Dr Ina Bach
Dr. Bach
Referent:innen
Dr Johannes Fröhlich
Akroswiss
Felix Kesselring
Bratschi Rechtsanwälte
Dr Remo Studer
Galexis
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.
Hintergrund
Quality requirements for medicines do not end after production and packaging. Medicines and APIs are often shipped over long distances and different climate zones and stored in various warehouses. Once the WHO has taken the lead with its guidelines „Good Storage Practices for Pharmaceuticals“ (2003) and „Good Distribution Practices for Pharmaceutical Products“ (2010), more and more compliance with good storage, transportation and distribution practice was emphasised worldwide. Another milestone were the EU-GDP guidelines from 2013 with a lot of intensified demands.
For quite a while it was rather unclear how these guidelines are applicable in the non-EU country Switzerland. Under the Agreement of 21 June 1999 between the Swiss Confederation and the European Community (Mutual Recognition Agreement, MRA), Switzerland obliged to comply with the EU-GMP regulation. However GDP was not covered.
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 Establ ishmentLicences(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. Various transitional provisions for licenses issued under the old legislation are defined. However, for all new/renewed applications, the new legislation will apply in its entirety.
Zielgruppe
This Live Online Training 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.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
09.00 – 09.10 h
Introduction
Introduction
09.10 – 10.00 h
Legal Bases for the Distribution of Medicinal Products
- Legal basis in Switzerland including EU regulations
- The Ordinance on Establishment Licences OEL (AMBV, OAMéd)
- The revised Therapeutic Products Act (HMG 2): relevant changes
- GMP/GDP Interface
- Working with contractors
10.00 – 10.20 h
Break
Break
10.20 – 11.40 h
Tasks and Responsibilities
- Requirements and due diligence for the Responsible Person according Art. 9 and 13 of the Ordinance on Establishment Licences
- Storage and distribution: current expectations
- Cross-border Distribution: Requirements for Import andExport
- Requirements for specific products
- Qualification of suppliers and recipients
- Senior Management
- Responsible Person
11.40 – 12.30 h
Liability
Liability
- Principles of liability
- Who is liable?
- Potential sanctions
- Examples from the real life, case law
12.30 – 13.30 h
Break
13.30 – 15.30 h
Storage and Transport: Practical Aspects
a) Warehouse
- 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
15.30 – 15.50 h
Break
Break
15.50 – 17.15 h
Practical Implementation in Switzerland
- The GDP Inspection: what do inspectorates expect and how to prepare
- Wholesaler vs. Pre-Wholesaler: interfaces and delimitation
- Transport at storage conditions: best practices
- Case Study: transport validation
17.15 – 17.30 h
Final Discussion
Final Discussion
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