08 Nov 2018: Be Audit Proof, Always!
As a clinical researcher, you should always be ready for an audit. This TRIUM training will uncover the secret to become ‘audit proof’ at any time.
The only evidence for regulatory compliance whiles ensuring subject safety and well-being and quality data are the essential – and source documents related to the clinical trial. After an introduction on audits, expectations and behaviors, a practical session using a real TMF will follow. The trainer, who is also an auditor in real life, will review the TMF together with the participants whiles acting and asking questions as if she was auditing. Participants will learn hands-on how the documents need to be aligned and ‘tell the story’ of the trial to any stakeholder.
22 Nov 2018: The Sunshine Act: Where Applicalbe and How to Ensure Compliance?
Many stakeholders expressed concerns about the influence the pharmaceutical or device industry has over healthcare actors including healthcare professionals and organizations, families, patients, service providers and the public. Up until a few years ago, there was little regulation governing these relationships and Pharma/Device companies did not need to disclose whether they, for example, sponsored events or made transfers of value (i.e. donations, gifts etc.) to healthcare professionals and organizations.
Following the introduction by the US of the ground-breaking Physicians Payments Sunshine Act in 2010, the transparency landscape has rapidly shifted in Europe.
This TRIUM training provides a map as created by the Mental Health Europe (MHE) organization © 2017, which aims to give a glimpse into the situation in Europe where many countries have introduced Sunshine Laws, Regulations and Rules which require transparency around ‘transfers of value’ between Pharma and healthcare professionals. The legislation and rules adopted vary from regulations to attempts at better self-regulation from Pharma and the healthcare profession through the adoption of voluntary Disclosure Codes (which are not mandatory to follow). A brief introduction of what country has a Sunshine Act regulation or not, and if not, what Codes are followed and their requirements will be the core of this session, enabling you to ensure compliance when conducting trials in Europe.
26 Nov 2018: Presentation Skills: Becoming an Exceptional Presenter
No, presenting is not just about having great slides. They can’t make up for a bad presenter, but reversely an exceptional presenter can make up for not so fancy slides.
Presenting is a key skill for any professional, so no different for a clinical researcher. No matter what role or level of experience, as a researcher you are often to present early on in your career to train staff or peers or to present trial results, amongst others. Many however feel nervous and anxious about the foresight of delivering a presentation.
We cannot promise to take away all your fears unfortunately. However, this TRIUM Training will help you control your feelings by providing a proven formula to OPEN UP! and own the room, based on the book ‘The Exceptional Presenter’ by Timothy J. Koegel (2007 ©). It takes the mystery and the misery out of presenting by breaking down the art of presenting into a series of skills and by providing a systematic formula to master each skill. As a result, you will learn how to develop a presentation style that is organized, passionate, engaging, natural and that is in line with your specific audience’s needs. And your slides, well – they need to support the presenter.
After a theoretical introduction to the skills and techniques you will have opportunity to practice and learn from you peers. A handy job aid summarizing the key take-aways will be handed out at the end of the training day to help you transform your newly learned skills into actual performance.