Keeping oversight of safety for Clinical Project Managers
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|24/10/2023||Keeping oversight of safety for Clinical Project Managers||Webinar||EUR 425.00||Book|
|If you would like to have this course as an in-house session click here|
About this course
This training program covers pharmacovigilance obligations in clinical trials conducted in Europe. It provides hands-on experience in implementing effective pharmacovigilance strategies, and covers key regulations and directives. The training deepens knowledge and skills in ensuring the safety of trial participants. Attendees will leave with a clear understanding of their obligations in pharmacovigilance.
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.
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