Cheryl Chia
Lotus Phoenix Consulting
Referent:innen
Dr Torsten Schmidt-Bader
moveproTEC Compliance & Innovation Advisory
Emil Schwan
Swedish Medical Products Agency
Zielsetzung
The aim of this conference is to inform about recent experiences made in the implementation of the EU GDP Guidelines. Challenges and possible solutions will be discussed and examples will demonstrate how the requirements can be put into practice.
Hintergrund
It is of key importance that medicinal products are not only made to a high quality in accordance with Good Manufacturing Practice (GMP), but that the quality and integrity of these products are maintained through the entire supply chain to the patient. This is where Good Distribution Practice (GDP) comes into Play.
In the last few years the world of GDP has changed in scope and complexity and continues to evolve to meet new challenges with the continued aim of safeguarding public health. The Falsified Medicines Directive (2011/62/EU) was transposed into the laws and regulations of the EU Member States alongside the introduction of revised EU guidelines on Good Distribution Practice. Many other countries followed adopting these Guidelines or implementing very similar approaches.
In the last few years the world of GDP has changed in scope and complexity and continues to evolve to meet new challenges with the continued aim of safeguarding public health. The Falsified Medicines Directive (2011/62/EU) was transposed into the laws and regulations of the EU Member States alongside the introduction of revised EU guidelines on Good Distribution Practice. Many other countries followed adopting these Guidelines or implementing very similar approaches.
Zielgruppe
All personnel involved in pharmaceutical storage, transportation, cold chain and distribution activities and the control of those activities.
Question and Answers Session
You will be able to send in GDP related questions before the conference. Additionally, questions can be posted on question cards during the conference.
Answers will be given by the expert speakers in a dedicated session and published in the members are of the GDP Association’s website (www.good-distribution-practice-group.org).
Answers will be given by the expert speakers in a dedicated session and published in the members are of the GDP Association’s website (www.good-distribution-practice-group.org).
Programm
Performance beyond Compliance
- Benchmarks with sense
- When is a system or process robust?
- Easily understandable key figures
- Case studies
Brexit Implications
- Import/ export issues
- Drug shortage challenges
- Falsification
- Serialisation
- Co-operation of the agencies
GDP Challenges in Africa
- Background
- Evolution of GDP over the years
- Problems involved
- Steps taken to improve
Customer Master Data
- Definitions
- Parties involved
- Responsibilities and RP oversight
- Managing Customer Master Data
- Lifecycle Management
3 parallel Workshops:
1. Risk Management in GDP Warehousing
- Challenges and possible solutions
- Examples
2. When things go wrong – what can happen in the real World
- Experiences made in examining problems in the supply chain – and what to learn from them.
3. How to deal with suspected and confirmed falsified Medicines
- What is a suspected falsified medicine
- How to identify falsified medicine in your workplace
- How to approach the investigation of a suspected pack
- What should the end user do with the pack – who should manage communication with the end users
You will be able to attend TWO of these workshops. Please choose the ones you like to attend when you register.
Case Studies:
The Roche Quality Governance Model for Distribution to Direct Markets
- Selection, implementation, operation and decommissioning of partners
- Key Performance Indicators (KPIs)
- Compliance score card
The Switch from Air-freight to Sea-Freight
- Challenges and Benefits
- Examples
From external to internal Solutions - Insourcing of Warehousing and Logistics
- Implementation of own storage areas for minimum supply at the site
- Container and transport vehicle purchasing (refrigerated, warm, hazardous)
2 parallel Workshops:
1. Master Data and Serialisation
- Master Data for Serialisation
- Alerts Handling
- Exercises
2. Distribution of ATMPs
- Challenges when dealing with ATMP
- What information is needed to help service providers
- Examples
You will be able to attend ONE of these workshops. Please choose the one you like to attend when you register.
| ECA-Member*: | € 1590,- |
| Non ECA Member*: | € 1790,- |
| EU/GMP Inspectorates*: | € 895,- |
| APIC Member Discount*: | € 1690,- |
| GDP Association Member Discount*: | € 1590,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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