Keeping oversight of safety for Clinical Project Managers

This Keeping oversight of safety course is mainly intended for Clinical Project Managers however the following functions may also benefit from it:

• Clinical Trial Sponsors
• Safety Physicians
• Clinical Research Associates
• Regulatory Affairs Specialists
• Biotech/Pharmaceutical Professionals involved in clinical trials.

Attendees should have prior knowledge of:

• Overview of clinical research processes and regulatory requirements
• Knowledge of Good Clinical Practice (GCP)
• Awareness of the ethical principles involved in clinical trials.

Having prior knowledge in these areas will allow attendees to fully understand the key concepts and practices covered in the training and provide a foundation for the development of effective pharmacovigilance strategies.

Please note that this course is pitched at CPMs who are earlier in their pharmacovigilance journey — those with extensive PV experience may find the content familiar.

Course Long Description

As a Clinical Project Manager, it's crucial to keep the safety of trial participants a top priority. This responsibility includes monitoring the benefit-risk balance of the product being tested. To help you stay up to date on pharmacovigilance regulations, we're offering a comprehensive training program, "Keeping Oversight of Safety for Clinical Project Managers." This training covers the obligations for clinical trial sponsors conducting trials in Europe, both during the development phase and post-approval safety studies.

The training covers key aspects of pharmacovigilance, including monitoring safety, reporting and documenting adverse events, and communicating safety information. Our experienced trainers will provide hands-on experience in developing and implementing effective pharmacovigilance strategies and procedures. This training is ideal for both new and experienced Clinical Project Managers, as it will deepen your knowledge and skills in the field.

The European Clinical Trial Directive 2001/20/EC, GCP Directive 2005/28/EC, the European Clinical Trial Regulation 536/2014, and Regulation (EC) No 726/2004, all play a crucial role in the continuous monitoring of the benefit-risk balance of investigational medicinal products in clinical trials. By attending this training, you'll leave with a clear understanding of your obligations in pharmacovigilance, and the confidence to implement best practices and standards in your clinical trials.

Investing in your professional development is essential for advancing your career in clinical trials. This training is a unique opportunity to deepen your knowledge in pharmacovigilance and Clinical Project Management. Sign up today and take the first step towards becoming an expert in the field.