Pharmacovigilance, Drug Development Process, Aggregate Reports, Reporting Adverse Events, PSUR, DSUR, PADER, RMP.
What you will learn
Brief history of Pharmacovigilance & Drug development process.
Terminologies in Pharmacovigilance.
Pharmacovigilance Regulations & Guidelines.
Sources of Adverse event & Assessing Adverse Event Reports.
Reporting adverse events & Aggregate reports in Pharmacovigillance.
Responsibilities of Marketing Authorization Holder & Consequences of Non Compliance
Why take this course?
🎉 The Complete Pharmacovigilance Course: Become a Professional 🔬
Hello, Aspiring Pharmacovigilance Expert!
Are you poised to step into the dynamic world of drug safety and pharmacovigilance? Look no further! Our Complete Pharmacovigilance Course is your key to unlocking a rewarding career in this vital field. This course is not just an educational journey; it’s a deep dive into the science of monitoring drug safety, a discipline critical to protecting patient health and ensuring medication safety.
🌟 Course Highlights:
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- Comprehensive Coverage: Master the principles and practices of pharmacovigilance with a focus on regulations and guidelines that govern this field.
- Industry-Relevant Skills: Gain practical insights that align with real-world applications in drug development, adverse event reporting, and risk management.
- Expert Instruction: Learn from Dr. Mohd Aijaz, a seasoned professional with over 15 years of experience and a track record of scholarly contributions to pharmaceutical sciences.
- Career Advancement: Elevate your career prospects with an industry-recognized certification that sets you apart in the healthcare and pharmaceutical sectors.
Why Choose This Course?
This is the perfect course for:
- Students aiming to specialize in pharmacovigilance or related fields.
- Healthcare Professionals looking to expand their expertise in drug safety.
- Career Changers transitioning into the dynamic field of pharmacovigilance.
Who is the Trainer?
Your course is led by Dr. Mohd Aijaz, an expert with a wealth of knowledge and practical experience in the realm of pharmacovigilance. With over 15 years of industry involvement, he has authored ten books, secured five patents, and contributed to 70 research publications in pharmaceutical sciences. His expertise spans ICSRs (Individual Case Safety Reports), aggregate reports, signal detection, and risk management strategies.
Course Curriculum:
- Introduction to Pharmacovigilance: A primer on what the field encompasses and its significance in drug safety.
- History of Pharmacovigilance: Understanding the evolution and current state of pharmacovigilance.
- Drug Development Process: Insight into the lifecycle of a drug from development to post-marketing surveillance.
- Terminologies and Definitions: Clarity on the key terms used in pharmacovigilance.
- Pharmacovigilance Regulations & Guidelines: An overview of global standards and their implications for your work.
- Marketing Authorization Holder Responsibilities: Understanding the obligations of companies marketing pharmaceutical products.
- Consequences of Non-Compliance: Learning about the potential legal and financial repercussions of not adhering to regulations.
- Sources of Adverse Event Reports: Exploring where adverse event data is sourced from.
- Assessing and Reporting Adverse Events: Techniques for evaluating reports and ensuring accurate and timely reporting.
- Dossier Challenges / Rechallenges: Understanding the regulatory processes for assessing the risk of a medicine in relation to its benefits.
- Aggregate Reports (PSUR, DSUR, PADER): Mastering the preparation and submission of periodic safety update reports.
- Risk Management Plan (RMP): Developing a comprehensive plan to proactively manage risks associated with pharmaceutical products.
- Signal Detection: Learning how to identify potential signals in adverse event data that could indicate a drug safety issue.
By the conclusion of this course, you will be equipped with the knowledge and skills necessary to excel in the field of pharmacovigilance. You’ll be prepared to navigate the complexities of drug safety and contribute to ensuring the well-being of patients across the globe. We wish you great success as you embark on this transformative educational journey. 🎓
Good luck, and we look forward to welcoming you to the world of pharmacovigilance!
