This Keeping oversight of safety 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.
Overview of pharmacovigilance and the principles of monitoring safety in clinical trials
Explanation of the Clinical Trials Directive 2001/20/EC, GCP Directive 2005/28/EC, European Clinical Trial Regulation 536/2014, and Regulation (EC) No 726/2004 in relation to product safety
In-depth understanding of adverse event reporting and documentation requirements
Hands-on experience in implementing effective pharmacovigilance strategies and procedures
Discussion of best practices for communication of safety information to relevant stakeholders
Outline the key principles of pharmacovigilance in clinical trials
Recognise the relevant regulations and directives in Europe for the continuous monitoring of the benefit-risk balance of medicines
Apply strategies and procedures for effective pharmacovigilance in clinical trials.
Who should attend
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
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.
This course covers competencies that are part of the ECCRT Competency Framework
Scientific Concepts & Research Design (0)
Ethical & Participants Safety Considerations (8)
Investigational Product Development and Regulation (0)
Clinical Studies Operations (GCPs or ISO 14155) (6)
Study and Site Management (1)
Data Management and Informatics (1)
Leadership and Professionalism (0)
Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained
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