GDP in Switzerland (GDP 3) - Specifics in the Distribution of Medicinal Products Online Training Recording
Course No. 18517A
Speakers
Felix Kesselring
Bratschi Rechtsanwälte
Dr Ina Bach
Dr. Bach
Dr Johannes Fröhlich
Akroswiss
Dr Remo Studer
Galexis
Objectives
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.
Background
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 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.
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.
Target Group
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 Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
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
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 and Export
Requirements for specific products
Qualification of suppliers and recipients
Senior Management
Responsible Person
Liability
Principles of liability
Who is liable?
Potential sanctions
Examples from the real life, case law
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
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
Recording from 09/10 September 2021 Duration of the recording: approx. 5.5 h
Testimonials