Felix Kesselring
Bratschi Rechtsanwälte
Referent:innen
Dr Ina Bach
Dr. Bach
Dr Johannes Fröhlich
Akroswiss
Dr Matthias Schwebe
Roche Pharma
Zielsetzung
This seminar provides an update on the legal framework, regulatory expectations and practical implementation of GDP in Switzerland.
- Gain a comprehensive understanding of the legal and regulatory framework for the distribution of medicinal products in Switzerland.
- Learn how to implement and maintain a GDP-compliant quality system, including documentation, qualification, and validation of critical distribution steps.
- Discuss the roles, tasks, and liability of the Responsible Person (Fachtechnisch Verantwortliche Person, FvP).
- Exchange experience and best practices with experts from industry, authority, and legal practice.
- Apply regulatory expectations to real-life examples, including transport validation, vehicle qualification, and stability considerations during storage and shipment.
Hintergrund
Quality requirements for medicines do not end after production and packaging. Medicines and APIs are often shipped over long distances and across different climate zones and stored in various warehouses.
Companies are required to demonstrate that all activities related to storage, handling, and transport are conducted under controlled and monitored conditions. The increasing complexity of global supply chains, temperature-sensitive products, and multiple distribution partners make it essential to have a well-established quality system in place. It is expected to ensure that processes are transparent, traceable, and continuously improved.
This course provides a comprehensive overview of key aspects of pharmaceutical distribution in Switzerland and offers practical insights into how GDP requirements can be translated into daily operations.
Zielgruppe
This course has been designed for employees, specialists and managers from storage, transportation and distribution as well as their colleagues from quality control, quality assurance and production, which are involved in the various processes of drug logistics.
Date / Venue / Presentations / Certificate
Date
Tuesday, 08 September 2026, 9.00 - 17.30 h
(Registration and coffee 8.30 - 9.00 h)
Venue
Pullman Basel Europe
Clarastr. 43
4058 Basel, Switzerland
Phone: +41 (0) 61 690 80 80
h5921@accor.com
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Legal Bases for the Distribution of Medicinal Products
- Swiss Law and European Law
- Act on Therapeutic Products
- Ordinance on Establishment Licences
- European Guidelines on Good Distribution Practice of Medicinal Products for Human Use (GDP)
- European GDP Guidelines for Active Substances - Outsourced activities
- Written contract for outsourced activities
Tasks and Responsibilities
- General considerations on GDP in Switzerland
- Legal Basis
- Revision of the Therapeutic Products Act (HMG) and ist effects
- Authorization types
- GDP Requirements
- Quality in the supply chain
- Technically Responsible Person (FvP) - General
- FvP - Delegation
Liability
- Responsibility and liability: Terms
- Different kinds of responsibilities
- Administrative responsibility
- Civil responsibility
- Criminal responsibility - Protection of the Responsible Person
- The Responsible Person in case law
Practical Implementation in Switzerland
- The GDP inspection: preparation and implementation
- Wholesale vs. pre-wholesale: demarcation and similarities
- Transport in accordance with storage conditions: best practices
- Case study: validation of transport routes, qualification of transport vehicles
Storage and Transport: Practical Aspects (Interactive Session)
a) Warehouse
- Requirements
- Qualification
- Mapping
- Hygiene
- Documentation
- Requirements
- Qualification
- Mapping
- Hygiene
- Documentation
b) Transport
- Transport qualification/ validation
- Transport at ambient conditions: expectations and control
- Deviation management
- Cool and cold chain
- Risk Analysis
- Training
- Transport qualification/ validation
- Transport at ambient conditions: expectations and control
- Deviation management
- Cool and cold chain
- Risk Analysis
- Training
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
| GDP Association Member Discount*: | € 1090,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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