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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.
External link for TOPRA - The Organisation for Professionals in Regulatory Affairs
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The European Commission (#EC) has drafted the #GreenClaimsDirective to limit #greenwashing by ensuring green claims are verifiable and comparable. This article from Sebastien Oguey, Clémentine Oguey and Vera Houriet in the #July / August 2024 issue of #RegulatoryRapporteur provides an overview of the Green Claims Directive. Focusing on animal feed products, it looks at how industry anticipates its enforcement and the challenges it represents. Read their article now 👉 https://lnkd.in/esCnJixR #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This edition focuses on #sustainability and looks at how regulators and other organisations are implementing sustainable strategies and frameworks to mitigate the potential risk of medicinal products on the environment. Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur 👉 www.topra.org/join
The #biologicalsafety assessment of #medicaldevices is crucial to ensure they are safe for human use. While #invivo testing has been the main method for these assessments, there is a growing shift towards the development of non-animal-based new approach methodologies (#NAMs). This article from Jocivânia OLIVEIRA DA SILVA and Marielle Fournier in the #July / #August 2024 issue of #RegulatoryRapporteur discusses the challenges and opportunities of #NAMs in reducing animal testing and their recent development in biological safety assessments. Read their article now 👉 https://lnkd.in/eN4xUMpa #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This edition focuses on #sustainability and looks at how regulators and other organisations are implementing sustainniable strategies and frameworks to mitigate the potential risk of medicinal products on the environment. Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur 👉 www.topra.org/join
In our #July / August 2024 issue of #RegulatoryRapporteur, Cormac O'Prey (Kestrel Technology Consulting) and Davina Stevenson explain why taking sustainability seriously is essential for medical and healthcare businesses, offering tangible benefits and long-term success. Read the article now 👉 https://lnkd.in/eK_z43Pw #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This edition focuses on #sustainability and looks at how regulators and other organisations are implementing sustainable strategies and frameworks to mitigate the potential risk of medicinal products on the environment. Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur 👉 www.topra.org/join
The #TOPRA #Symposium is #Europe’s premier #conference for #healthcare #regulatoryaffairs, and this year's theme is 'Improving #healthoutcomes through #regulatoryexcellence'. Andrea Laslop of the Austrian Agency for Health and Food Safety (AGES) and Sandra Lourenço of Arriello will lead the first Parallel Session of the Symposium, PS1: Resolving Specific Development Hurdles via #Scientific Advice We are also delighted to announce that this address, which takes place on 2 October, will feature Mireille M. Muller of Novartis, Marianne Lunzer of AGES and Jane Moseley of the European Medicines Agency (EMA). Join them in-person in #Rotterdam, the Netherlands on 30 September – 2 October for the latest industry insights and developments in #humanmedicines, #veterinarymedicines and #medicaldevices/ #IVDs. This year, we are hosting the Symposium in partnership with the Medicines Evaluation Board (MEB)/ College ter Beoordeling van Geneesmiddelen (CBG), the #Netherlands' national authority of #medicines and #health products. #TOPRAmembers can benefit from discounted rates on the registration fees. Find out more about the Symposium programme and book now 👉 www.topra.org/symposium
🚨1 week left to book!🚨 Learn how to prepare and manage #pharmaceutical (#CMC) information the #regulatorydossier’s Module 3. Our Getting the CMC Dossier Right #CRED course will teach you the common pitfalls to avoid as well as being given the opportunity to interact with speakers from regulatory agencies in a neutral environment. By attending this in-person #trainingcourse on 4-5 September 2024 in #London, UK, you will: 🔹 Gain a comprehensive overview of the requirements for Module 3 of the regulatory dossier 🔹 Participate in case studies and interactive lessons 🔹 Build a network that will support you for the rest of your career 🔹 Earn 14.5 #CPD hours Led by #expertspeakers, this course is suitable for less experienced #regulatoryaffairs professionals who require comprehensive information on CMC, as well as experienced professionals who are new to CMC. Book now 👉 https://lnkd.in/eVk5gJ87 This course is part of our programme of CRED courses which are for experienced professionals committed to developing their regulatory and management competencies. Discounted rates are available for those working for regulatory or government agencies, academic institutions, charities, patient groups, or in full-time education.
In the #July / #August 2024 issue of #RegulatoryRapporteur, Bengt Mattson and Davina Stevenson discuss sustainability and the potential impact of #EU #environmental legislation on the #pharmaceutical sector. Read the article now 👉 https://lnkd.in/eGmHPUMU #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This edition focuses on #sustainability and looks at how regulators and other organisations are implementing sustainable strategies and frameworks to mitigate the potential risk of medicinal products on the environment. Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur 👉 www.topra.org/join
Join us between 30 September and 2 October in #Rotterdam to learn about the latest developments and #innovations in #regulatoryaffairs and to benefit from the networking with our international community. This year’s Symposium, which has the theme of 'Improving #healthoutcomes through #regulatoryexcellence', will be hosted in partnership with the Medicines Evaluation Board (#MEB)/ College ter Beoordeling van Geneesmiddelen (#CBG), the #Netherlands' national authority of medicines and #health products. The Chairs for each programme stream are: 🔹 #Humanmedicines and overall Symposium Chair – Carlos Langezaal, Senior Director Regulatory Affairs, Premier Research, UnitedStates 🔹 #Veterinarymedicines – Rick Clayton, Technical Director, HealthforAnimals and AnimalhealthEurope, Belgium 🔹 #MedicalDevices/ #IVDs – Margareth Jorvid CEO, Regulatory Affairs & Quality Assurance at Methra Uppsala AB, Sweden Book now 👉 www.topra.org/symposium #TOPRAmembers also enjoy an additional saving when booking, as do those working for regulatory or #government #agencies or #academic institutions (who can save 25%), and those working for #charities, #patient groups or in full-time #education (who can save 50%).
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
The provision of electronic patient information leaflets (#ePILs) can help address many existing issues surrounding the #accessibility of #medicinalproduct information in #paperleaflet format. Several countries have successfully implemented #ePILs, and the #UK is currently initiating discussions to do so. This article is authored by Marie Woe, Erika Solange A. and Kathryn Sharpe on behalf of the UK ePI Task Force, supported by The Association of the British Pharmaceutical Industry (ABPI), the British Generic Manufacturers Association (BGMA) and PAGB, the consumer healthcare association. Published in the #July / #August 2024 issue of #RegulatoryRapporteur, it discusses the challenges and opportunities involved in moving from paper #PILs to #ePILs in the UK. Read their article now 👉 https://lnkd.in/ewyN7ksH #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This edition focuses on #sustainability and looks at how regulators and other organisations are implementing sustainable strategies and frameworks to mitigate the potential risk of medicinal products on the environment. Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur 👉 www.topra.org/join