Felix Kesselring
Bratschi Rechtsanwälte
Referent:innen
Dr Ina Bach
Dr. Bach
Dr Johannes Fröhlich
Akroswiss
Dr Matthias Schwebe
Roche Pharma
Zielsetzung
- Learn and discuss how to manage your distribution activities GDP-compliant.
- Exchange opinions and convey possible solutions to problems addressed in case studies.
- Benefit from the speakers’ experience in industry, authority and legal advice.
Since 1 July 2015, the EU GDP guidelines do also apply for Switzerland (final implementation on January 1st 2016). This was realised through an adaptation of Annex 2 of Ordinance on EstablishmentLicences(Arzneimittel-Bewilligungsverordnung - AMBV or Ordonnance sur les autorisations dans le domaine des médicaments - OAMéd).
On 1 January 2019, the revised Therapeutic Products Act (HMG 2) and the majority of the revised implementing ordinances
(Therapeutic Products Ordinance Package IV) came into force - with some interesting changes.
On 1 January 2019, the revised Therapeutic Products Act (HMG 2) and the majority of the revised implementing ordinances
(Therapeutic Products Ordinance Package IV) came into force - with some interesting changes.
Holders of an operating license for wholesale activities are obliged to designate a Responsible Person (“Fachtechnisch Verantwortliche Person, FvP)”.
The requirements for a Responsible Person are described in the Ordinance on Establishment Licences.
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, 09 September 2025, 9.00 h – 17.30 h
(Registration and coffee 8.30 h – 9.00 h)
Venue
Essential by Dorint Basel City
Schönaustrasse 10
4058 Basel, Switzerland
Phone + 41 61 695 70 00
Email info.basel@dorint.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
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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