CR015 Good Pharmacovigilance Practices, GXP Environment and Regulatory Enforcement

CR015 Good Pharmacovigilance Practices,
GXP Environment and Regulatory Enforcement

CR015 Good Pharmacovigilance Practices, GXP Environment and Regulatory Enforcement

CCCEP Number: 1684-2022-3542-L-P

This course is accredited for pharmacists in Canada as per the CCCEP requirements and has been accredited by the CCCEP for 7 CEUs. The Canadian Council on Continuing Education in Pharmacy (CCCEP) is a national organization established to accredit continuing pharmacy education programs intended to be delivered to pharmacy. CCCEP accreditation is recognized by the pharmacy regulatory authorities in all provinces and territories of Canada.

This course is designed to provide students with a comprehensive understanding of the regulatory framework, ethical considerations, and principles of good pharmacovigilance practices (GVP) in drug development and post-marketing surveillance. The course will cover the laws and regulations governing drug safety and pharmacovigilance in North America and globally.

We are proud to offer an accredited course for pharmacists in Canada, fulfilling the Canadian Council on Continuing Education in Pharmacy (CCCEP) requirements. This course, recognized across all provinces and territories in Canada, provides an extensive 7 Continuing Education Units (CEUs) as per CCCEP standards.

This comprehensive course is designed to immerse students in the world of pharmacovigilance, focusing on the regulatory framework and principles of Good Pharmacovigilance Practices (GVP) crucial in drug development and post-marketing surveillance. It covers a broad spectrum, from North American to global laws and regulations pertaining to drug safety and pharmacovigilance.

Key Learning Points:

Regulatory requirements for adverse event reporting, risk management plans, and post-marketing surveillance studies.
In-depth focus on GVP principles, emphasizing quality control, assurance, and the roles of various pharmacovigilance stakeholders.
Essential data management skills, ensuring accurate and complete documentation in study processes.

What You Will Learn:

By the end of this course, students will gain:
In-depth knowledge of the regulatory framework, ethical considerations, and GVP principles.
Practical skills to design and conduct clinical trials and post-marketing surveillance, ensuring regulatory compliance and patient safety.

Learning Objectives:

The course encompasses a variety of critical topics, including:

Understanding the GxP Environment and Good Practice Guidelines.
Comprehensive overviews of ICH Guidelines, Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP).
Detailed exploration of Good Pharmacovigilance Practices (GVP) and Risk Management.
Mastery in reporting practices, case analysis, and communication.
Skills to calculate incidence rates, manage safety signals, and conduct pharmacoepidemiologic studies.
Insights into registries, surveys, and safety monitoring.
Strategies for Risk Minimization.
An understanding of Regulatory Bodies in Canada, the US, and the EMA, and their role in GVP Enforcement.

Join us in this enlightening journey into the world of pharmacovigilance, and equip yourself with the knowledge and skills to make a significant impact in the field of pharmacy.

Registration Fee: $995+HST (CAD)

CR015 Good Pharmacovigilance Practices, GXP Environment and Regulatory Enforcement

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A Transformative Journey

The instructors are industry-experienced in a supportive learning environment. Field-related internships give students real-world experience. Students also receive ongoing job search assistance and career services from AAPS.

Sedigheh Fadaye Vatan

Pharmaceutical Quality Assurance and Regulatory Affairs Graduate

Taking the AAPS Cannabis Management, Quality & Laboratory course was the one of the best decisions for my career. They are all extremely knowledgeable in their field, with real life experiences to share.

Orenda Von Gernet

Cannabis – Management, Quality and Laboratory Graduate

I enrolled in the QA/QC program and midway through the program I successfully landed a 6-month internship at Teva Pharmaceuticals. Upon completing my program part-time, I got a full-time position with PerkinElmer.

Lukman Nahle

Pharmaceutical Quality Assurance and Quality Control Graduate

I am very happy that I chose AAPS as my next academic endeavor after graduating University. The course was very useful in teaching me the things that I will need to know when entering the Cannabis industry.

Zachary Petkov

Cannabis – Management, Quality and Laboratory Graduate

Coming to AAPS to pursue my PG Diploma in CRDSP has been one of the best career decisions. I’ve received my offer letter to join as Project Management Associate at Axiom real-time metrics solutions, On.

Remya Pushparajan Subha

Clinical Research Graduate

The food safety and quality program at AAPS provided me with the knowledge required for the Canadian food industry. As a newcomer to Canada, I really appreciated the welcoming vibe the college offered.

Dania Hariri

Food, Technology, Safety and Quality Graduate

I was newcomer in Canada from Nepal. I enrolled in PG Diploma in Pharmaceutical QC/QA/RA course which i think was the best. After 3 weeks of hard work into co-op days, I was offered a full-time job.

Yushma Shakya

Pharmaceutical Quality Assurance and Quality Control Graduate

I am excited to share my employment news. I am now working as Quality Assurance Manager and I couldn’t have done it without your help and encouragement. I want to specifically thank all the AAPS instructors.

Abolfazl Darashti

Food, Technology, Safety and Quality Graduate

Thank you to everyone at AAPS for helping me in my postgraduate training. I am now really excited to be working at the McKesson Corporation (Fortune Top 500 Company) as a Health Services Case Manager.

Amjad Atrash

Clinical Research Graduate

I am happy to share that I have received a job as a Clinical Research Recruiter at BioPharma Services Inc. It was a hard and persistent job but I couldn’t have done it without the AAPS support.

Saeeda Hasan

Clinical Research Graduate

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