Supervision of the Pharmaceutical Supply Chain: Challenges and Opportunities
29./30. Juni 2027
Course No. 22910
Speakers
Dr Jens-Uwe Rengers
vorm. Akorn
Dr Rainer Gnibl
GMP Inspector
Cheryl Chia
Lotus Phoenix Consulting
Alexandra Bauloye
Johnson & Johnson Innovative Medicine
Savvas Koulouridas
Fagron BV
Target Group
QPs, RPs, Managers and Executives from pharmaceutical Quality and Supply Chain Units
Senior Management, Business Executives and those involved in improving and controlling the pharmaceutical supply chain
Objectives
Discuss the latest expectations and best practices for effective and efficient Supply Chain Oversight processes and how to get there.
Background 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.
Programme
Highlights
Regulatory and legal Background
Control and Oversight
Import/ Export
Contracts
Necessary GMP-Systems
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
Risk Management Framework to control quality, supply and business risks
Risk Governance model
Risk Register
A view on Drug shortages: requirements and mitigation
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?
Further Information
Technical Requirements Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT) ECA Members EUR 1,890 QP Association Members EUR 1,890 APIC Members EUR 1,990 Non-ECA Members EUR 2,090 EU GMP Inspectorates EUR 1,045 The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference Language The official conference language will be English.
Participant Feedback from previous Courses: „Overall the whole course was a very interesting topic and provided a lot of valuable information on Q-Oversight and I would always recommend this course to others - to colleagues interested in Q-Oversight.”, Stefan Trentmann, DAIICHI SANKYO Europe GmbH, Germany
Date & Time
Tue, 29 June 2027, 09:00–17:00 h
Wed, 30 June 2027, 09:00–14:45 h All times mentioned are CEST.
Costs
Reguläre Teilnahmegebühr*:
€ 2090,-
ECA-Member Rabatt*:
€ 1890,-
Teilnahmegebühr für Mitarbeiter/innen von GMP-Überwachungsbehörden*:
Testimonials
