Keeping oversight of safety for Clinical Project Managers
About this course
Reasons to attend
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.Programme highlight
- 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
Learning objectives
- 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
- Safety Physicians
- Clinical Research Associates
- Regulatory Affairs Specialists
- Biotech/Pharmaceutical Professionals involved in clinical trials.
- Overview of clinical research processes and regulatory requirements
- Knowledge of Good Clinical Practice (GCP)
- Awareness of the ethical principles involved in clinical trials.
Competencies
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)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
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