TOPRA newsletter - August 2024

Welcome to our August newsletter, featuring the latest news and developments from TOPRA - The Organisation for Professionals in Regulatory Affairs. We are the international professional membership organisation for healthcare regulatory affairs, and support career progression and the promotion of excellence across the profession.

Regulatory Rapporteur – July/August edition available now

The July/August issue of Regulatory Rapporteur focuses on sustainability. It looks at how regulators and other organisations are implementing sustainable strategies and frameworks to mitigate the potential risk of medicinal products on the environment. Regulatory Rapporteur is TOPRA’s respected online journal, published 11 times per year and available free to TOPRA members. Non-members can now register for complimentary access to one journal article and an additional five views of industry news content every month.

Regulatory Careers Live 2024 - book your free place

Regulatory Careers Live (RCL) is Europe's only careers fair dedicated to healthcare regulatory affairs. Book your free place now for our next event on 12 June in Brussels to get insights from experts from industry, regulatory bodies and recruiters. For more insights into careers in regulatory affairs, stream our episode of RegRapPod - InConversation which features previous RCL speaker Helena Corte-Real (Vice President, Regulatory Portfolio Data and Content Lead at Roche) describing how she got started.

Volunteer Awards - nominate now

We value and appreciate all the support and input we receive from our volunteers, and one of the main ways in which we recognise their contribution is through our annual Volunteer Awards. These awards are a great opportunity to show your appreciation for their hard work and commitment. You can nominate individuals who have ‘gone the extra mile’ for the Distinguished Service Award, or outstanding teams for the Top Team Award. This year’s deadline for nominations for both awards is Friday 30 August 2024.

You still have time to book for next month's TOPRA Symposium

Held annually since 2004, the TOPRA Symposium is Europe’s premier conference for healthcare regulatory affairs. With dedicated programme streams for human medicines, medical devices/IVDs and veterinary medicines, it is an unmissable event in the regulatory affairs calendar. The 2024 Symposium will take place earlier this year in Rotterdam, between 30 September and 2 October, so join us to learn about the latest developments and innovations. The theme is 'Improving health outcomes through regulatory excellence', and we are hosting it in partnership with the Medicines Evaluation Board (MEB), the Netherlands' national authority of medicines and health products. Book now.

Demonstrate your status. Become a TOPRA Fellow

Fellowship is TOPRA’s highest grade of membership and a mark of excellence and distinguished contribution to regulatory affairs. There are many benefits to be enjoyed when you become a TOPRA Fellow including: recognition and status with FTOPRA post-nominals, credibility and influence, and access to exclusive networking events TOPRA members with over 10 years’ experience in regulatory affair can apply and there is no additional fee. Simply complete our application form to demonstrate how you meet the criteria, with two statements from supporting sponsors.

TOPRA is Association Partner for AfriSummit 2024

Taking place in Cairo (Egypt) between 3 and 6 November, AfriSummit?2024 will bring together professionals from across the?pharma and medical device sectors, alongside agencies and authorities?from across Africa, for four days of presentations, panel discussions and networking.?We are delighted to be supporting this event as?an Association Partner which enables TOPRA members to get 20% discount on registration fees.

Bursaries for training and development

We offer bursaries to support the training and development needs of regulatory affairs professionals in low-to-middle income countries. We currently offer two types of bursary: Education Bursaries for individuals at the start of their regulatory affairs careers; and 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.

Training opportunities in September and October

Wherever you are in your regulatory affairs career, our comprehensive range of training courses will help you take the next step. You will hear from expert speakers, gain knowledge from interactive exercises, and get essential networking opportunities. Upcoming courses in September and October include:

• CRED Getting the CMC Dossier Right (in-person on 4-5 September)
• Registering Biological Biotech & Advanced Therapy Products Masterclass (in-person or online on 9-11 September)
• CRED Successful and Skilful Communication (in-person on 24 September)
• CRED An Overview of Regulatory Product Information (in-person or online on 25 September)
• Regulatory Strategy from Development to the Marketplace Masterclass (in-person or online on 7-9 October)
• Essentials of European Pharmaceutical Regulatory Affairs (in-person or online on 14 October)
• CRED Understanding Clinical Development (in-person on 15 October)
• Post-Market Surveillance and Vigilance for Medical Devices Masterclass (in-person or online on 23-25 October)

Join TOPRA

As the leading global membership organisation for professionals in regulatory affairs, we help thousands of TOPRA members unlock their potential. We can do the same for you too.

Here are 5 great reasons to become a TOPRA member today!

?Enjoy great savings on our events and training

?Get involved with our networks

?Contribute to the profession

?Grow your skills and knowledge

?Take your career to the next level

We look forward to welcoming you to our dynamic international community!