Don't let the fear of non-compliance
scare you this Halloween!
When entering the world of life sciences meeting management, take the time to establish a course of action that works best for you and helps set you up for future success.
Our last article, "5 Tips for Combating Compliance and Policy Challenges in the Execution of Global Pharmaceutical Meetings," addressed critical tricks for compliantly designing your meeting within regulatory limitations.
We talked to Michelle Bartolone, CMP, Chief Executive Officer, Meeting Sites Pro, Inc., who provided us with 3 more tips to add to your toolbox!:
1. Create a deviation log
Deviation logs are the key to success when managing healthcare meetings. Staying organized and recording changes plays a pivotal role. If you don't know what deviation logs are, don't miss Michelle's presentation at this year's Pharma Forum event to find out how to incorporate them into your meeting's compliance strategy.
2. Know the difference between guidelines and law to successfully manage meetings.
When you have to balance internal corporate compliance (meeting policy, travel policy, data protection policy, brand requirements, etc.) with country requirements (meal caps, transportation and venue allowance), and Pharmaceutical compliance (ICH transparency requirements), knowing what you must adhere to is the first step to setting your meeting up for success!
3. It’s important to understand the acronyms specific to an industry. Can you identify what these acronyms are and what they mean and how they may affect your meetings?
- OIG (Office of Inspector General)
- CIA (Central Intellegence Agency)
- CMS (Centers for Medicare & Medicaid Services)
- FMV (Fair Market Value)
According to MeetingsNet.com, In 2012, 35 countries had some type of compliance reporting requirements. “Now 89 countries have some sort of code, regulation, or guideline” related to transfers of value, or TOVs, from a pharmaceutical or other life sciences company to HCPs—in fact, the Economic Intelligence Unit predicts that 70 percent of pharma sales this year will be made in countries that have transparency laws.
Join Michelle Bartolone at Pharma Forum 2018 where she will be leading the session, "Compliance 101 – Developing a Toolkit for Compliant Meetings"
About Michelle Bartolone
In 2000, Michelle Bartolone launched Meeting Sites Pro, Inc. a full service worldwide meeting management company. In 2003, she also founded CME Pro, Inc., a continuing medical education firm, which was accredited by the ACCME and other organizations to provide continuing education programs for physicians, nurses, and other healthcare professionals. Through the years, Michelle has gained extensive healthcare industry experience and has helped her organizations and clients stay informed about the ever changing HCP regulatory compliance environment and reporting requirements.
In January 2014, Michelle launched SM Squared (SM²), a full service worldwide meeting management company exclusive to the pharmaceutical, medical device, and biotechnology industries. SM² specializes in and is well versed on the compliance complexities that face these industries. In 2014, Michelle and Kevin Harty (Vice President) were two of the first 54 industry leaders in the country to earn the Certified Meeting Professionals subspecialty for healthcare meetings, the CMP-HC.
Michelle serves as a member of the newly formed Certified Meeting Professionals Governance Commission by the Convention Industry Council of America to govern the CMP program and further the future of our profession. Over the past decade, she has served as an advisor and speaker to many clients and associations to educate on regulatory requirements and best practices. In the past 8 years, Michelle has been recognized four times by the San Diego Business Journal for the Women Who Mean Business Award.