Amy Shortman, our Chief Executive Officer, spoke at the Clinical Trials Logistics Conference in May. Here she describes how the conference went, and the benefit of attending such a conference for both ASC Associates and other companies working in this sector.
On a rainy day in Kensington, London, SMI held its 10th Clinical Trials Logistics Conference. It was chaired by Rebecca Jackson, the IVR/IWR Manager for Randomisation & Trials Supply Services at Janssen. Jackson delivered an enigmatic and thought provoking opening presentation explaining how personal experiences of loved one suffering with disease fuelled her passions for research and development of new products.
The day’s agenda was broad, ranging from presentations on Temperature Excursion Management to RTSM or AI; Human versus Machine? However many of the speakers continued the theme set by Jackson’s opening presentation, explaining how their passion for this industry has been sparked by the genuine desire to improve patients’ lives, as one day it could be our family or friend in need of a treatment.
I spoke on ‘Understanding the Impact of the EU GDP Guidelines’. My focus was to explore the impact the MHRA Guidelines for the Short-term Storage of Ambient and Refrigerated products – requirements for a Wholesale Dealers Authorisation (WDA) – had on key stakeholders such as the shipper, 3PL and airline. I presented three case studies using Mundipharma as my shipper, Nippon Express Ltd a 3PL and Virgin Atlantic Cargo, airline.
The results were interesting, as the shippers welcome the changes, which result in its supply chain partners being self-regulated and approved via the licence directly from the MHRA. Although this will never replace due diligence or auditing, it will reduce the level of detail to which the shipper has historically had to audit. For the 3PL and airline, who have been moving pharmaceutical and cool-chain products for years, the WDA will bring formalisation of their processes and proof to their customers of their high quality standards. My message was to embrace these changes as they benefit products and their efficacy, because at the end of the day having medicines that are safe and effective is paramount.
My highlight of the conference was the presentation Terry Madigan, GDP Inspector for MHRA gave. He reaffirmed the MHRA’s stance on the WDA and confirmed that those who are storing refrigerated medicines for human use for any length of time, and CRT (Control Room Temperature or Ambient) for longer than 36hrs, require a WDA. This includes all Logistics providers, Ground Handling Agents and Airlines.
There is still a lot of work to do in the industry, as it is clear from some conversations that there is still uncertainty that the WDA is required by some companies. Maybe it’s denial, but the reality is that compliance is strategically important for any company wishing to work in the distribution of Medicinal Products for human use. Acting sooner rather than later can only be of benefit to your company.
If you are unsure of how this affects your company and would like some training, please contact us.