It’s no secret that compliance professionals are faced with an ever-changing environment of state and federal regulatory requirements. Staying compliant requires more diligence and resourcefulness than ever before. But having the underlying knowledge remains paramount; it is extremely difficult to fully comply with something that is not properly understood. Successful compliance requires an in-depth understanding of both the big-picture goals of regulators and the practical nuances of applied best practices. Learning and knowledge-sharing are the vehicles to that understanding.
Today’s expanded vision of compliance learning and sharing includes exploration of important issues such as the safety and security of our drug supply chain, drug sample distribution and other marketing initiatives, transparency requirements, fraud and abuse, ever-changing state regulations, and much more. That’s why 2017 marks a significant milestone for The PDMA Alliance: our transition to a new brand identity.
In 1990, a small group of pharmaceutical executives responsible for compliance to the Prescription Drug Marketing Act of 1987 (PDMA) came together to discuss the relatively new PDMA and how it was impacting their work days. They shared ideas and networked on issues related to sample accountability. The group continued to meet annually and grew to become The PDMA Alliance, a not-for-profit organization. The PDMA Alliance was founded “by the industry, for the industry” as the voice of pharmaceutical, medical device and biotech compliance professionals.
Over the following 27 years, the Alliance has expanded its knowledge base well beyond the Prescription Drug Marketing Act of 1987, incorporating new content each year to reflect the challenges facing our members: OIG guidelines, corporate integrity agreements, Open Payments, aggregate spend, investigations, the Drug Supply Chain Security Act, 340B drug pricing program and more.
To complement this new knowledge, we recognized the need to modify our identity. Over the next few months, you will see our brand fully evolve from The PDMA Alliance into The Sharing Alliance. Our rationale for this is sound: We are well aware that the issues challenging pharmaceutical, medical device and biotech compliance professionals are both broad and deep. Most certainly, compliance with the PDMA remains an important industry concern, and we will continue to share our expertise in this area with our membership. But as pharma, biotech and device compliance needs have changed and multiplied, the Alliance has expanded in response. We haven’t lost touch with our roots and still consider ourselves to be the premier resource on PDMA compliance; instead, we’ve expanded to deliver even more to the compliance community.
Who is The Sharing Alliance?
Our organization is comprised of people like you: professionals at pharmaceutical, medical device and biotech companies who work in compliance, marketing, legal, sales ops and other job functions who are motivated to help address the health concerns of our nation while adhering to federal and state regulatory mandates. They attend our annual conference and become year-round members of our learning community. Some even volunteer to serve on our Board and work together to identify ways the Alliance can better serve its members.
The Alliance maintains good relationships with the US Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), the Office of Inspector General (OIG) and other agencies to continually understand and educate the industry on pharmaceutical, biotech and medical device compliance business, and security best practices. The Alliance Board is committed to the ongoing expansion of the not-for-profit Alliance by supporting members through dynamic pharmaceutical industry changes and challenges.
Our mission is clear: to improve the understanding of laws and regulations that most impact the compliance professionals that make up our membership; to help facilitate the communication and sharing of compliance best practices; and to continue the legacy of excellence the Alliance has held for more than 25 years.
Clearing the path
This October, there is a real opportunity at the 2017 Sharing Conference to gain insights about the most important compliance issues that are surfacing from our changing culture. Together, compliance specialists will have the opportunity to rid themselves of obstacles that cloud the path to a clear vision.
Our program is chock full of learning opportunities, with more than 20 sessions over two and a half days. Attendees will hear from speakers representing the US Government, the biopharma industry, the medical device industry and the vendor community that supports the conference.
CMS Town Hall
The Alliance continues to foster communications between industry and CMS. At the Sharing Conference, attendees will get the opportunity to have transparency reporting questions answered directly from CMS Open Payments representatives, led by Robin Usi, director of the Division of Data and Informatics (DDI). Questions for CMS can be sent in prior to the conference or during the Town Hall meeting itself. Previous attendees have told us that these Town Hall sessions are a great way to get clarification on specific requirements while providing a platform to alert CMS to specific challenges manufacturers face when compiling federal reports.
FDA and OIG Participation
Over the past 25-plus years, the Alliance has been privileged to have members of FDA, CDER and OIG regularly present at the Sharing Conference. Plans for this year’s conference are ongoing; detailed announcements on speakers and topics will be posted to sharingalliance.org and sent via email notification. You can join our mailing list by using the Contact Us link on our website.
No compliance event offers as many learning opportunities in 2 ½ days as the Sharing Conference. This fall, we will be delivering more than twenty, hour-long workshops on diverse topics, including:
- Culture, ethics and compliance
- DEA: selling & promoting high-risk drugs
- Successful compliance training strategies
- Risk-based monitoring & auditing
- Preparing for a transparency audit
- Project management: doing business using lean principles
- Techniques for easing system implementations
- State legislation: panel discussion
- Ensuring quality and product safety in cold chain distribution
- Hospital credentialing risks
- Compliance 101 for pharmaceutical & medical device professionals
- Ensuring compliance in sample delivery processes
- Data integrity: keeping up with HCPs on the move
- Aligning US transparency initiatives with global requirements
- Sampling data analytics
- Field monitoring
- Fraud and abuse of co-pay cards, coupons and vouchers
- Sampling limits: how much is too much?
- Successfully partnering with a contract sales organization
- New technologies for data management
As always, the learning session agenda will also include our “Sharing” forums. Attendees value the chance to discuss any and all compliance-related subjects with conference colleagues in this interactive open forum setting.
Speed learning sessions
Our conference agenda also includes eight “Speed Sessions” designed to provide attendees with a 15-minute introduction to important, emerging issues. Scheduled topics include:
- Serialization update/DSCSA/FDA/DQSA
- 340B Audits
- The opioid crisis
- UDI—medical device security, tracking and protection
- Drug stewardship and Take Back overview
- You asked, the Alliance got you answers
- Life After a Corporate Integrity Agreement (CIA)
- Rep-facilitated meeting requirements
Special Guest Speaker
As this article went to press, the Alliance was finalizing plans to add an exciting Special Guest Speaker to our agenda. This guest is likely to keep attendees on the edge of their seats with a story that is exciting, engaging and motivating. His headline-making experiences are sure to be a can’t-miss hour. Make sure you visit sharingalliance.org regularly for this important announcement.
As you can see, 2017 is an eventful year for both the Sharing Alliance and the Sharing Conference, which means it’s also an eventful year for our Alliance members. We’ve expanded our content. We’ve sharpened our focus. We’ve rebranded to better identify what we offer. And we’ve gathered an impressive collection of speakers and presenters to deliver some very important information. If you haven’t already registered to attend the conference and become an Alliance member there’s still time. See you in October!
ABOUT THE AUTHOR
Deb Segura is executive director of The Sharing Alliance (formerly known as The PDMA Alliance; www.sharingconference.org).