Pharmacovigilance & Patient Safety

Pharmacovigilance offers a rewarding alternative, placing you at the forefront of public health. Your impact goes beyond just dispensing medications. It’s about ensuring patient safety on a public scale.

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Executive Summary

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before being authorized for use in clinical practice for treatment of patients. However, considering the controlled nature of clinical trials and the limited number of patients, some of safety related or efficacy concerns may only be observed in heterogeneous populations including with concomitant use with other products. It is therefore imperative to train and equip healthcare professionals with the requisite skills to be able to detect, assess, investigate, report and manage any adverse events associated with any medicines or vaccines in use across the developmental cycle to post-market use.

Pharmacovigilance specialists play a critical role in preventing harm from adverse drug reactions in humans arising from use of authorized medicinal products or from occupational exposure as well as promoting the safe and effective use of medicinal products. This is made possible through routine surveillance, monitoring, investigation and resolution of any adverse events attributed to or suspected to be associated with any medicinal products and providing timely information to influence the use as per the risk-benefit profile. These interventions contribute to optimal healthcare service delivery by fostering rational use of medicines while reducing the harm associated with the same.

Pharmacovigilance specialists practice in various settings ranging from biopharmaceutical companies, research consortiums, clinical research organizations (CROs), national pharmacovigilance centers, academic institutions, regulatory agencies and development partners among others.

This course is designed to equip learners with skills and competencies required for the performance of pharmacovigilance functions ranging from: pharmacovigilance surveillance, reporting, processing of case safety reports, aggregate reporting, managing product risk management & pharmacovigilance master files, perform causality assessment and among other PV functions.

Course Objectives

To promote understanding of basic principles of pharmacovigilance with focus on practice in the biopharmaceutical industry spanning pharmaceuticals, medical devices, clinical trials, policy and research.
To equip learners with skills and competencies to execute pharmacovigilance functions in the biopharmaceutical industry.
To enable learners to apply knowledge and skills in pharmacovigilance in industry, clinical and regulatory settings.
To spotlight the critical role of pharmacovigilance towards the realization of universal healthcare coverage (UHC).
To expose graduates to career opportunities in pharmacovigilance and patient safety.

Course Structure

Core Lectures

Guest Lectures

Case Presentations

Mode of Delivery & Duration

The program will be delivered virtually on Microsoft Teams.

The course runs for 12 weeks. Each session will run for 2hrs weekly.

Modules

Introduction to Pharmaceutical Supply Chain Management – covering scope of pharmaceutical supply chain management, the need and principle of essential health products.
Product Selection – focused on understanding approaches to product selection, development of product specifications, product range optimization and product selection criteria.
Demand/Supply Planning, Forecasting & Quantification – with focus on needs assessment, understanding quantification and forecasting methods, and the challenges in demand planning & quantification.
Procurement – understanding procurement methods, procurement process management, supplier selection, contracting & contract management, monitoring & evaluation, procurement performance improvement plans and Good Procurement Practices (GPP) including laws & policies on procurement.
Warehousing & Inventory Management – understanding site selection, warehouse design & management protocols, product security & inventory control methods, warehouse equipment & layout and Good Warehousing Practices (GWP).
Logistics Management – understanding the goals of storage and distribution, traceability and product visibility across the supply chain, product integrity on transit, logistics planning, reverse logistics grounded on Good Distribution Practices (GDP).
Product Use – understanding the concept of rational use of health products and technologies, dispensing practices, assessment of product use and product use improvement plans management.
Resource Management (Financial, Personnel, IT) with focus on understanding Financial Planning & Management (Budgeting, Budget Monitoring, Costing & Pricing of Products, Economic Evaluation of Products); Human Resource Management (Recruitment, In-Service Training, Performance Management & Appraisals and Policies/Job Descriptions/Specifications); Digital Health Technologies & Data Analytics (IT Systems Needs Assessment, Procurement, Deployment & Use – Data Integrity & Security; Systems Interoperability & Compatibility) and Equipment & Tools: Maintenance, Calibration, Handling & Access Rights.
Monitoring & Evaluation of Pharmaceutical Supply Chain Management geared at understanding supply chain performance indicators, reporting, logistics information management systems & tools, audits & inspections management, data sources & means verification and stakeholder management.
Quality Management Systems: QA, QC, Audits & Risk Management – understanding principles of Pharmaceutical Supply Chain Management Process Optimization, Good Documentation Practices, Pharmacovigilance Principles and Patient Safety, Regulatory Affairs, Quality Assurance, Quality Control, Quality Audits, Change Management and Pharmaceutical Waste Management.
Leadership in Pharmaceutical Supply Chain Management with focus on team management and vision setting, industry influencing & agenda setting, personal branding, pharmaceutical supply chain leadership priority setting in corporate organizations, and change management.

Target Participants

Professionals working in or with an interest in pharmaceutical & healthcare supply chain management.

Prerequisite: basic understanding of health systems principles.

Why Should You Enroll?

Get the skills to venture into a rewarding career.
An opportunity to redefine health product security in Africa through policy, strategic and operational interventions.
Gain insights into critical supply chain principles in the pharmaceutical and healthcare sector.
Get exposed to global trends and networks in the health supply chain.

Course fees

Members: USD. 250

Non-members: USD. 300

Enroll now

Course Faculty

Dr. Kennedy Odokonyero Pharmacovigilance Consultant

Odokonyero has over half a decade of hands-on experience in Good Pharmacovigilance Practices (GVP) and Quality Management Systems (QMS). He works with local and international organizations where he supports in development and optimization of their pharmacovigilance and quality management systems. He has served as a consultant at the East Africa Pharmacovigilance Initiative and recently supporting in the development of a “Guide to Developing a Pharmacovigilance Course Curriculum for Health Professional Training Institutions in Uganda.” He is keen to connect with like-minded professionals and organizations to harness shared dedication to elevating quality and patient safety.

Dr. Asava Benson pharmacovigilance professional

Dr. Asava is an experienced pharmacovigilance professional with extensive experience in drug safety and regulatory compliance. He is skilled in advanced skill in case handling, adverse event management, risk assessment. and well experienced in managing pharmacovigilance databases. He is dedicated to maintaining the highest standards of patient safety and regulatory compliance.

Dr. Mochache Felix QPPV Specialist

Dr. Mochache is the pharmacovigilance team lead and qualified person for pharmacovigilance at one of the leading multinational companies in Kenya. He is responsible for a cluster of countries in East and Southern Africa. He is a pharmacist by training and is currently pursuing a Masters in Public Health. He has 8 years of professional experience, 6 of which he has fully practiced in pharmacovigilance. He has also worked briefly in quality assurance and regulatory affairs and is an active member of several professional and local industry groups.

Pharmacovigilance Alumni

"The Pharmacovigilance and Patient Safety Course by APN provided me with cutting-edge knowledge and practical skills to significantly enhance patient safety in healthcare."

"The Pharmacovigilance and Patient Safety course by APN has been seamless, engaging, and expertly delivered, equipping me with invaluable skills to advance my career and contribute to safer patient care—highly recommended for pharmacists seeking to enhance their expertise."

"The Pharmacovigilance and Patient Safety course with the African Pharmaceutical Network honed my skills. The knowledge gained on safety reports, risk management, and inspections will help me develop the British Virgin Islands' pharmacovigilance system. It was 12 weeks well spent. Thank you, APN!"

"Completing APN's Pharmacovigilance and Patient Safety course was a transformative career decision, offering expert-led, engaging sessions that deepened my understanding, ignited my passion, and equipped me to positively impact patient safety—highly recommended!"