The #December edition of our monthly #LinkedIn #newsletter is available now, featuring the #latestnews and #developments from #TOPRA. This issue includes details of our #Christmas closing times, our #review of 2024 #video, the latest edition of #RegulatoryRapporteur, the 2024 #winners of the #TOPRAAwards for #RegulatoryExcellence, our call for #TOPRASymposium abstracts, #training opportunities and more ⬇️. #regulatoryaffairs #humanmedicines #pharmaceuticals #medicaldevices #veterinarymedicines
TOPRA - The Organisation for Professionals in Regulatory Affairs
Pharmaceutical Manufacturing
Enabling and promoting excellence in the healthcare regulatory profession
About us
TOPRA, The Organisation for Professionals in Regulatory Affairs, is a non-profit, non-political organisation which seeks to advance the status of the regulatory profession through education and provision of information to its members. Our current membership is drawn from over 50 countries, and members worldwide are actively involved in delivering the services needed by busy regulatory specialists. Members are drawn from industry, regulatory agencies and the consultancy community, and work in all sectors including medical technologies, biotech, borderline products and pharmaceuticals.
- Website
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http://www.topra.org
External link for TOPRA - The Organisation for Professionals in Regulatory Affairs
- Industry
- Pharmaceutical Manufacturing
- Company size
- 11-50 employees
- Headquarters
- London
- Type
- Nonprofit
- Founded
- 2004
- Specialties
- Training, Events, Information Services and Networking, regulatory affairs, pharmaceutical industry, veterinary industry, medical devices industry, medical devices, and healthcare
Locations
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Primary
Get directions
6th Floor
3 Harbour Exchange
London, E14 9GE, GB
Employees at TOPRA - The Organisation for Professionals in Regulatory Affairs
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Aman Khera EMBA FRAPS FTOPRA
Rebel Regulator in Healthcare | Drug & Device Development Executive | Board Member | Care for Rare | Healthcare Innovation, AI, Blockchain, Digital…
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Hans van Bruggen
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Stina Johansen
Quality & Regulatory Advisor | Combination Products | In-vitro Diagnostic Device | Medical Device | IVDR, MDR, CFR | EU & US Life Science | Founder…
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Virginia Acha
Focused on innovation policy that matters for people and the planet * Science & Regulatory policy global executive and advocate @ Merck Sharp & Dohme…
Updates
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The debate about #lecanemab, the first drug aimed at slowing the progression of #Alzheimerdisease, continues with the publication of The Lancet editorial. This encourages #regulators and #clinicians to ‘keep an open mind’ about its use. This #industrynews update from #RegulatoryRapporteur reports on the cost and safety concerns of #lecanemad compared to alternatives. Read it now 👉 https://lnkd.in/ezxrnRd6 #RegulatoryRapporteur is TOPRA’s peer-reviewed journal, publishing articles for members and sharing regular #industrynews updates for the wider #regulatoryaffairs community.
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According to a report from GSK, a recent #clinicaltrial called #DREAMM-7 reveals that #Blenrep can reduce the risk of death by 42% in multiple #myeloma after first relapse. However, the trial #results also revealed some concerns and #sideeffects. This #industrynews update from #RegulatoryRapporteur reports on the trial and provides updates on the safety and effectiveness of the drug. Read it now 👉 https://lnkd.in/e65u36YE #RegulatoryRapporteur is TOPRA’s peer-reviewed journal, publishing articles for members and sharing regular #industrynews updates for the wider #regulatoryaffairs community.
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We wish all our members and the wider #regulatoryaffairs community an enjoyable and restful #festive break. 🎄 We also pass on a #hugethanks to our wonderful #volunteers and staff for all your support over the last 12 months. We could not do it without you! 🙌 We are already looking forward to supporting the #regulatoryaffairs profession in 2025! In the meantime, we hope you all have a very merry #Christmas and a happy #NewYear! Please note that the #TOPRAoffices will be closed over the festive period between 1pm (GMT) on Tuesday 24 December 2024 and 9am (GMT) on Thursday 2 January 2025. Please email info@topra.org for any urgent queries during this period.
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As #2024 draws to a close, we’ve been reflecting on a busy but #productive year – watch our short #video to enjoy some of our many #highlights. 🎞 These include our #RegulatoryCareersLive events, our #TOPRASummit, the launch of our #Engage+ app, our #Symposium in Rotterdam, and the ceremony for the #TOPRAAwards for #RegulatoryExcellence in London! Thank you to everyone who contributed to their #success! 👏 We wish all our members and the wider #regulatoryaffairs community an enjoyable and restful festive break. 🎄 We also pass on a #hugethanks to our wonderful #volunteers and staff for all their support over the last 12 months. We could not do it without you! 🙌 We are now looking forward to supporting the #regulatoryaffairs profession in 2025! Please note that the #TOPRAoffices will be closed over the festive period between 1pm (GMT) on Tuesday 24 December 2024 and 9am (GMT) on Thursday 2 January 2025. Please email info@topra.org for any queries during this period.
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We are committed to supporting the #professionaldevelopment of #regulatoryaffairs professionals across the globe. That’s why we are delighted to be able to offer Bursaries to support the #traininganddevelopment needs of #regulatoryaffairs professionals in low-to-middle income countries. We currently offer two types of Bursary: 🔹 Education Bursaries for individuals at the start of their #regulatoryaffairs career 🔹 Training Bursaries for staff based in national or regional authorities The fund is limited so we recommend submitting your application in good time, noting that you can only apply once in the same year. Find out more and how to apply 👉 https://bit.ly/3BlB7a4
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The European Medicines Agency (#EMA) has launched the European Medicines Shortages Platform (#ESMP) to help track the supply and demand of #medicine in the #EuropeanUnion (#EU). This platform will reduce the likelihood of future shortages and its use will become mandatory from February 2025. This #industrynews update from #RegulatoryRapporteur reports on this new #regulatoryguidance for #medicine #wholesalers and #manufacturers operating within #GreatBritain. Read it now 👉 https://lnkd.in/eMc8rzP6 #RegulatoryRapporteur is TOPRA’s peer-reviewed journal, publishing articles for members and sharing regular #industrynews updates for the wider #regulatoryaffairs community.
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