Registration - Online Masterclass in Pharmacovigilance
Online Masterclass in Pharmacovigilance - Launching Your Career in Drug Safety
LIVE ONLINE TRAINING
11th -13th June 2025
Who is Your Trainer
AMER ALGHABBAN
Founder of (GCTP) Ltd PhD, Clinical Pharmacologist, GxP Expert
Amer Alghabban, PhD, Clinical Pharmacologist, GxP Expert
With over three decades of extensive experience in pre-clinical, clinical research & development, and pharmacovigilance operations, Amer Alghabban is a venerated figure in the pharmaceutical and biotech industries. As the founder and Managing Director of GxP Compliance & Training Partners (GCTP) Ltd., he has been instrumental in delivering expert Quality Assurance (QA), training, and regulatory compliance solutions across the globe.
Amer's expertise spans a comprehensive range of GxP services, including Good Clinical Practice (GCP), Good Vigilance Practice (GVP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and Good Distribution Practice (GDP). His proactive approach in managing over 160 regulatory authority inspections by major bodies such as the FDA, EMA, and others, showcases his deep commitment to upholding the highest standards of drug safety and regulatory compliance.
His career achievements include pioneering roles such as the first Pharmacovigilance Compliance Officer at the MHRA, where he conducted the first GCP-GVP inspection in the EU, illustrating his leadership in shaping regulatory practices
COURSE OVERVIEW
Welcome to the MasterClass in Pharmacovigilance – Launching Your Career in Drug Safety. This course is designed to equip you with the essential knowledge and skills necessary to excel in the dynamic and critically important field of pharmacovigilance. Whether you are a recent graduate aiming to enter the field, a professional seeking a career shift, or a current practitioner aiming to deepen your expertise, this course offers a structured path to mastering the complexities of drug safety monitoring.
Why Pharmacovigilance?
Pharmacovigilance is integral to the healthcare system, focusing on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. The overarching goal is to ensure that the benefits of a particular medication outweigh its risks. This field has gained significant prominence as regulatory agencies have intensified their demand for stricter monitoring and reporting practices, making pharmacovigilance a crucial career path for those interested in making a significant impact on public health.
What Sets This Course Apart?
Our Master Class goes beyond traditional learning paradigms by integrating real-world case studies, regulatory updates, and interactive sessions led by industry experts with decades of experience. You will engage in comprehensive training that covers:
- Theoretical foundations of pharmacovigilance.
- Practical skills in adverse event reporting and risk management.
- Insights into regulatory requirements and how to prepare for inspections.
Your Pathway to Expertise
By the end of this course, you will not only receive certification but also develop the confidence to handle complex pharmacovigilance tasks and make informed decisions that contribute to drug safety and efficacy. The knowledge gained here will prepare you for a variety of roles in the field, from safety data analysis to regulatory compliance and beyond.
Join Us
Embark on your journey to becoming a key player in the safeguarding of public health through effective drug safety practices. This course is your gateway to understanding the critical role pharmacovigilance plays in the lifecycle of pharmaceutical products and how you can contribute to this vital field.
This enhanced introduction aims to capture the attention of potential attendees by emphasizing the relevance and importance of pharmacovigilance in today’s healthcare landscape, the unique features of the course, and the tangible benefits of participation, setting the stage for an immersive educational experience.
KEY BENIFITS
Expert-Led Instruction: Learn from seasoned professionals, including Amer Alghabban, who bring over three decades of experience in pharmacovigilance and regulatory compliance. Their deep industry insights will help you navigate complex scenarios you’ll encounter in your career.
Comprehensive Certification: Upon completion, receive a certification that is recognized by industry leaders worldwide. This certification not only enhances your resume but also signifies your expertise and readiness to handle critical responsibilities in drug safety.
Networking Opportunities: Connect with peers, industry experts, and potential employers through interactive sessions and networking breaks. These connections can be invaluable as you progress in your career, providing support and opening doors to new opportunities.
Practical Skills Development: Engage in hands-on learning through case studies and real-world scenarios that ensure you can apply your knowledge effectively in your job. This practical approach helps bridge the gap between theory and actual job requirements.
Regulatory Insights: Gain up-to-date knowledge of global regulatory standards and expectations, including those from the FDA and EMA. Understanding these can significantly enhance your ability to contribute to your organization’s compliance and success.
Career Advancement: Armed with advanced knowledge and skills, you’ll be positioned to take on higher roles within your organization or the industry, driving your career forward with confidence.
What You Will Learn
Fundamentals of Pharmacovigilance: Start with the basics—what pharmacovigilance is, why it is crucial, and how it has evolved over time. Understand the key terms and concepts that are foundational to the field.
Adverse Event Reporting Systems: Dive deep into the systems used for reporting adverse events. Learn how to effectively capture, report, and follow up on adverse event data to ensure compliance and patient safety.
Signal Detection and Risk Management: Discover methods for detecting signals and managing risks associated with pharmaceutical products. Learn to use both qualitative and quantitative approaches to assess and mitigate risks.
Regulatory Compliance and Inspections: Prepare for global regulatory inspections by understanding what inspectors look for and how to maintain compliance with international standards. Learn about the documentation, processes, and audit trails that must be managed to pass inspections smoothly.
Advanced Pharmacovigilance Practices: Explore advanced topics such as pharmacogenomics, real-world evidence, and post-marketing surveillance. Understand how these areas are influencing the field and how they can be integrated into your pharmacovigilance strategy.
Career Opportunities in Pharmacovigilance: Discuss the various roles and career paths available within the field of pharmacovigilance. Learn what skills and experiences are required to succeed in each role and how to plan your career growth strategically.
WHO SHOULD ATTEND
This Master Class in Pharmacovigilance is meticulously designed to cater to a wide array of professionals, from those just embarking on their careers to seasoned experts seeking to enhance their skills and knowledge in the field:
- Recent Graduates and Students: This course is ideal for individuals who have recently graduated or are currently enrolled in medical, pharmacy, life sciences, or public health programs. It provides foundational knowledge and skills that are crucial for entering the field of pharmacovigilance and understanding the science of drug safety monitoring.
- Healthcare Professionals: Doctors, nurses, pharmacists, and other healthcare providers will benefit from learning about the adverse effects of drugs, how to report them, and the importance of monitoring drug safety. This knowledge is crucial for improving patient care and safety.
- Clinical Research Associates and Coordinators: Those involved in clinical trials will gain insights into the critical role of pharmacovigilance in the development and post-market surveillance of pharmaceuticals. The course offers practical knowledge on managing drug safety data and understanding regulatory requirements.
- Regulatory Affairs and Quality Assurance Personnel: Professionals working in regulatory affairs and quality assurance will find this course valuable for deepening their understanding of global drug safety regulations, compliance requirements, and best practices in pharmacovigilance.
- Pharmacovigilance Specialists: This course is perfect for entry-level and mid-level pharmacovigilance professionals who are looking to advance their career by gaining a deeper understanding of adverse event reporting, risk management, and regulatory inspections.
- Biotech and Pharmaceutical Executives: Senior executives and decision-makers in the biotech and pharmaceutical industries who are responsible for overseeing drug safety operations will benefit from advanced modules on strategic management of pharmacovigilance activities and aligning these with business goals.
- Policy Makers and Health Authorities: Individuals involved in policy-making or working for health authorities can enhance their understanding of drug safety to improve regulatory frameworks and promote safer pharmaceutical practices.
- Career Changers: This course also welcomes individuals from unrelated fields who are considering a career change into the health sector. It provides them with a comprehensive introduction to pharmacovigilance, helping them make informed decisions about their career paths.