TOPRA - The Organisation for Professionals in Regulatory Affairs

Our #Regulatory #Strategy for Established Active Substances #masterclass will take place on 1-3 April 2025 in #London, UK and #online. The #expertspeakers sharing their knowledge and insights on this course will include ?Adrian Andrews of Teva ?Cait Brennan of Chanelle Pharmaceuticals ?Bob Clay of Highbury Regulatory Science Limited ?Teresa Doyle of Shorla Oncology ?Sarah Faircliffe of Bird & Bird ?Anders Fuglsang of Fuglsang Pharma ?Sara Wexler Koblitz of Hyman, Phelps & McNamara, P.C. ?Eva Kopecna of Acino International ?Valérie Policar of PPD, Thermo Fisher Scientific ?Orlaith Ryan of Shorla Oncology ?Ruchika Sharma of Shorla Oncology ?Dr Jon Sisson of tranScrip Register now to join us in April (19 hours #CPD available) ?? https://lnkd.in/e3nYMYxj

Our Overview of #EU #Pharmaceutical #RegulatoryAffairs course (previously known as the Spring Introductory Course) is ideal for those who are new to regulatory affairs and want to get a comprehensive understanding of the #pharmaceutical #industry, as well as established #professionals who want to update their knowledge. ?? In the short video below, previous delegate Justin Hayzen, Regulatory Affairs Manager - CMC at Porton Biopharma Ltd, explains how this course helped him switch to regulatory affairs, after spending his career in a number of technical roles within the pharmaceutical industry. ?? This three-day in-person #course between 15-17 April 2025 in #London, UK will explore all aspects of the #productdevelopment process, as well as providing a sound overview of #EU legislation and regulatory procedures. There will also be an exploration of the central role #regulatoryaffairs plays in #healthcare companies and the development cycle of new #drugs. Book now ?? https://lnkd.in/eYU_CuTi #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.

#Regulatoryaffairs professionals spend a lot of time on #variations, so it’s vital to be able to get them right quickly and efficiently. This practical course will explain the main principles of the #EU variations regulation and cover the intricacies of grouping and work-sharing procedures, using examples to illustrate the categorisation guidelines. By attending this training on 27-28 May 2025 either in-person (#London, UK) or #online, you will: ? Learn how to strategise the submission of variations to #savemoney and avoid invalidation ? Gain an up-to-date overview of variation classification and procedures in the EU ? 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 #regulatoryaffairs professionals who are developing their experience, as well as those who are going into the area of processing and submitting variations. This course is also a good refresher for those looking to update their knowledge in this subject area. Book now ?? https://lnkd.in/evxV8bD4 This course is part of our programme of #CREDcourses for experienced professionals committed to developing their regulatory and management competencies. #TOPRA #members are eligible for #discounted rates, as are those working for regulatory or government agencies, academic institutions, charities, patient groups, or in full-time education.

It’s the end of #CharteredWeek! Be the one that stands out with Chartered Scientist or Registered Scientist status. Achieving a professional registration status sets you apart as a trusted, skilled, and committed regulatory affairs professional. It provides formal recognition of your expertise while enhancing your credibility, career prospects, and professional impact. ?? Our next deadline for applications is 2 April 2025. Discover how CSci and RSci can help you stand out and take your career to the next level with #TOPRA ?? https://lnkd.in/eqyfiC88 We are licensed by the Science Council to offer #professionalregistration status for #RegisteredScientist (RSci) and #CharteredScientist (CSci) to eligible #regulatoryaffairs professionals. #RecognisingScientificExcellence #professionaldevelopment #careers #StandOutInScience

Successful and rewarding #careers in #healthcare #regulatoryaffairs start at #RegulatoryCareersLive. Like many delegates, Erica Park found our RCL event to be a great introduction to the regulatory affairs #profession. Join us on 28 March for our next #RegulatoryCareersLive in #Dublin (Ireland) and a day full of essential #careeradvice. In addition to opportunities to network with representatives from a range of exhibiting organisations, our packed programme features expert speakers who will share their insights on topics ranging from the skills and competencies you need, through to applying for jobs and preparing for interviews. Book your free place now ?? www.topra.org/rcl Thanks to all our exhibitors and supporters who include Health Products Regulatory Authority (HPRA), Perrigo Company plc, PharmiWeb.jobs: Global Life Science Jobs and tranScrip. #RegulatoryCareersLive is aimed at professionals who have just started or are considering a career in #healthcare #regulatoryaffairs as well as #lifescience students and recent #graduates. #TOPRA #ChooseRegulatoryAffairs #RegulatoryAffairsSpecialist #careers

#TOPRA is entering an exciting chapter under the presidency of Aman Khera EMBA FRAPS FTOPRA in #2025. With a vision centred on growth, collaboration and a people-first #culture, Aman is dedicated to driving meaningful change for our members, community and the industry as a whole. Aman is an accomplished regulatory expert within industry. Her experience and expertise encompasses global strategic direction in drug and device development with the #regulatoryaffairs lens, and she has led a wide range of regulatory projects providing strategy and development services for a variety of companies. In this video, Aman explains what she would like to achieve as #TOPRA #President this year. Intentions for the duration of her tenure include: ??Strengthening connections with TOPRA members ??Ensuring members needs are met through effective #training, development and future skills growth ??Integrating #patient voices into #healthcare regulatory spaces ??Leveraging technological advancements ??Fostering international collaboration and #regulatory harmonisation practices to contribute to a healthier global community Find out more about our #Board of #Directors ?? https://lnkd.in/eDUQAFbW

As #CharteredWeek comes to a close, we hear from Jay Gandecha MTOPRA CSci as he reflects on what achieving #CharteredScientist (CSci) status means to him and why it was an important milestone in his career. Becoming a Chartered Scientist is a valuable way to demonstrate your expertise, commitment, and impact as a #regulatoryaffairs professional. It provides formal recognition of your skills and experience while supporting your long-term #careerdevelopment. ?? Our next deadline for applications is 2 April 2025. Discover the benefits of CSci and how it can elevate your professional profile with #TOPRA ?? https://lnkd.in/eqyfiC88 We are licensed by the Science Council to offer #professionalregistration status for #RegisteredScientist (RSci) and Chartered Scientist (#CSci) to eligible #regulatoryaffairs professionals. #RecognisingScientificExcellence #professionaldevelopment #careers #StandOutInScience

Without the generous support of our valued #community of #volunteers, we would not be able to operate in the way we do. Our volunteers help us steer, shape and deliver our wide range of activities for the benefit of our #members and the wider #regulatoryaffairs profession. ???? Benefits of being a #TOPRA volunteer include: ?Increasing your technical knowledge ?Extending your network of contacts ?Raising your profile within the profession ?Developing skills such as team-working or chairing Being a volunteer can also be considered as continuing professional development and will therefore contribute to your CPD hours. Find out more about our volunteering opportunities ?? https://lnkd.in/edJ7T_FN