The understanding about risk management in PV
Risk management in pharmacovigilance is essential for ensuring the safety and well-being of patients by identifying, assessing, and mitigating potential risks associated with medications. Understanding the different approaches to risk management between regulatory agencies like the FDA and EMA is crucial for professionals in this field. While both agencies aim to protect public health, they may have varying requirements and methodologies for monitoring and managing risks. A deep knowledge of these differences allows for better compliance, more effective risk minimization strategies, and ultimately, improved patient safety across global markets.
What You'll Gain:
In this comprehensive course, you will dive deep into essential tools for decision-making in pharmacovigilance, including REMS for the US market and RMP writing for the EU. Through active, hands-on learning, you will engage in practical exercises, independent research, and quizzes designed to reinforce your understanding. With over 21 videos and 3.5 hours of video material, this course will solidify your expertise in risk communication and provide you with the skills to navigate the complexities of both FDA and EMA requirements effectively.
Who It's For:
This course is designed for professionals in the pharmaceutical industry with some prior experience, who are now facing the challenge of implementing risk management strategies. It's particularly valuable for medical writers or individuals responsible for overseeing risk management and communication, including those tasked with writing REMS for the US or RMPs for the EU.
Whether you're stepping into a new role or enhancing your expertise, this course will provide the in-depth knowledge and practical skills needed to excel in risk management within the pharmaceutical sector.
Curriculum
Success is in your hands!
This course is designed to increase competency! Thus, it is more than watching videos.
The course includes active tasks for you. The more you are doing proactively, the more wins you will have.
Your Instructor
More than 20 years of experience in the field of clinical trials and post-marketing of medicinal products. Worked as CRA, Trial Site Manager, and Drug Safety Manager for global clinical trials and post-marketing of various indications and patient age groups. Since several years working as EU&UK-Qualified Person for Pharmacovigilance and as such overseeing product lifecycle of medicinal products, supplementals, medical devices as well as working as local PV responsible person for DACH region. Supporting audit and inspections, Quality Assurance, Regulatory Affairs, Manufacturing, and Marketing. Experienced in several databases and European pharmaceutical law. Providing training for FORUM Institut about Audits&Inspections, Risk Management, GVP, and Clinical Trials.
She is founder and owner of ARC-Traicoa, a German company specialised in providing support in all aspects of pharmacovigilance.
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