Programação

CURSO INTERNACIONAL FIOCRUZ-REDE PASTEUR
BIOPRODUÇÃO, PROPRIEDADE INTELECTUAL E TRANSFERÊNCIA DE TECNOLOGIA
De 08 a 12 abril de 2024

 
Monday , 08 th April
 
Time (Local) Activity/Event Lecturer  
8h30-9h Opening remarks
  • Pasteur Network
  • Fiocruz
  • French Embassy (Scientific attaché)
    
Bio- Production/Block 1. Immunology of biologicals and preclinical research
Basic concepts of immunology, immune response to vaccines and biopharmaceuticals and how to translate this into product development and licensing.
9h- 9h20
  • Portfolio of R&D and Production of Immunobiologicals in Bio-Manguinhos;
 Lecturers:  
9h20-09h50
  • Vaccinology: Past, Present and Future;
 Lecturers:  
9h50 -10h10 Coffee Break
10h10 -10h40
  • Policy and regulation of biologics in Brazil and in the World
 Lecturers:  
10h40 -11h10
  • New vaccine production platforms (mRNA and viral vectors);
 Lecturers:  
11h10 -11h40
  • Technological platforms for production;
 Lecturers:  
11h40 -  12h10
  • Drug discovery and preclinical and Non-Cinical.
 Lecturers:  
12h10 -12h30 Discussion and Questions
12h30-14h Lunch
Bio- Production/Block 2. Development and Production of Biologicals
Understand the processes and requirements needed in the R&D, Technological Development and Production chain.
14h – 14h30
  • Drug development process, from the bench to the market and the product life cycle;
    
14h30 – 15h
  • Quality System: Quality Assurance and Control;
    
15h- 15h20 Pause
15h20 – 15h50
  • Good practices (GxP) applied to the development and production of biologics;
 Lecturers:  
15h50 – 15h50 
  • Requirements and structure of manufacturing facilities, clean areas, containment for production;
 Lecturers:  
15h50– 16h20
  • Development of Bioprocesses;
    
16h20 -16h30 Discussion and Questions
Tuesday 09 th April
09h– 09h30
  • Scheduling, Development, and Validation of Process Control Methodologies
 Lecturer:  
09h30 -10h
  • Development and validation of analytical quality control methodologies;
 Lecturer:  
10h – 10h20 Coffee Break
10h20 – 10h50
  • Development of formulations and stability studies;
 Lecturer:  
10h50 -11h20
  • Production of clinical batches in GMP.
 Lecturer:  
11h20 – 11h50 Discussion and Questions
11h50 -13h20 Lunch
Bio- Production/Block 3. Clinical Trials and Product Registration
Understand the requirements and quality assurance in the execution of clinical trials and the operational requirements for the planning and execution of clinical trials of biologics (ethical considerations, site feasibility, aspects of recruitment, monitoring, and quality assurance).
13h20 -13h50
  • Design, clinical trial, and study dossier for authorization by the Health Surveillance Agency;
 Lecturer:  
13h50 – 14h20
  • Regulatory aspects for biological products;
 Lecturer:  
14h20 – 14h50
  • Pharmacovilance;
 Lecturer:  
14h50 -15h20
  • Product registration and post-Marketing.
 Lecturer:  
15h20 -15h40 Pause
15h40 – 16h10 Discussion and Question
Wednesday, 10 th April
Bio- Production/Block4. Public Health and Immunization Policy Development- An overview of immunization and public health around the world. Deepening students' understanding of the general principles of the pharmaceutical development process, with the ultimate goal of ensuring the sustainability of life-saving vaccination programs globally.
09h – 09h30
  • Immunization and public policies for a vaccination program;
 Lecturer:
 		  
09h30 – 10h
  • Organization, operation, and search for high vaccination coverage.
 Lecturer:
 		  
10h – 10h20 Discussion and Question
10h20- 10h40 Coffee Break
Intellectual Property – Basic Concepts
10h40 -11h30
 		 Main International Treaties Lecturer:
 		  
11h30-12h30 Patents Lecturer:  
12h30-14h Lunch
14h-15h Trademarks, Copyright and Software Lecturer:  
Technology Transfer – An Overview
15h-16h10
 		 Main Types of Legal Agreements and Practical Applications of Legal Agreements Lecturer:  
16h10-16h30 Discussion and Questions
THURSDAY , 11 th APRIL
Business and Technology Intelligence – Basic Topics
9h-10h Main Sources of Information
Patent Literature Search (Free Databases) and other sources
 Lecturer:  
10h-10h30 Coffee Break
10h30-11h30
 		 Patent Landscape Analysis Lecturer:
 		  
Fiocruz Innovation Ecosystem
11h30-12h30 Fiocruz Innovation Ecosystem
  • Fiocruz's Technological Management Model: “Sistema Gestec-NIT”
  • “Café com Inovação”
  • Fiocruz Innovation Portfolio
 Lecturer:
 		  
12h30-14h Lunch
Strategic management of Fiocruz's patent portfolio
14h-15h The Fiocruz Patent Commission (COPAT) Lecturer:  
15h-15h30 Tips for Success in your Patent Application                    Lecturer:
 		  
Entrepreneurship – An Overview
15h30-16h10 Entrepreneurship at Fiocruz – Practical Cases Lecturer:  
16h10-16h30 Discussion and Question
Friday, 12 th April
9h – 9h30 Final Discussion and coffee
9h30 – 12h Visit to Bio-Manguinhos, production and quality control areas.
12h-13h30 Lunch
13h30– 15h30 Visit to Mourisco Castle