Dr. Jens-Uwe Rengers
vorm. Akorn
Referent:innen
Dr Rainer Gnibl
GMP Inspector
Cheryl Chia
Lotus Phoenix Consulting
Alexandra Bauloye
GSK
Savvas Koulouridas
Fagron BV
Zielsetzung
This 2-day Master Class brings together well-experienced experts to discuss the latest expectations and best practices for effective and efficient Supply Chain Oversight processes and how to get there.
Hintergrund
There is a steady increase in dependence on global supply chains. Pharmaceutical companies not only source starting materials from all over the world, but also outsource manufacturing activities. The finished products are then distributed globally. These complex supply chains with different transport routes and manufacturing locations lead to major challenges in terms of maintaining the quality of materials, intermediates and medicinal products.
This has increased the risk of potential compliance and delivery problems, having a negative impact on a company’s business and on the patient. Managing these supply chains and complying with GMP and GDP regulations require a comprehensive supply chain oversight with appropriate risk management measures.
The manufacturer, the Qualified Person (QP) but also the Responsible Person (RP) are primarily responsible for compliance with EU/EEA requirements:
This has increased the risk of potential compliance and delivery problems, having a negative impact on a company’s business and on the patient. Managing these supply chains and complying with GMP and GDP regulations require a comprehensive supply chain oversight with appropriate risk management measures.
The manufacturer, the Qualified Person (QP) but also the Responsible Person (RP) are primarily responsible for compliance with EU/EEA requirements:
- EU-GMP Annex 16, General principles: “The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH).”
- EU-GMP Annex 16, 1.7.2: “The entire supply chain of the active substance and medicinal product up to the stage of certification is documented and available for the QP. This should include the manufacturing sites of the starting materials and packaging materials for the medicinal product and any other materials deemed critical through a risk assessment of the manufacturing process. The document should preferably be in the format of a comprehensive diagram…”
In the meantime, the competent authorities and inspectorates are also focusing on supply chain oversight processes; manufacturers and especially the marketing authorisation holder must know and control every level of the supply chain.
Zielgruppe
QPs, RPs, Managers and Executives from pharmaceutical Quality and Supply Chain Units but also Senior Management, Business Executives and those involved in improving and controlling the pharmaceutical supply chain.
Date & Venue
Date
Thursday, 26 June 2025, 9.00h – 17.00h
(Registration and coffee 8.30h – 9.00h)
Friday, 27 June 2025, 8.30h – 15.00h
Thursday, 26 June 2025, 9.00h – 17.00h
(Registration and coffee 8.30h – 9.00h)
Friday, 27 June 2025, 8.30h – 15.00h
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona, Spain
Phone: +34 / 93 / 503 53 00
Email: sants@barcelo.com
Programm
Gesamtes Programm als PDF herunterladen
Supply Chain Security: Regulatory Background
- Globalization: Challenge & risk also besides GMP/GDP
- Legal „oversight“ requirements
- Responsibilities
- GMP-/GDP interface
- What do inspectors expect?
- Which are the essential tools?
Other legal Aspects to consider
- The EU Supply Chain Act and its consequences for pharmaceutical companies (Corporate Sustainability Due Diligence Directive (CSDDD)
- EMA recommendations to strengthen supply chains of critical medicinal products and other necessary actions to avoid drug shortages (MSSG, CMA)
- Strategies to avoid drug shortages
Supplier Control
- How to keep oversight over the pool of suppliers and brokers
- Ongoing Supplier Qualification
- Active Supply Chain tracking
- Filing second source suppliers for APIs
Useful Supply Chain Diagrams
- Initiation and creation
- Management and change control
- Examples
Master Data in the Supply Chain
- The broader framework on Master Data
- How will this impact the pharmaceutical supply chain?
- What does this mean for supply chain organisations?
- What does this mean for the quality organisations supporting the supply chain?
- Become a master of your data!
Import and Export: Regulatory Perspective in EU
- Annex 16: Supply chain Focus
- Annex 21: Consequences
- Inspector´s considerations on “best practices”
Contract Handling
- Different contracts in the Supply Chain (Forecasting, Supply, Quality/ Technical Agreement …)
- Who needs to sign
- Contract handling: how to keep them up to date, how to avoid contradictions
Risk Management in the Supply Chain
- How to control quality, supply and business risks
- Drug shortages: requirements and Mitigation
- Risk Register
Shipping Lane Risk Assessments
- Do we need them?
- What aspects of the shipping lane should be included?
- How much detail should be included?
- What actions might come out of the shipping lane assessment?
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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