Felix Kesselring
Bratschi Rechtsanwälte
Referent:innen
Dr Ina Bach
Dr. Bach
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 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.
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.
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 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.
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.
Programm
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
Duration of the recording: approx. 5.5 h
| Regular Fee*: | € 1190,- |
| EU/GMP Inspectorates*: | € 595,- |
| GDP Association Member Discount*: | € 990,- |
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
Dieses Seminar ist Bestandteil des GMP-Lehrgangs "Verantwortliche Person für GDP/Großhandelsbeauftragte/r (GDP)"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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