AIMS SIG - Open-Source Lunch Bites
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.
On June 12th, 2023, the CIOMS (Council for International Organizations of Medical Sciences) Working Group XII1 published a draft guideline on Benefit-Risk Balance for Medicinal Products for Public Consultation, which the BRESIG took the opportunity to review. We successfully submitted our feedback by the deadline of July 24th, 2023.
The long-awaited guideline is close to the BRESIG’s heart as it covers a variety of topics discussed within the group, and is central to our work within the (bio-)pharmaceutical industry. CIOMS guidelines are often cited and form the basis of many ICH (International Council for Harmonisation) guidelines.2
We are looking very much forward to finalization of this guideline because it provides an excellent overview of the elements of benefit-risk assessment that have been discussed in recent years in the literature and among practitioners. Therefore it is a perfect read for people newly interested but also for those following up on the topic. Notably valuable is a section including case studies.
[1] https://cioms.ch/working-groups/working-group-xii/
[2] https://cioms.ch/cioms-guidelines-served-basis-many-ich-guidelines/
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.
Date: Ongoing 6 month cycle beginning late April/early May 2026 Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event! Haven’t read the book yet? Pick up a copy today and join us. Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation. The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication. The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication. The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.
We’re seeking a dynamic and visionary leader to join us as Head of Projects - a pivotal role with full ownership of our Projects Division.
We are looking for Senior Statistical Programmers in the UK to join Veramed, where you'll deliver high-impact programming solutions in an FSP-style capacity, while advancing your career in a supportive, growth-driven environment.