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Compreendi
Reunião Anual do Colégio de Indústria 2024
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.



Programa

Friday | October 11th

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
15:45 Investing in the Pharma Industry – Is there a roadmap for success?
Glenn Luís, General Director | Fresenius Kabi
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

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

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

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


Sunday | October 13th


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
*To be confirmed

Documentos