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 Topics Include:

• 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.

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