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The Challenges of continued professional development
Continued Professional Development (CPD) within the pharmaceutical industry requires considerable investment in terms of time, money and resources. For the small to medium sized enterprise (SME), where budgets are constrained, the costs associated with CPD can increase staff overheads considerably. Often a company considers staffing costs in terms of annual salary and annual leave. However, in the pharma-industry it is important to include additional staffing expenses such as training courses, travel, accommodation, and not to mention the loss of their time whilst away from the company.
Having gone through another MHRA inspection, on behalf of another of our clients, it appears the same things keep cropping up year upon year. The big question for SMEs on how best to manage the legislative requirements for continued professional development.
So, what exactly does the legislation require?
‘All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training. For marketing authorisation holders, this training shall relate to the roles and responsibilities of the personnel. ‘
The legislation goes on to say…
‘The training should support continuous improvement of relevant skills, the application of scientific progress and professional development and ensure staff members have the appropriate qualifications, understanding of relevant pharmacovigilance requirements as well as experience for the assigned tasks and responsibilities.’
Training courses vary much in price, starting at a mere £75 for a quick 1-hour online training module, increasing to an average £350 for a one day external ‘face-to-face’ training course and extending all the way up to a whopping £2750 for a certified 3-day course with esteemed colleagues from specialist areas. The selection and scope of training can become a minefield and knowing how to navigate through these choices can take time and effort.
Since the MHRA expect companies to use formal, external training providers, we asked the authorities whether the MHRA would consider providing a list of recommended external training courses. The reply was a prompt passing of the buck, with the statement ‘The MHRA does not and cannot recommend specific training courses.’ This is understandable if the MHRA wants to take a non-promotional stance. However, surely to promote minimum acceptable standards within the industry, the authorities could provide some guidance on what would be deemed acceptable.
So, what should we be looking for to ensure we get value for money?
Research on finding out how to ascertain whether a CPD course is accredited or not is not as easy as one might think. The scope of what companies use to provide CPD extends to workshops, conferences and events, e-learning and attended training courses.
The use of opportunities provided by regulatory bodies and professional associations are always great places to start. For the UK this would encompass the Medicines and Healthcare Products Regulatory Agency (MHRA), Association of the British Pharmaceutical Industry (ABPI), Pharmaceutical Information and Pharmacovigilance Association (PIPA) and The Organisation for Professionals in Regulatory Affairs (TOPRA).
The CPD certification service is a UK organisation for external training organisations to ensure their materials meet global standards. See their member directory on: http://www.cpduk.co.uk/index.php/cpd-members. Both the Management Forum and Pharmaceutical Training International are members of this body.
Alternative methods for accreditation are the use of industry experts who may either provide the actual course materials, or review and approve course content. The BMJ Learning Platform uses this approach, whereby various industry specialists and institutions have provided CPD accreditation points to various courses.
Moving further afield you want to make a note of other institutions such as Cooperative European Medicines Development Course (CEMDC), European Innovative Medicines Initiative (IMI) and the Pharmaceutical Medicine Training Programme (Pharmatrain) which are group of organisations involved in addressing standards in education and training in the sciences of pharmaceutical medicine and drug development across the European Union. The European Federation of Course Providers in Pharmaceutical Medicine (EFCPM) is another learned society and is linked with the European Federation of Pharmaceutical Industries and Associations (EFPIA). The Drug Information Association and MSSO/MedDRA are other training institutions to be aware of in pharmacovigilance.
So, accreditation or certification reassures us course content is up-to-date, complies with current legislation, has undergone some sort of professional review, and uses industry specialists or expert trainers. In addition we want to know that course content is reviewed periodically for applicability, improvements and remains on trend with global markets and scientific developments.
Whilst e-learning platforms are cheap and accessible, you only get what you pay for. So, quality over quantity is the principle we’re going for. We want to ensure a good return on investment for the company, the participant and ultimately our clients.
Professional enquiry handling to support the safe and effective use of your products.
Ease the regulatory burden and keep compliant with current pharmacovigilance legislation.
Product safety through surveillance of published articles and case reports.
Confident staff to support the pharmacovigilance process.
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