GDP Conference - GDP and the real World

GDP Conference - GDP and the real World

Barcelona, Spain

Course No 16207


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Kane Edgeworth, Biomap
Dr Martin Egger, Pharmaserv Logistics
Michael Fleischer, World Courier
Dr Christian Grote-Westrick, B. Braun Avitum AG
Dr Afshin Hosseiny, European GDP Association
Saddam Huq, GlaxoSmithKline
Johanna Linnolahti, Finnish Medicines Agency Fimea
Federico Lupp, DHL Global Forwarding
Aidan Madden, FivePharma, Ireland
Dr Zvonimir Majic, Teva Pharmaceutical Industries Ltd
Sue Mann, Sue Mann Consultancy
Dr Laura Ribeiro, OCP Portugal
Emil Schwan, Swedish Medical Products Agency
Dr Rob Sleat, Minton Treharne & Davies Ltd (MTD)

Objectives

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.

Background

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.

Target Group

All personnel involved in pharmaceutical storage, transportation, cold chain and distribution activities and the control of those activities.

Free copy of the GDP Guidance on interpretation and implementation

Every participant will get a free copy of the GDP Guidance on interpretation and implementation, a joint publication of the ECA Foundation and the
Pharmaceutical Quality Group of the Chartered Quality Institute.

Programme

Key Note: The X-Factor
Human Behaviours and Errors and what the Responsible Person needs to know about these

Import/Export Activities and their Link to GDP
Import/export activities and their link to GDP (and what an inspector would expect
regarding the GDP quality oversight)

Data Integrity in the Supply Chain
The flow of data and how to control it
Data Governance- what’s it all about?
The paper – IT interface
How to reduce risks
How to handle data and document from partners in the supply chain

Lean GDP – a risk-based Approach for Compliance
How lean is lean?
Efficiency without compromising Quality
How do we deal with guidelines that allow alternative approaches?
Risk management and other tools

Qualification in Transportation of Medicinal Products
Regulatory background
Main drivers for qualifications in transportation of medicinal products
From API to medicinal samples for HCPs
Qualification subject and applicable methodology for each transport mode
In-house and outsourced activities interactions with highlights on 3PL and 4PL roles
and responsibilities

Three parallel Workshops:

1) Supply Chain Mapping and Qualification

  • End to End Supply Chain – where does it start and where does it end?
  • How to map the supply chain process and who are involved?
  • Control and Qualification Process of Supply Chain
2) The GMP/GDP Interface
  • Where does responsibility of the manufacturer end and when does it come back?
  • QP and RP co-operation
  • Deviations in the supply chain: reporting and handling
3) How to perform a GAP Analysis
  • Pre-requisites for an effective GDP implementation
You will be able to attend TWO of these workshops. Please choose the ones you like to attend when you register.

Case Studies
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.

GxP in multi-centre Clinical Trial Logistics
Challenges and solutions

Two parallel Workshops:

1) Distribution of marketed Products: The 2D data matrix code implementation and
what it means for distributers

  • The Delegated Act for the Safety Features: the impact for the different parties in the supply chain
  • Challenges and possible solutions
2) Distribution of Investigational Medicinal Products (IMPs)
  • Challenges when dealing with IMPs
  • What information is needed to help service providers
  • Examples
You will be able to attend ONE of these workshops. Please choose the ones you like to attend when you register.

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 area of the GDP Association’s website http://www.good-distribution-practice-group.org.

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