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The Master Class in Pharmacovigilance, led by expert Amer Alghabban, aims to equip participants with essential skills and knowledge for a career in drug safety. The course covers theoretical foundations, practical skills, and regulatory insights, culminating in a recognized certification. It is designed for a diverse audience, including recent graduates, healthcare professionals, and those looking to advance or shift their careers in pharmacovigilance.

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8 views7 pages

Basic Classroom Worksop

The Master Class in Pharmacovigilance, led by expert Amer Alghabban, aims to equip participants with essential skills and knowledge for a career in drug safety. The course covers theoretical foundations, practical skills, and regulatory insights, culminating in a recognized certification. It is designed for a diverse audience, including recent graduates, healthcare professionals, and those looking to advance or shift their careers in pharmacovigilance.

Uploaded by

adityavbhushan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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ENABLING THE FUTURE

Master Class in Pharmacovigilance

LAUNCHING YOUR CAREER IN


DRUG SAFETY

11th - 13th June

Amer Alghabban
Managing Director and
Founder of (GCTP) Ltd
PhD, Clinical Pharmacologist,
GxP Expert

Call Us Visit Our Website


+91 7483349604 www.feconnect.world
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.

Testimonials
1. "Amer's training sessions are not only informative but also engaging. He breaks down
complex regulations into manageable parts, making it easier for everyone to grasp. His
deep knowledge and practical insights make him a standout educator." - John Doe, Senior
Manager, Pharma Inc.
2. "Attending Amer's pharmacovigilance course was a turning point in my career. His expertise
and approachable teaching style have greatly enhanced my understanding of drug safety." -
Jane Smith, Clinical Research Coordinator
3. "Dr. Alghabban's workshops are meticulously organized, reflecting his vast experience and
commitment to quality. His sessions on GVP regulations were particularly enlightening and
directly applicable to my work." - Carlos Ramirez, QA Specialist
INTRODUCTION
Welcome to the Master Class 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 BENEFITS
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.
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.

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