TOPRA - The Organisation for Professionals in Regulatory Affairs

Our #IVD #RegulatoryAffairs for Global Markets course is ideal for professionals who need a guide on #bestpractice for #submissions in #globalmarkets outside of the #EU. This two-day #CRED course will cover the latest #updates in #globalmarkets including the #US, #Canada, #China and #Brazil and will also address key areas such as #Software as a #MedicalDevice and Unique Device Identification. Delivered by #industryexperts including Stuart Angell (mTOPRA) of IVDeology Ltd, Ashleigh Batchen of TÜV SÜD, Nadine Cabellero of Thermo Fisher Scientific, Eamon Docherty of Biocartis NV, Hamish King of Cisema, Eliana Silva de Moraes of SILVA DE MORAES & ASSOCIES and Andreas Stange of TÜV SÜD. In the short video below ⬇️, Ashleigh Batchen, who will be co-chairing the course with Stuart Angell (mTOPRA), explains why you should join us #online on 19-20 November. Book now 👉 https://lnkd.in/eNv6kDYS This course is part of our programme of #CRED courses which are for #experiencedprofessionals committed to developing their #regulatory and #management #competencies and provides 14.5 hours of #CPD upon successful completion. #TOPRA #members are eligible for discounted rates, as are professionals based in low-income countries (as defined by the World Bank), those working for #regulatory or #government #agencies, #academic institutions, #charities, #patient groups, or in full-time #education.

Achieving #CharteredScientist status will demonstrate your skills and experience as a #regulatoryaffairs professional. Our next deadline for applications is #5December2024. In addition to formally recognising your competence, it will enable you to join a #globalcommunity of scientists and take the next step in your #careerdevelopment. Find out more about how you can #StandOutInScience as a #CharteredScientist with #TOPRA 👉 bit.ly/3VMFQcE We are licensed by the Science Council to offer #professionalregistration status for #RegisteredScientist (RSci) and #CharteredScientist (CSci) to eligible #regulatoryaffairs professionals. #TOPRA #RecognisingScientificExcellence #professionaldevelopment #careers #StandOutInScience

The finalists for the #TOPRA #Awards for #RegulatoryExcellence 2024 have been announced! The #Innovation #Award, #sponsored by fme US, LLC honours outstanding achievements in the deployment and successful implementation of #innovative ideas. The finalists in the #Innovation category, are: ⭐CAPTIS team, Celegence, UK, USA, the Netherlands, Romania and India ⭐Dossplorer team, Celegence, USA and the Netherlands ⭐Global Regulatory Intelligence (GRI) Freyr Solutions, India ⭐Roche, UK, Switzerland and USA The #Innovation #Award is one of #nine categories that reflect the breadth of achievement taking place across the #regulatoryaffairs #profession. The winners will be revealed at our gala dinner and ceremony on 28 November 2024 at Chartered Accountants’ Hall in #London. Join us for a very special evening of celebrating the #verybest in regulatory affairs. Find out more 👉 https://lnkd.in/exzrG8PA Since 2010, these #annual #international #awards have #celebrated #achievement and #bestpractice in #regulatoryaffairs. A huge thanks to all our category sponsors for supporting #excellence in #regulatoryaffairs: Celegence, Cencora, Element Materials Technology , fme US, LLC, G&L Healthcare Advisors, MAIN5, PharmiWeb.jobs: Global Life Science Jobs and Roche. #RegAwards24 #CelebrateAColleague #PayItForward

The finalists for the #TOPRA #Awards for #RegulatoryExcellence 2024 have been announced! The #Horizon #Award, #sponsored by Roche, recognises outstanding ability in individuals with fewer than five years’ experience in the #regulatoryaffairs profession. The finalists in the #Horizon category are: ⭐ Anuya Aras, Germany ⭐ Leticia Monjas Gómez, UK ⭐ Monica Pianella, UK ⭐ Faizah Rasul, UK ⭐ Francesca Ward, UK ⭐ Samantha Watkins, UK The #Horizon #Award is one of #nine categories reflect the breadth of achievement taking place across the #regulatoryaffairs #profession. The winners will be revealed at our gala dinner and ceremony on 28 November 2024 at Chartered Accountants’ Hall in #London. Join us for a very special evening of celebrating the #verybest in regulatory affairs. Find out more 👉 https://lnkd.in/exzrG8PA Since 2010, these #annual #international #awards have #celebrated #achievement and #bestpractice in #regulatoryaffairs. A huge thanks to all our category sponsors for supporting #excellence in #regulatoryaffairs: Celegence, Cencora, Element Materials Technology, fme US, LLC, G&L Healthcare Advisors, MAIN5, PharmiWeb.jobs: Global Life Science Jobs and Roche. #RegAwards24 #CelebrateAColleague #PayItForward

The finalists for the #TOPRA #Awards for #RegulatoryExcellence 2024 have been announced! The #Futures #Award, #sponsored by G&L Healthcare Advisors, acknowledges the role of #regulatoryaffairs scientists in realising the potential of cutting-edge #technologies. The finalists in the #Futures category are: ⭐ Anna Koptina Gültekin, Sweden ⭐ ORCHARD THERAPEUTICS LIMITED's OTL-200 Regulatory Team, UK The #Futures #Award is one of #nine categories reflect the breadth of achievement taking place across the #regulatoryaffairs #profession. The winners will be revealed at our gala dinner and ceremony on 28 November 2024 at Chartered Accountants’ Hall in #London. Join us for a very special evening of celebrating the #verybest in regulatory affairs. Find out more 👉 https://lnkd.in/exzrG8PA Since 2010, these #annual #international #awards have #celebrated #achievement and #bestpractice in #regulatoryaffairs. A huge thanks to all our category sponsors for supporting #excellence in #regulatoryaffairs: Celegence, Cencora, Element Materials Technology, fme US, LLC, G&L Healthcare Advisors, MAIN5, PharmiWeb.jobs: Global Life Science Jobs and Roche. #RegAwards24 #CelebrateAColleague #PayItForward

