Immunotherapy and advanced biologics are transforming modern medicine by providing innovative treatment options for cancer, autoimmune diseases, and other chronic conditions. These therapies harness the body’s immune system or utilize cutting-edge biologics to deliver highly targeted and effective interventions. For pharmacists, understanding the science, application, and regulatory frameworks of immunotherapy and biologics is crucial to delivering safe, effective, and patient-centered care. This training course equips healthcare professionals with the expertise to integrate these advanced therapies into pharmacy practice while ensuring adherence to clinical and regulatory standards.

The program combines theoretical foundations with practical applications, covering areas such as monoclonal antibodies, checkpoint inhibitors, CAR-T cell therapy, biosimilars, patient monitoring, and pharmacovigilance. Participants will gain insights into the clinical use of advanced biologics, explore global best practices, and develop skills to manage complex treatment regimens. By the end of the course, attendees will be empowered to support innovative therapy delivery, improve patient outcomes, and contribute to advancing pharmaceutical care.

Duration: 10 Days

Target Audience

• Clinical pharmacists and hospital pharmacists
• Pharmacists specializing in oncology and immunology
• Pharmaceutical researchers and scientists
• Physicians and healthcare professionals working with biologics
• Regulatory affairs and compliance officers
• Academics and postgraduate pharmacy students
• Policy makers in pharmaceutical regulation
• Nurses and healthcare providers in immunotherapy units
• Biotechnology and pharmaceutical industry professionals
• Consultants in advanced pharmaceutical care

Objectives

• Understand the principles of immunotherapy and biologics
• Explore the mechanisms of monoclonal antibodies and targeted therapies
• Gain knowledge in CAR-T cell therapy and novel immunotherapies
• Strengthen skills in patient-centered biologics management
• Learn about biosimilars and their regulatory pathways
• Enhance pharmacovigilance and safety monitoring in biologics use
• Apply evidence-based approaches to advanced therapies
• Examine ethical, legal, and social considerations in immunotherapy
• Study global case examples of advanced biologics integration
• Build institutional capacity for innovation in pharmacy practice

Course Modules

Module 1: Introduction to Immunotherapy and Biologics

• Evolution of biologics in healthcare
• Principles of immunotherapy
• Types of advanced biologics
• Role in pharmacy practice
• Global perspectives

Module 2: Monoclonal Antibodies in Therapy

• Mechanisms of monoclonal antibodies
• Clinical applications in oncology
• Autoimmune disease treatment
• Safety and efficacy considerations
• Case studies in pharmacy practice

Module 3: Checkpoint Inhibitors and Cancer Therapy

• Immune checkpoint pathways
• Common checkpoint inhibitors
• Clinical evidence in cancer treatment
• Monitoring therapy responses
• Adverse effect management

Module 4: CAR-T Cell Therapy

• Principles of CAR-T cell technology
• Clinical applications and approvals
• Manufacturing and administration processes
• Patient monitoring requirements
• Case examples of CAR-T use

Module 5: Advanced Biologics for Autoimmune Diseases

• Role of biologics in rheumatoid arthritis
• Psoriasis and dermatological applications
• Inflammatory bowel disease therapies
• Biologics in multiple sclerosis
• Case-based applications

Module 6: Biosimilars and Pharmacy Practice

• Definition and development of biosimilars
• Comparability to reference biologics
• Regulatory approval pathways
• Role of pharmacists in biosimilar adoption
• Global case studies

Module 7: Pharmacokinetics and Pharmacodynamics of Biologics

• ADME properties of biologics
• Differences from small-molecule drugs
• Immunogenicity challenges
• Dose optimization strategies
• Clinical implications

Module 8: Patient-Centered Care in Immunotherapy

• Counseling patients on advanced biologics
• Shared decision-making approaches
• Monitoring adherence and outcomes
• Managing side effects and toxicities
• Communication and trust building

Module 9: Pharmacovigilance in Immunotherapy and Biologics

• Safety monitoring frameworks
• Adverse event reporting systems
• Risk-benefit assessment
• Real-world evidence in safety monitoring
• Global pharmacovigilance practices

Module 10: Clinical Trials and Research in Biologics

• Phases of biologics clinical trials
• Trial design considerations
• Ethics in immunotherapy trials
• Data management and reporting
• Translating research into practice

Module 11: Manufacturing and Quality of Biologics

• Production of biologics and biosimilars
• Good Manufacturing Practices (GMP) requirements
• Quality assurance systems
• Lot release testing and validation
• Case studies in manufacturing

Module 12: Regulatory and Legal Frameworks

• Global regulations for biologics and immunotherapies
• FDA, EMA, and WHO guidelines
• Intellectual property and biosimilars
• Compliance challenges in biologics
• Harmonization initiatives

Module 13: Integration of Biologics into Healthcare Systems

• Reimbursement and pricing issues
• Access and equity challenges
• Role in public health strategies
• Integration into formularies
• Examples from global healthcare systems

Module 14: Ethical and Social Considerations

• Equity in access to biologics
• Informed consent in advanced therapies
• Addressing genetic and immunologic risks
• Social implications of biologic therapies
• Case discussions

Module 15: Case Studies in Pharmacy Practice

• Immunotherapy in oncology settings
• Biologics in chronic disease management
• Biosimilar substitution in pharmacy practice
• Pharmacist-led patient education programs
• Lessons from international best practices

Module 16: Future of Immunotherapy and Biologics

• Next-generation immunotherapies
• Role of precision medicine in biologics
• AI and digital health integration
• Global collaboration in biologics innovation
• Preparing for future advancements

 Training Approach

This course will be delivered by our skilled trainers who have vast knowledge and experience as expert professionals in the fields. The course is taught in English and through a mix of theory, practical activities, group discussion and case studies. Course manuals and additional training materials will be provided to the participants upon completion of the training.

Tailor-Made Course

This course can also be tailor-made to meet organization requirement. For further inquiries, please contact us on: Email: info@skillsforafrica.org, training@skillsforafrica.org Tel: +254 702 249 449

Training Venue

The training will be held at our Skills for Africa Training Institute Training Centre. We also offer training for a group at requested location all over the world. The course fee covers the course tuition, training materials, two break refreshments, and buffet lunch.

Visa application, travel expenses, airport transfers, dinners, accommodation, insurance, and other personal expenses are catered by the participant

Certification

Participants will be issued with Skills for Africa Training Institute certificate upon completion of this course.

Airport Pickup and Accommodation

Airport pickup and accommodation is arranged upon request. For booking contact our Training Coordinator through Email: info@skillsforafrica.org, training@skillsforafrica.org Tel: +254 702 249 449

Terms of Payment: Unless otherwise agreed between the two parties’ payment of the course fee should be done 7 working days before commencement of the training.