This year’s PIPA Annual Conference held in Denham Grove, UK on 14th- 15th Oct 2015 started out with a great plenary session from ABPI Chief Executive, Dr Virginia Acha, on the topic of “Evaluating the Safety of Medicines”. Essentially asking when do we really know the value of medicines? Product lifecycle management and continued evaluation is highly regulated in terms of the industry and the regulators themselves but less prescriptive is the rest of what should be the heart of ‘patient centred’ benefit and risk evaluation involving the clinicians, pharmacists, Health Authorities and media to name but a few and how that collaboration needs to be addressed. Focusing on this Virginia outlined some of the key trends, opportunities and challenges for the evaluation of the safety of medicines.
This was followed by Alex McLaren, from the Spontaneity Shop talking about Charismatic Impact. What equals charismatic behaviour? Looking into high vs. low status body language changing us all from uncertain attendees at the conference on day 1 into our own charismatic and influential Oprah Winery’s.
Sticking with the soft skills that PIPA has been adding to the agenda recently, I attended the Dealing with Difficult Customer’s breakout session again led by Alex McLaren.
Firstly we investigated what some of these difficulties are within our industry. One example was from some of the Medical Information people who were in the room, explaining how they are dealing with patients and the tough conversations they have on the phone, keeping in mind that they are required to stick to the APBI code of practice. Similarly how to maintain your high status (reference from his earlier session) in negotiation for example with sales force demands. However one practical take home for me was actually a nice way to introduce yourself using a partner you just met and spoken to about your name and where it originated from, which I have since adapted for use while presenting training workshops in Argus.
Day 2 started with a general session on the Yellow Card Road Map, by Phil Tregunno from MHRA. Given that it is now the 50th anniversary of the yellow card scheme in the UK, the MHRA are still very much involved in maximising patient public safety though new initiatives and strategies in the ADR reporting system. Amongst the improvements sited were tighter integrations of the yellow card integrated with the GP systems of choice, introducing network safety officers into the NHS, launch of the yellow card app (WEB-RADR collaboration and initiative).
During the Thursday morning session Julianna Callaghan from Cancer Research UK gave us all a fantastic insight into the full drug development capabilities that the CRUK centre is involved in. As well as the charity being the largest funder of cancer research in the world they take first in class and first in humans from preclinical through to early phase II trials. In addition the CRUK partnership in academia and industry take drugs that may otherwise be on hold, or novel agents, and progress them on through their collaborations. What struck me was how little most people knew about the work CRUK do in the clinical setting and with 5 products to market within 400 studies how the success rate is equivalent to industry.
I then attended the Pharmacovigilance track which kicked off with a presentation on Risk Management Plans and Risk Minimisation Materials, from Dr Kathryn Ord at the MHRA. Although RMPs have been around since 2005 the new legislation in 2012 introduced them for all new drugs and set up the Pharmacovigilance Risk Assessment Committee (PRAC). As ever the regulations are a moving target and GVP module V is currently being revised and will then be out for consolation. Likewise with GVP XV Safety Communications and GVP XVI Risk Management Measures and the addendum on education materials only just released on 16 Dec 2015 there is more guidance on what to include and what not to include. However tracking of RM materials and use of digital media still remains a challenge.
Peter Carroll, Datapharm then talked about, ‘Going digital with Risk Minimisations Materials (RMMs)’, tackling the burden to distribute educational and RM materials. Using Electronic Medicines Co (eMC) website to log all these materials is far outstripping the conventional methods after a successful pilot in 2014, 30+ companies are now signed up.
Then, onto the break out session on how to keep quality standards high with Sue Rees, Amgen and Janet Davis, Gilead. We set out to define what we understood by quality in general, i.e. what defines high quality as opposed to low quality. In terms of industry practice it could be said to roughly translate that quality is meeting minimum standards while high quality is meeting or exceeding customer standards.
For me the annual conference is a great opportunity to keep current with latest topics of interest, not just through the sessions but by being able to have the time set aside to network with peers, catch up with colleagues and friends and learn about where everyone is going. As always an interactive and memorable dinner event with plenty of fencing practice (yes, real fencing) just adds to the bond of our classic ‘small world’.
I can only say I look forward to the next PIPA event, keep up the good work!
For further information, please contact Cheryl James, pharmasol at email@example.com