Course No 17082GDP in Switzerland - Specifics in the Distribution of Medicinal Products
3 September 2019, Bern, Switzerland
Regular Fee: EUR 1.190,--
GDP Association Members: EUR 990,--
(All prices excl. VAT)
Tel.: +49 (0)6221 / 84 44 0 E-Mail: email@example.com
If you have any questions, please contact us:
Dr Ina Bach, Dr. Bach AG
Ursula Eggenberger Stöckli, Bratschi Wiederkehr & Buob AG Lawyers
Dr Johannes Fröhlich, Akroswiss
Dr. Remo Studer, Galexis AG
- 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
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 Establishment Licences (Arzneimittel-Bewilligungsverordnung - AMBV or Ordonnance sur les autorisations dans le domaine des médicaments - OAMéd).
Now, 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.
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.
EU Regulations and their Implementation in Switzerland
Practical Implementation in Switzerland
- 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
- 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
- Requirements and due diligence for the Responsible Person according Art. 9 and 13 of the Ordinance on Establishment Licences
- Storage and distribution: current expectations
- Qualification of suppliers and recipients
- Senior Management
- Responsible Person
Storage and Transport: practical Aspects (interactive sessions)
- Principles of liability
- Who is liable?
- Potential sanctions
- Examples from the real life, case law
- Transport qualification/ validation
- Transport at ambient conditions: expectations and control
- Deviation management
- Cool and cold chain
- Risk Analysis
“Very good course”
Igor Todorcevski, Alkaloidpharm SA
“Very useful presentations! Thank you!”
Dr. Thorsten Dedecke, Fresenius Medical Care (Schweiz) AG