My Standout Favourites from PharmaLink 2015

By Dee Carri, Friday, 10th April 2015 | 0 comments
Filed under: SOPs, Quality, Compliance, Operations, Pharma, Pharmaceuticals, Measurement, Metrics.

My Standout Favourites from PharmaLink 2015

Dee Carri

You know how it goes with conferences, everything is interesting when you are at a conference but when you are back in the routine for a couple of weeks you just have a fuzzy memory of the people you met and the topics you engaged with. This was so not the case with the PharmaLink Conference where attendees were highly engaged and open to sharing knowledge and experience, the presenters were expertly putting forward novel and sometimes provocative ideas and topics were relevant and well balanced. For me personally, a big highlight was meeting many of the subject matter experts that I’ve been working with on the PharmaLink Metrics programme for almost a year, so it was lovely to meet them and put a face to a voice that I had only heard at conference calls.

So, you might well ask what, if anything, stands out for me two weeks after the event?

Actually, there were a lot of great presentations and talks and they are all available on the PharmaLink website. The deep dive lunch was a real feature where groups met in a world-café type setting to discuss specific challenging topics and their valuable outputs will feed back into relevant research efforts.

Out of the sessions that I attended, there are a few that continue to resonate that I’d like to share, together with a brief intro on why I found them so interesting.

Same-old, same-old inspection outcomes

This stands out for all the wrong reasons. I felt sorry for the regulatory agency speakers who are beating the same old drum for as long as I’ve been in the industry. It seems that apart from conducting more inspections in foreign (non-US) countries, nothing much has changed over the years in terms of inspection outcomes: poor documentation, non-adherence to SOPs, non-validated computer systems, falsified results, stuff hidden behind production doors etc. Wouldn’t you think that industry would step up and improve?

Supplier Management (Establishing Good Supplier Practices)

When problems occur in the supply chain, we often quick to blame the supplier. Marla Phillips and Dale Carter provided a compelling presentation and talk that forces us to face facts: oftentimes problems are caused by customers. Follow up informal chats with some of the logistics vendors who were at the conference provided some real-life-examples that seemed to indicate that Marla and Dale hit the nail on the head! The great news if you are a customer is that you can improve. To find out how, you can access the presentation here.

Catching the Baddies

When we think of the Pharma industry words like safe, secure and orderly pop into our heads. Whilst this is mostly true, it is not always the case and co-operation between Pharma, the crime agencies and regulatory agencies is critical to fighting this type of crime.

Cheryl Flurer of the FDA Forensic Chemistry Centre provided a fascinating insight into the underbelly of the pharmaceutical industry, explaining what is required in terms of scientific knowledge, level of detail and patience required to make an impact in this problematic area. Personally, I think this presentation and delivery would make a great basis for a public education documentary. You can access the presentation here.

Train your Chain!

Are you an importer of pharmaceutical products to the US? If so you need to read and understand this presentation where Professor Jim O’Reilly explains the requirements of FDASIA and the responsibilities of foreign (non-US) importers under the Act. Briefly, if you want access to the US Market, you must provide earlier documentation to FDA inspectors, you must train your staff on the FDASIA requirements – hence his strap line “train your chain”! Failure to meet the requirements can result in dire consequences for your business and possibly your executives. You can access the presentation here.

Getting the measure of Pharma

Good manners dictate that upfront I declare myself a speaker on Metrics and a facilitator during the metrics deep dive lunch but, that not withstanding, metrics was a main theme of the conference and therefore of enormous interest to me and most of the attendees.

We had presenters from the different industry bodies working on the topic which provided insightful and timely updates on their work.

This topic has many aspects and different industry groups are taking on quite different facets – which are very efficient and good in the overall context of the industry:

  • ISPE is focussed on the possible metrics required by FDA and has conducted a pilot programme with some of its members. They will announce the pilot results in April. You can access Mike Davidson’s presentation here.
  • PDA has conducted a survey of its members on Culture of Quality and continues to work on this topic. You can access Steve Mendivil’s presentation here.
  • Xavier / PWC initiative (the initiative that I am co-leading) has taken a more comprehensive scope that is focussed on providing metrics that will, if used correctly, will provide better outcomes for companies and the entire industry. Under this remit, it is developing pre-production, production, post-production and culture of quality metrics. Xavier also has initiatives in Supply Chain Integrity and Device Manufacturing so these three initiatives complement each other. Access Laura Cannon/Dee Carri’s presentation here.

My key takeaway from PharmaLink on metrics is that it will be a game changer for the industry. Sideline discussion indicates that implementation will be difficult and expensive. It would, therefore, be prudent for organisations to get ahead of the FDA timeline to avoid business disruption and the risk of non-compliance. How does your organisation measure up?

Telemedicine and Sharks

Are you wondering what telemedicine and sharks have in common? The backdrop to the conference dinner was Newport Aquarium where sharks and other fish floated around and over the speaker as she delivered her address.



Despite the possible distraction, this speech was inspirational, providing an insight into innovations in telehealth delivery and improved patient outcomes in Mississippi. The opportunity for wider applications of telehealth in regular patient management, difficult to access regions and other situations where medical expertise is required fast e.g. the aftermath of natural disasters, is vast. The presentation is not available but I expect we will hear lots more about this topic as Telemedicine goes mainstream.

If you would like to discuss any of these topics contact me.


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