outcomes for more patients. Julia Pfaff, our Head of Pharmacovigilance, sheds light on the critical process of post-approval product monitoring. Explore our clinical breakthroughs: https://lnkd.in/eT_aduCR
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In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:
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In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:
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In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:
The EU-CTR transition: Four key ways to prepare now
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In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:
The EU-CTR transition: Four key ways to prepare now
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In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:
The EU-CTR transition: Four key ways to prepare now
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In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:
The EU-CTR transition: Four key ways to prepare now
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Vice President (Global leader) Integrated Solutions Strategy, DEI Leader, Co-Lead of Global Disability Steering Committee, Professor (Hon), Entrepreneur in Residence, GlobalScot, Speaker and Board member.
In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:
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In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:
The EU-CTR transition: Four key ways to prepare now
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✨ Now that the conference app is live for DIA #GPVRMS24 - you can sign up for the roundtable discussions of your choice! ✨ Join colleagues to discuss the topics that matter most to you! Attendees will have the opportunity to sign up for a roundtable of your choice via the conference app. Roundtables are first come first serve. Roundtable topics to include: ⏺ The potential for greater alignment of REMS and aRMM in complex risk minimisation scenarios hosted by Mark Perrott ⏺ Implementation of the FDA Medical Queries (2 Tables) – hosted by Barbara Hendrickson/ Y. Veronica Pei, MD, MEd, MPH, FACEP, and Scott Proestel ⏺ What are the challenges of implementing intelligent automation in Pharmacovigilance? hosted by Nicole Baker PhD ⏺ Managing complexities in ICSR reporting hosted by Brian. Edwards ⏺ Recent Pharmacovigilance Audit/Inspection Findings hosted by Janine Gavin-Poulter ⏺ Medical Devices: Challenges in keeping pace with Evolving Regulatory Landscape for Clinical and Post-Marketing Device Vigilance hosted by Vineet Kacker ⏺ Emerging Technologies in Pharmacovigilance: A Glocal Approach hosted by @Viola Dzouza Not yet registered? Sign up -> diaglobal.org/GPVRMS24
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G&L Blogs: Rachael O'Kane continues her exploration of the topics and trends featured at the 2023 TOPRA Symposium and looks the the value of patient opinion and feedback. Read more: https://lnkd.in/gun7zb99 #HealthcareAdvisors #RegulatoryAffairs #QualityAssurance #ClinicalDevelopment TOPRA - The Organisation for Professionals in Regulatory Affairs
TOPRA Symposium 2023: Patient engagement in medicines’ regulatory…
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CEO and Co-Founder at hyrd
2moJulia Pfaff nice interview :)