To a packed audience of 100 delegates, Janet Davies, BMS, opened the first DIA Medical Information & Communications two day workshop (part of the DIA Clinical Forum event). Giving an overview of Medical Information in Europe, Janet set the scene, explaining the role often has different job titles and some variation in responsibilities. Companies are increasingly setting up European regional teams to support the smaller markets where people often have multiple job functions (e.g. regulatory affairs, medical information and pharmacovigilance).
Alexander Bedenkov, Schering-Plough, works as a medical advisor for remicade across Centrel Eastern Europe (CEE). Covering a vast region across 12 time zones, he travels extensively to support KOLs and other specialists. The demographics of the Russian and CEE regions are intriguing. Very few HCPs have English language skills and internet/email access is poor so personal visits and phone calls are key deliver channels.
Sabine Lischka-Wittmann, Lilly Deutschland GmBH, tackled the difficult issue of tackling patient enquiries. As much an art as a prescriptive process, she used 3 typical scenarios to demonstrate the clear principles that help to guide us when speaking with patients. Clear jargon free communication, balancing out postive and negative aspects of medicine use and being aware of legal and ethical constraints.
Moving onto the regulatory aspects of medical information, Elke Blaetz, Global Medical Information Leader Roche USA, chaired a difficult session – how to engage the audience when quoting legislation and regulation! We were updated on the new version of the EFPIA code of practice (due for imminent release) from Par Tellner LIF, the Swedish Association of the Pharmaceutical Industry). New sections include relationships with patient associations. Par mainly discussed non interventional studies and disclosure of clinical trials.
Preparing for a regulatory inspection need not be particularly onerous if you are well prepared as Linda Howell, Head of Medical Information, Roche UK. Both practical and logical, Linda took us through best practice before, during and after a MHRA inspection.
Last but not least Genevieve Le Visage, EMEA, comprehensively guided us through the EU regulations, directives and guideance relevant to anyone with a medical communications role.
I had the pleasure of facilitating a workshop on Best Practice (although I like John Barber’s comment that it’s actually Better Practice as there is always room for improvement). The 7 session chairs each worked with a group of delegates to develop guidance on a key business topic. We discussed response times, solicited vs. unsolicted enquiries, support at congress booths, mature products, sales force services, field based teams and patient enquiries. The aim is to create a community to develop the guidance further. The initial work will be posted on the DIA website (for DIA members only).
The ground breaking work of PIPA, the UK association for medical information and pharmacovigilance professionals (www.pipaonline.org), was spotlighted during the last session of the day. Kathy Fowler, Eli Lilly UK informed the mainly European audience about the PIPA guidelines on standards for medical information. As chair of the Standards working party, she explained how the standards were created and given credibility by working closely with a key customer group, the UK Medicines Information Pharmacists (UKMi) in the hospital sector. The latest revisions were triggered by the launch of the MHRA Blue Guide, on medicines promotions.
The service provided to key healthcare customers in the UK by medical information departments across our industry is surveyed on a regular basis. Run by the UKMi collaboration, on behalf of PIPA, feedback on specific enquiries made to companies on one particular day is collected. As this is the fifth survey run by UKMi & PIPA, industry services can be benchmarked. Janet Taylor, an independent consultant, presented the latest results that she analyses on behalf of PIPA, hot off the press! Overall the service provided by industry is good in 88% of instances. New trends include a declining need for medicines information pharmacists to contact companies, driven by the availability of up to date SPC information on the Electronic Medicines Compendium website. Access to companies continues to be an issue. Extrapolating the results would mean that 3000 medical information calls from UK Medicines Information Pharmacists per year don’t reach the right person. Yet almost half of calls to companies relate to current patient management.
John Barber, current PIPA President & Director Scientific Affairs, Alliance Pharmaceuticals, presented the industry competency framework for medical information professionals in the UK. Although many larger companies may have their own competency tools, PIPA developed the framework to sit alongside the guidelines on standards and help determine current training needs for professionals. Frameworks like these can also help the recruitment process, self development plans and performance management.
So what happened on Day 2? Who pensioned off their global website?