GDP Theatre 2 Seminars

Virtual wholesaling and traditional wholesaling differ in terms of operational efficiency and accessibility. In traditional wholesaling, the RP (Responsible Person) has full oversight of physical inventory and oversees distribution activities directly from warehouses or supply centres.

In virtual wholesaling, the distribution activities are undertaken remotely, and the operations rely heavily on 3rd party suppliers to physically hold and move their products. Virtual wholesaling offers flexibility, a broader market reach and less overhead, however, the RP must still ensure compliance with pharmaceutical regulations and reliable logistics partners to maintain product integrity through a secure supply chain.

How does a virtual RP maintain the right level of oversight in these different business models?

This presentation will provide an overview of the challenges in the virtual wholesaling and how to plan for a successful launch of product within the market.
To enter the market, companies need not just an Approved Marketing Authorisation but also a licensed supply chain, including authorisations for importation, batch release, and distribution.
This session will focus on the distribution aspect of a market launch by a virtual wholesaler with a review of the challenges :
- Planning the Wholesale Distribution strategy
- Setting up a Virtual Wholesale Operation
- Sourcing product and Launch challenges
- Challenges of managing supply chain integrity and patient safety
- Outsourced Activities

An explanation of the ways criminals commonly attempt to infiltrate the supply chain. For example, through domain impersonation, WDA hijacking, supplying medicines which have knowingly been stored incorrectly/stolen, supplying products which are completely falsified and not manufactured to proper (or any!) standards.
Despite being one of the most important responsibilities, not all attempts can be publicised at the time of occurrence as it can jeopardise ongoing investigations/prosecutions. This presentation will have anonymised, real-life scenarios of concluded investigations, to show that it is not just a theoretical threat.

A presentation in general about what happens when companies fail to maintain quality, the risks to patients, the catastrophic risk to the companies (in many cases they have closed) and how you can protect yourself, patients and respond if things do go bad.

Intending to include a section on the MHRA Inspection Action Group, and how to best deal with any critical deficiency.

With global freight increasing and supply chain disruptions on the rise, the pressure on cold chain transportation has never been higher. Managing temperature-sensitive logistics can seem overwhelming, as a single misstep can result in product loss and financial disaster. However, with expert guidance, you can successfully navigate these challenges. John Coleman, Business Unit Director for YSDS Life Science, brings 20 years of experience in cold chain logistics, quality assurance, and risk assessment. In this 45-minute session, he’ll guide you through the cold chain process, teaching you how to create validated logistics solutions, avoid delays, reduce temperature deviations, and mitigate risks.

The presentation will discuss the thermal modelling/simulation tools that are currently available and used to support analysis and testing within pharmaceutical temperature-controlled supply-chain. What considerations must be considered for model characterisation and accuracy. How thermal modelling/simulation is currently used and what could be potential uses in the future. Finally, a review of the benefits of using simulation within your supply-chain operations.

Radiopharmaceuticals play a crucial role in diagnosing and treating diseases like cancer. Given their short half-life, transporting these materials involves complex logistical challenges that demand swift delivery, rigorous safety protocols, and flawless execution. In his presentation, Peter Smith, Senior Vice President Life Couriers UK, will emphasize the importance of precise labelling, thorough documentation, and trained personnel. He will also showcase flexible contingency planning and share real-life examples from Life Couriers to illustrate how critical deliveries are safely and reliably completed.

Brexit has had significant impact on the pharmaceutical industry, with particular impact on the supply chain covering both import and export.
The UK is now considered a third country and the impact of this includes increased inspection for competent health authorities, changes to supply routes, changes to medicines offered in specific markets and changes to process (for example, EU QP release and testing, and RPi).
The Windsor Framework focuses specifically on the continued supply into Northern Ireland and Republic of Ireland, and there has been significant impact to the supply chain including longer lead times, reduced range and increased process (to increase even further from January 2025).
A requirement for the greater focus on supply chain mapping.