23-24 April 2024
Coventry Building Society Arena
GDP Theatre Seminars
Good Distribution Practice – An Update on the Universal Compliance Initiative
- Alan Kennedy Executive Director - GDP-Universal Compliance Initiative
How Are We Going to Balance Medicines Distribution With NHS Net Zero Targets?
- Martin Sawer Executive Director - HDA UK
Risk-Based Approaches in Auditing
- Phil Butson PQG
GDP – The QMS and Data Integrity
- Neil Wayman Secretary - PQG
Volatile Supply Chains: A QO & RPI’s Perspective
- Mukesh Patel Founder and Director - CommQP Ltd
The Pharma Supply Chain & Risk Management
Presentation on the supply chain giving a visual demonstration and talk of each of the points. Each point will highlight the risks involved and possible mitigations. We will include elements of temperature management packaging and how this can aid successful distribution, as well as the different carrier options available.
20 minutes will be spent interacting with the audience. We will show an FMEA model example of a pharmaceutical export route and ask members of the audience to volunteer the risk identificationa and scores and how this can be mitigated. This will then conclude in a completed lane validation and the audience will have an understanding of how to complete.
Temperature Management in the End-to-End Supply Chain
- Chris Martin Director & RP - Christa GDP Pharma Ltd
Managing the Change: From In-House Warehousing to a Third-Party Logistics (3PL)
In this presentation, I will aim to explore the challenges and benefits associated with using a 3PL provider and choosing the right one. I then will explore the journey of the change from in-house warehousing to a 3PL. My discussion will span various considerations, from selecting the appropriate 3PL to the preparation and actual transition process, along with the impact on GDP in these areas. Drawing from practical observations, both the advantages and challenges will be discussed.
- Migle Mikalajunaite Quality Contoller, RP and RPi - Syner-Med Pharmaceutical Products Ltd
The Supply of Medicines Across the UK – The Impact of the Windsor Framework
The Government of the United Kingdom (UK) introduced temporary measures to address problems with the supply of medicines to Northern Ireland in the wake of the UK’s withdrawal from the European Union (EU); both the UK and EU recognised that there were difficulties in operating the “Protocol on Ireland and Northern Ireland”, an agreement intended to protect the terms of the 1998 “Belfast Agreement” and preserve the close relationship between the Republic of Ireland and Northern Ireland.
These temporary measures (such as the Northern Ireland MHRA Authorised Route, “NIMAR”) were considered necessary by the UK, as the implementation of the Protocol on Ireland and Northern Ireland had created supply chain issues which impacted on public health in the region.
Despite these temporary measures, there was evidence that supply problems persisted – this was seen not only for medicines, but other areas of trade between Great Britain and Northern Ireland as well.
On 27 February 2023, the UK and EU published the “Windsor Political Declaration by the European Commission and the Government of the United Kingdom”, which is also known as the “Windsor Framework”. This framework, which was adopted by the EU-UK Joint Committee in March 2023, applies to trade between Great Britain and Northern Ireland whilst aiming to protect the EU market. This presentation will summarise the framework and MHRA expectations for the licensing & supply of medicines across the UK going forward.