Ongoing Clinical Trials which are approved in EU region and registered in EudraCT have to be analyzed if a transition to the EU central database via the new portal CTIS (Clinical Trial Information System) is necessary. A potential transition to CTIS needs to be completed by 31 Jan 2025 for all those ongoing trials lasting longer than this date. 

Based on this urgent need, we have designed a training to provide Pharma, Biotech and CROs with guidance for an efficient and smooth transition process to CTIS.

During this 4 hour online course, you will get further insights into the process of transition, relevant timelines, and you will receive helpful hints to develop tools and a transition roadmap for your trials. This course could also be delivered in a customized way according to your wishes, which could include face 2 face training in your organization.

If you are interested or have any questions, please contact us by email or by phone - We are happy to provide you with further information, insights and details.

The 8-hour training on the Clinical Trial Regulation (CTR) 536/2014 provides comprehensive education on conducting clinical trials within the European Union (EU) and is designed for operational experts in clinical development. 

The course begins with a detailed introduction to the CTR and its significance in pharmaceutical research and development in the EU. 

The training content includes practical guidance on implementing CTR requirements, such as registering studies in Clinical Trial Information System (CTIS) and provides further insight into the timelines of the whole process and explains all necessary steps of the submission process that need to be considered from a Sponsors/CRO point of view. 

The training concludes with a summary of key takeaways and resources for further information and support. Its aim is to prepare participants for the effective execution of clinical trials in accordance with CTR 536/2014 and ensure compliance with the regulation.

This course could also be delivered in a customized way according to your wishes, which could include face-to-face training in your organization or can be provided as face-to-face training at a location of your preference.

If you are interested or have any questions, please contact us by email or by phone - We are happy to provide you with further information, insights and details.

This 8-hour online or face-to-face fundamental training on operational procedures in pharmaceutical development is designed for newcomers in the clinical development or as a re-fresher for people who re-join the pharmaceutical industry.

The training provides a comprehensive overview of key concepts and processes in the clinical research area. Starting with an introduction to the fundamentals of pharmaceutical development, including phases of clinical trials and regulatory requirements, it fosters an understanding of the roles of various stakeholders from phase I – IV clinical trials. It covers essential steps and requirements for planning, conducting, reporting and monitoring clinical trials, encompassing topics such as protocol design, patient recruitment, data management, and quality control. Additionally, ethical, and regulatory aspects are discussed, including compliance with Good Clinical Practice (GCP) and ethical guidelines. 

The training concludes with a summary of key learning points and resources for further information. Its objective is to provide participants with a solid understanding of operational procedures in pharmaceutical development and prepare them for their key functions in this field.

This course could also be delivered in a customized way according to your wishes, which could include face-to-face training in your organization or can be provided as face-to-face training at a location of your preference.

If you are interested or have any questions, please contact us by email or by phone - We are happy to provide you with further information, insights and details.

Knowledge of the ICH-GCP guidelines is one of the basic requirements when conducting clinical trials and is a mandatory training for clinical professionals and investigational site staff.

With this virtual or classroom course you will receive a role specific basic training covering all ICH-GCP relevant aspects as a full day training course or as a half day re-fresher course.

In this 4 or 8-hour basic or refresher training course, we will provide you with all the content you need for your daily ICH-GCP related activities. In addition to the history and regulatory requirements, we will cover the various roles and definitions as well as the oversight activities required by ICH-GCP.  

At the end of the training, you will conduct a written knowledge assessment to prove your ICH-GCP knowledge before you will receive a certification for the training.

Depending on your needs the training can also be provided as a customized training focusing on the main aspects of your daily ICH-GCP interaction for your internal team only or as a classroom training at a location of your preference.

If you are interested or have any questions, please contact us by email or by phone - We are happy to provide you with further information, insights and details.

An ISO 14155 training is essential for professionals in the medical device industry to understand the regulatory requirements and ensure that clinical trials adhere to ethical and scientific standards. 

This 4-hour online training covers an introduction to the basics of the regulation, as well as detailed information on requirements for study design, conduct, monitoring, and documentation of clinical trials. It also explains the importance of quality management and risk management in this context. Emphasis is placed on ensuring the safety and well-being of study participants and the integrity of the data collected. Additionally, best practices for working with ethics committees and regulatory authorities are provided. The ISO 14155 training aims to deepen understanding of regulatory requirements and improve compliance to conduct high-quality and ethically sound clinical trials.

Depending on your needs the training can also be provided as a customized training only for your internal team or as a class room training at a location of your preference.

If you are interested or have any questions, please contact us by email or by phone - We are happy to provide you with further information, insights and details.

Clinical development is becoming increasingly complex, so we have developed a training course for one of the key functions (the project manager), which is designed to appeal to new and experienced project managers.

With this course you will be able to improve and strengthen the project management skills, whether you are an experienced or still junior project manager.

In this 8-hour face-to-face training course, we will give you an insight into the necessary hard skills as well as soft skills required to be a successful project manager. You will learn during a case study with many real-life examples the impact of the latest regulations and how to manage and mitigate risks. The training will also show you potential tools and inspiration for improving your study documentation. 

Depending on your needs the training can also be provided as a customized training only for your internal team or as a classroom training at a location of your preference.

If you are interested or have any questions, please contact us by email or by phone - We are happy to provide you with further information, insights and details.