Our upcoming Optimising #Regulatory Strategies for #Orphan #Drugs course will guide you through the regulatory processes required to speed up approval and access for #raredisease #treatments. The #expertspeakers sharing their knowledge and insights on this #training course will include: ◾Joanna Allen of Biogen ◾Ana Maria Bühlmann of Roche Products Ltd ◾João Duarte of Ipsen  ◾Adriaan Fruijtier of CATS Consultants GmbH ◾Tara Hutton of Biogen ◾Jennifer Svec of The Reg Group Pty Ltd By attending this #online #trainingcourse on 26 November 2024, you will:    ✅ Acquire key information about #regulatoryprocesses intended to expedite early access to #innovative #medicines ✅ Get practical advice on how to prepare and manage #orphansubmissions ✅ Engage in hands on #casestudies and interactive sessions ✅ Build a #network that will support you for the rest of your #career ✅ Earn 8 #CPD hours Register now 👉 https://lnkd.in/eiTMMfrK This session is part of our programme of #CRED #courses for #experiencedprofessionals committed to developing their regulatory and management competencies.    Discounted rates are available for those working for #regulatory or #governmentagencies, #academicinstitutions, #charities, #patientgroups, or in full-time #education.

The finalists for the #TOPRA #Awards for #RegulatoryExcellence 2024 have been announced! The #Education #Award, #sponsored by Element Materials Technology, recognises individuals who have made a significant contribution to the #education and #training of #regulatoryaffairs. The finalists in the #Education category, are: ⭐ Monir El Azzouzi, Switzerland ⭐ Thuy Mason, UK ⭐ RAJASHRI OJHA, India ⭐ Roche / Genentech Early Regulatory Talent Program, UK and Canada The #Education #Award is one of #nine categories that reflect the breadth of achievement taking place across the #regulatoryaffairs #profession. The winners will be revealed at our gala dinner and ceremony on 28 November 2024 at Chartered Accountants’ Hall in #London. Join us for a very special evening of celebrating the #verybest in regulatory affairs. Find out more 👉 https://lnkd.in/exzrG8PA Since 2010, these #annual #international #awards have #celebrated #achievement and #bestpractice in #regulatoryaffairs. A huge thanks to all our category sponsors for supporting #excellence in #regulatoryaffairs: Celegence, Cencora, Element Materials Technology, fme US, LLC, G&L Healthcare Advisors, MAIN5, PharmiWeb.jobs: Global Life Science Jobs and Roche. #RegAwards24 #CelebrateAColleague #PayItForward

The finalists for the #TOPRA #Awards for #RegulatoryExcellence 2024 have been announced! The #Contribution #Award, #sponsored by MAIN5, honours #regulatoryaffairs #professionals who have made a significant contribution to a team or regulatory project(s) over the past three years. The finalists in the #Contribution category, are: ⭐ Tala AlGhabra, UK ⭐ Michelle Blake, UK ⭐ Eamonn McGowran, Ireland ⭐ Samhitha Mohan, USA ⭐ PPD's RIM Implementation Team, UK, USA and Bulgaria ⭐ David Uguen, UK and France The #Contribution #Award is one of #nine categories that reflect the breadth of achievement taking place across the #regulatoryaffairs #profession. The winners will be revealed at our gala dinner and ceremony on 28 November 2024 at Chartered Accountants’ Hall in #London. Join us for a very special evening of celebrating the #verybest in regulatory affairs. Find out more 👉 https://lnkd.in/exzrG8PA Since 2010, these #annual #international #awards have #celebrated #achievement and #bestpractice in #regulatoryaffairs. A huge thanks to all our category sponsors for supporting #excellence in #regulatoryaffairs: Celegence, Element Materials Technology, fme US, LLC, G&L Healthcare Advisors, MAIN5, PharmaLex, PharmiWeb.jobs: Global Life Science Jobs and Roche. #RegAwards24 #CelebrateAColleague #PayItForward

We are pleased to announce that #TOPRA has been confirmed as an #AssociationPartner for the fourth #AfriSummit which will take place on between 3 and 6 November in #Cairo, #Egypt. AfriSummit 2024 is a prominent conference and summit dedicated to addressing the challenges and opportunities facing #pharma and #medicaldevice regulations in #Africa. #Earlybird tickets are available until 31 August 2024. Over two hybrid streams, #PharmaReg (3-4 November) and #MedDevReg (5-6 November), AfriSummit will provide a forum for sharing best practice, showcasing innovative solutions, and highlighting success stories from the pharmaceuticals and medical devices sectors. Meanwhile, the event’s onsite streams, PV AfriSummit (5-6 November) and #eCTD AfriSummit, will provide specialised training in pharmacovigilance and electronic Common Technical Documents (eCTD). As an Association Partner, TOPRA has also arranged for members to get 20% discount on AfriSummit 2024 registration fees – please email us at membership@topra.org for more information.  Find out more 👉https://lnkd.in/e4HZbD-u