RACI Beyond Borders: Key pharma enablers to Global Competition
The role of the Qualified Person (QP) emerges as a crucial enabler in the current pharmaceutical industry global competition landscape. Key to this environment are intellectual property rights, alongside a conducive ecosystem for R&D and efficient manufacturing operations, while regulatory harmonization plays a significant role, streamlining market access and minimizing costs. QP’s skills are reinforced as a safeguard to continue ensuring compliance with international standards, enhancing product trust, quality, efficacy and safety. Advanced digital technologies, such as AI and blockchain, are already pivotal in research, as an example, with QPs overseeing their potential integration in quality assurance processes.
RACI 2024 will be an exciting opportunity to meet and debate the competitiveness response to local and global market demands, relying on QPs to maintain product integrity and regulatory alignment, ensuring that pharmaceutical companies can innovate, compete and effectively meet the healthcare needs of the populations worldwide.
The role of the Qualified Person (QP) emerges as a crucial enabler in the current pharmaceutical industry global competition landscape. Key to this environment are intellectual property rights, alongside a conducive ecosystem for R&D and efficient manufacturing operations, while regulatory harmonization plays a significant role, streamlining market access and minimizing costs. QP’s skills are reinforced as a safeguard to continue ensuring compliance with international standards, enhancing product trust, quality, efficacy and safety. Advanced digital technologies, such as AI and blockchain, are already pivotal in research, as an example, with QPs overseeing their potential integration in quality assurance processes.
RACI 2024 will be an exciting opportunity to meet and debate the competitiveness response to local and global market demands, relying on QPs to maintain product integrity and regulatory alignment, ensuring that pharmaceutical companies can innovate, compete and effectively meet the healthcare needs of the populations worldwide.
Programa
Friday | October 11th
Saturday | October 12th
Sunday | October 13th
*To be confirmed
12:30 | Lunch |
14:15 | Opening Session Paula Teixeira, President of the Board of Pharmaceutical Industry Specialists (CCEIF-OF) Paula Costa, Portuguese Pharmaceutical Society (OF) |
|
PANEL I : Staying Ahead: Ensuring Industry Competitiveness
Chair: António Bica, Member of CCEIF-OF |
|
14:45 |
The competitiveness of the Portuguese based Pharma Industry – The Regulator’s View Rui Santos Ivo, President of the Board of Directors | Infarmed |
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15:45 | Investing in the Pharma Industry – Is there a roadmap for success? Glenn Luís, General Director | Fresenius Kabi |
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16:30 | Q&A |
17:00 | Networking Break |
17:30 | Beyond batch release – The QP as a business partner Manuel João Oliveira, General Manager | Iberfar |
18:15 | Q&A and Closing Remarks |
Saturday | October 12th
|
PANEL II : Intelligent Automation in Pharma Industry
Chair: Teresa Murta, Member of CCEIF-OF |
09:00 | AI-based computer vision systems for Pharma Manufacturing Júlio Fonseca | Primanota |
09:30 | Navigating the Digital Transformation: A Pharma 4.0 Road-map Russel Coelho | Vimachem |
10:00 | Challenging Digitalization & Enhancing Capabilities within the Regulatory Framework Jessica Navarro, Strategy Director | Veeva |
10:30 | Q&A |
10:45 | Networking Break |
PANEL III : Profiling the next QP generation
Chair: Paula Teixeira, President of the Board of Pharmaceutical Industry Specialists (CCEIF-OF) |
11:30 | My path as a Qualified Person – Learning, Leadership, and Legacy Gabriela Lourenço, Head of Quality Unit | QP Sidefarma |
12:00 | The QP in a Digital Environment – Challenges, Opportunities and Harmonization José Machado, Quality Control Director | QP Bial |
12:30 | Q&A |
12:45 | Lunch |
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PANEL IV : At the Heart of Quality Management
Chair: Bruno Morgado, Member of CCEIF-OF |
14:15 | Introduction of new products – The role of QM in Tech-Transfer Hugo Almeida |
14:45 |
Ensuring Inspection Readiness: Comprehensive strategies and best practices for sustained compliance. André Luz, Managing Director | OWLPHARMA |
15:15 | Q&A |
15:30 | Networking Break |
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PANEL V : Innovative GMP Challenges Chair: João Lopes, Member of CCEIF-OF |
16:15 |
Batch certification for new manufacturing technologies: From raw materials to advanced finished products Miguel Fagundes, Industrial Director | TechnoPhage |
16:45 | The landscape of continuous manufacturing Burkhard Schmidt, Agrosistema | L.B.Bohl |
17:15 | Q&A |
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Speakers Corner Chair: Margarida Henriques, Member of CCEIF-OF |
17:30 | Efficient Changeover Through SMED and OEE Ana Rita Bernardino |
18:00 | Q&A and Closing Remarks |
PANEL VI : Our commitment with Ethical and social responsibilities
Chair: Elvira Raposo e Margarida Henriques, Members of CCEIF-OF |
10:00 | Take action, create impact, go sustainable Luís Figueiredo, General Director | Valormed |
10:45 | ESG - Beyond legal obligations Paula Martins, EHS&S Manager | Recipharm Lisboa |
11:30 | Q&A |
11:45 | Best Poster Award and |
12:00 | Closing Session Paula Teixeira, President of CCEIF-OF Helder Mota Filipe, President of the Portuguese Pharmaceutical Society (OF) |
13:00 | Lunch |
Documentos
- The landscape of continuous manufacturing Burkhard Schmidt | Agrosistema, L.B.Bohle
- Introduction of new products – The role of QM in Tech-Transfer Hugo Almeida | CEO, CoLAB AccelBio
- The QP in a Digital Environment – Challenges, Opportunities and Harmonization José Machado | Quality Control Director, QP Bial
- My path as a Qualified Person – Learning, Leadership, and Legacy Gabriela Lourenço | Head of Quality Unit, QP Sidefarma
- Batch certification for new manufacturing technologies: from raw materials to advanced finished products Miguel Fagundes | Industrial Director, TechnoPhage
- The competitiveness of the Portuguese based Pharma Industry – The Regulator’s View Rui Santos Ivo | President of the Board of Directors Infarmed