The global pharmaceutical industry is rapidly advancing with the growth of biopharmaceuticals and biosimilars, transforming treatment options for a wide range of diseases. These innovative therapies provide high efficacy and targeted approaches but also require rigorous development and regulatory oversight to ensure quality, safety, and effectiveness. This training course equips participants with comprehensive knowledge of the scientific, technical, and regulatory aspects of biopharmaceutical and biosimilar development, preparing professionals to navigate complex global requirements.

The program combines theory with real-world applications, covering areas such as biologics development, biosimilar comparability, Good Manufacturing Practices (GMP), clinical trial design, regulatory submissions, and post-market surveillance. Participants will engage with case studies and hands-on exercises to gain practical insights into the lifecycle of biopharmaceuticals and biosimilars. By the end of the course, attendees will be empowered to contribute to innovative drug development while ensuring compliance with stringent regulatory frameworks.

Duration: 10 Days

Target Audience

• Biopharmaceutical scientists and researchers
• Regulatory affairs professionals
• Quality assurance and compliance officers
• Pharmacists in biotechnology and clinical practice
• Clinical trial managers and coordinators
• Policy makers in pharmaceutical regulation
• Intellectual property and legal experts in pharmaceuticals
• Academics and postgraduate students in biotechnology
• Manufacturing and process development professionals
• Consultants in biopharmaceutical development and regulation

Objectives

• Understand the fundamentals of biopharmaceutical and biosimilar development
• Explore regulatory frameworks for biologics and biosimilars
• Learn techniques for comparability and characterization
• Strengthen knowledge of GMP in biopharmaceutical manufacturing
• Gain expertise in clinical trial design for biosimilars
• Prepare regulatory submissions and manage approvals
• Address challenges in pharmacovigilance and risk management
• Analyze intellectual property considerations for biosimilars
• Study case examples of global biosimilar approvals
• Build institutional capacity for innovation and compliance

Course Modules

Module 1: Introduction to Biopharmaceuticals and Biosimilars

• Definition and scope of biologics and biosimilars
• Growth of the biopharmaceutical market
• Benefits and challenges of biosimilars
• Key stakeholders in development and regulation
• International perspectives

Module 2: Biopharmaceutical Development Process

• Discovery and preclinical research
• Bioprocess development and optimization
• Quality by design in biologics
• Manufacturing considerations
• Case studies of biologic development

Module 3: Biosimilar Development Pathways

• Scientific principles of biosimilarity
• Demonstrating comparability to reference products
• Analytical characterization techniques
• Functional assays in biosimilar development
• Challenges in proving similarity

Module 4: Good Manufacturing Practices (GMP) in Biologics

• Role of GMP in biopharmaceuticals
• Facility and equipment requirements
• Documentation and quality systems
• GMP inspections and audits
• Compliance challenges

Module 5: Analytical Techniques for Biopharmaceuticals

• Chromatography and electrophoresis methods
• Mass spectrometry applications
• Protein structure and function analysis
• Bioassays for potency and activity
• Case examples in analytics

Module 6: Clinical Trial Design for Biosimilars

• Phases of clinical development
• Equivalence and non-inferiority trials
• Patient safety and ethics in trials
• Statistical considerations in trial design
• Global clinical trial requirements

Module 7: Regulatory Frameworks for Biopharmaceuticals

• FDA and EMA requirements
• WHO guidelines on biosimilars
• Regional and national regulatory frameworks
• Case studies of regulatory approvals
• Harmonization efforts

Module 8: Regulatory Submissions and Dossiers

• Common Technical Document (CTD) structure
• Electronic submissions and eCTD
• Managing queries from regulators
• Timelines for regulatory reviews
• Best practices in submission preparation

Module 9: Intellectual Property in Biopharmaceuticals

• Patents and exclusivity rights
• Data exclusivity for biologics
• Biosimilar patent challenges
• Legal frameworks and case examples
• Strategies for IP management

Module 10: Pharmacovigilance and Risk Management

• Post-marketing surveillance requirements
• Detecting and reporting adverse events
• Risk-benefit assessment for biologics
• Building pharmacovigilance programs
• International pharmacovigilance standards

Module 11: Immunogenicity Assessment

• Basics of immunogenicity in biologics
• Testing methods and assays
• Clinical implications of immunogenicity
• Managing immune responses
• Case studies in immunogenicity

Module 12: Bioprocessing and Manufacturing Technologies

• Upstream and downstream processing techniques
• Cell line development and optimization
• Bioreactor design and operation
• Purification and formulation strategies
• Innovations in manufacturing

Module 13: Quality Assurance in Biopharmaceuticals

• Ensuring consistency and reproducibility
• In-process quality control
• Regulatory expectations for quality systems
• Audits and compliance monitoring
• Case examples

Module 14: Global Market Access for Biosimilars

• Pricing and reimbursement frameworks
• Market entry challenges for biosimilars
• Role of health technology assessments
• Patient and physician acceptance
• Case studies in market access

Module 15: Case Studies in Biopharmaceutical and Biosimilar Regulation

• Lessons from global approvals
• Failures and lessons learned
• Regional perspectives on biosimilars
• Success stories in emerging markets
• Peer-reviewed case exercises

Module 16: Future of Biopharmaceuticals and Biosimilars

• Advances in biotechnology and biologics
• Personalized medicine and biosimilars
• AI and digital health in biopharma
• Next-generation therapies
• Preparing for future innovations

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.