August 26, 2015
Disclaimer


 
For those of you that know me well and or have worked with me throughout my career in the Life Sciences industry, you will hopefully recognize the following question without too much difficulty:
How do you know what to do if you don’t know where you are? This question can apply to a variety of scenarios within our personal and professional lives, it is true, but I often apply it in relation to the nomenclature within the Life Sciences Industry. To be more specific, I could also ask, How do you know what you are going to do if you don’t know how to explain it?
My previous and current colleagues smile — or at least I think it is a smile — when I reference a piece of work I had the honor of creating for a past employer of mine. What is it you ask? It is a Definitions Document, one that originally took one year to assemble due to the complexities of the industry and, of course, because I was working within a committee. Designed to get every stakeholder using the same language and definitions around the engagement types or meeting types within the company proved to be somewhat daunting, but in the end the company and its stakeholders embraced it and it remains part of their SOPs today. Medical Meetings / Meetingsnet.com continues to post this article, now with an infographic to walk meeting professionals, suppliers and even hoteliers through the terminology of medical meeting types and processes. Previous clients of mine continue to thank me, because it has lifted the veil of confusion and now allows them to identify where their sponsors or clients are, what meeting types they are trying to hold as well as the specific processes that need to be followed — particularly from a compliance and regulatory point of view. These definitions provide greater understanding of what questions to ask in the qualifying process leading to increased efficiencies and afford the service provider heightened confidence to perform their job functions.
Although primarily focused on the definitions of the meeting types that healthcare professionals attend; additional meeting types or interaction types were also identified and used to showcase the fundamental education necessary to be consistently successful in achieving the meeting objectives.
A meeting is a meeting is a meeting, isn’t it? One would think so, as the commonalities of logistics include choosing a date, location and who needs to attend — oh yeah, and what food and beverages will be served during the event. All those factors are collectively important but, in the Life Sciences world, especially when and where you have one or more healthcare professionals in attendance at a meeting or event, the rules are different.….The title and definition of a meeting or engagement type can have a significant impact on processes used, monitoring and auditing performance, internal and external perception, and even profit and loss statements!
I learned this by experiencing an audit many years ago. Our internal auditors came from different departments within the company and had what I thought was a good breadth of knowledge. Many of them had understanding of how the commercial side of the house ran, but not the clinical or development area of the business. They were auditing my department’s work which, was primarily in the clinical space (study-related meetings: investigator meetings, FDA hearings etc.). Based on the assumption that similar titles meant similar thing they assumed that an Advisory Board on the commercial side would have about the same objective, business need and rationale as a Clinical Advisory Board in my world. Similarly, they perceived that an Expert Panel was the same as an Advisory Board. Of course, that is SO not the case. Sure there are Key Opinion Leaders there to offer guidance or expertise, but the absolute objective as well as the regulatory requirements are quite different.
In addition to that natural confusion, due to mergers, acquisitions and just plain transition as colleagues move from one company to another carrying with them their experiences, processes and yes, terminology, this misunderstanding can grow. Of course, no one in particular is to blame for this. However, I learned quickly that this was going to cause problems during my audit and future audits if not addressed and rectified!
It is the same principle as garbage in, garbage out….
We were being audited on processes that were aligned to a different division within the company. Expectations, standard operating procedures, financial codes, HCP caps and meeting budgets were all outlined and dovetailed into specific meeting types. When auditors reviewed our meeting files, they were holding us to a different set of processes etc. Nothing lined up to the auditors’ expectations nor did it support the company’s commercial SOPs because this was the clinical side of the house. We were held to a different set of rules. Identifying this quickly saved our skin in the end, passing the audit successfully, but it resulted in an extended audit period — 2 months to be exact! We had to painstakingly but essentially educate each of the auditors on the clinical side, its nuances and similarities as well as the difference of processes, stakeholders, attendees and rules. Quite the eye opener for all!
So whether you are a meeting professional within a Life Sciences organization, an independent planner servicing your Life Sciences clients or other service providers touching medical meetings, especially those meetings that have HCPs in attendance, reference this infographic — even wallpaper your cubes with it! You will save time, avoid costly errors in contracting, auditing and even evade potential pitfalls of negative internal or external perception.
 

Contributed by:
 

Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.

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