Workshops
Sample Programs: Charting the Course in Compliance with the PDMA
Monday, May 20 • 2:00pm-3:00pm
Dive into the intricacies of pharmaceutical compliance with our new PDMA workshop designed to demystify the Prescription Drug Marketing Act.
Join experienced industry professional, Keisha Cosey, as we explore comprehensive insights into the regulatory landscape ensuring a deep understanding of compliance essentials.
This interactive session with expert guidance will equip you to navigate the dynamic world of sample compliance with confidence.
So arrive early before the official conference kick-off starts, and bring all your PDMA questions.
You won’t want to miss this important extra learning opportunity offered to conference attendees at no additional charge.
Exploring the Frontiers of Generative AI: A Practical Look Through Professional Networking
Monday, May 20 • 3:00pm-4:00pm
Join Jay Lambert, Artificial Intelligence Evangelist and Trainer with the Vjal Institute, on a journey into the heart of Generative AI, tailored specifically for professionals eager to navigate its vast potential.
During this hot-button session, Jay will dive into:
Foundational Insights: Starting with the basics by breaking down Generative AI’s core principles into digestible, relatable concepts. Jay will share from his own experiences how these technologies have piqued his curiosity and fundamentally reshaped his approach to professional digital interaction.
A Year of Transformation: Reflecting on the past year, Jay will walk attendees through recent changes in the rapid advancement of AI, discussing the milestones that have notably expanded what we can achieve with it. He will highlight how these developments have opened new doors for us all, making AI tools more powerful and accessible than ever.
Generative AI in Action: Jay will use real-life examples to show how Generative AI, particularly through custom GPTs, is revolutionizing the approach to professional networking on LinkedIn. From crafting engaging posts to enhancing personal profiles, insights shared will be aimed at empowering attendees to harness AI for their own professional growth.
This learning session is more than a presentation – it’s a conversation about where we stand with AI and where we’re headed, especially in professional networking.
So whether you’re deeply invested in AI, looking to boost your LinkedIn game, or simply curious about the buzz around AI, you’ll leave this workshop with new insights, practical strategies, and perhaps a bit of passion for the transformative power of AI in our professional lives.
You Can’t Make This Stuff Up!
Monday, May 20 • 4:00pm-5:00pm
Everyone in our industry has at least one “you’ll never believe this” story they’ve encountered along their professional journey.
For example, Alliance Executive Director Deb Segura tells a story about a rep reporting lost sample boxes one December. Then in mid-January, the missing sample report was withdrawn when the rep took down her Christmas tree and discovered all the sample boxes had been giving the tree some additional height hidden under the tree skirt!
In this special pre-conference session, our panelists will share some outrageous stories, offer a look back and laugh at some unbelievable moments, and prepare us for the next two days of learning so you’ll know what to do when you’re in a what-not-to-do situation.
Audience participation will be encouraged, so bring your logistics, samples, and compliance stories and join us for a good discussion and a few laughs before the official start of this year’s Sharing Conference.
Changing Behavior through Engaging Compliance Training
Tuesday, May 21 • 9:30am-10:30am
Do you need to change BELIEFS before you change BEHAVIOR?
In this new-to-our-agenda workshop “Changing Behavior through Engaging Compliance Training”, industry training expert Julianne Brierley will be giving attendees a look into the development of compliance training that actually works for the long haul.
If your goal is to encourage long-term training retention, and to create behavior change, then how you deliver your training is just as important as the training itself. In this engaging new learning session, Ms. Brierley will show you how to move beyond completion as the sole goal of compliance training.
Discussion will include what you need to know to deliver impactful, engaging and measurable training to the right people, at the right time, all the while working toward an end goal of successful long-lasting results.
The Compliance State of the States
Tuesday, May 21 • 9:30am-10:30am
The Sharing Alliance is pleased to offer attendees a new take on a hot topic presented by well known industry experts David Smith and Brian Van Hoy.
An often requested subject for our conference attendees, this learning session will include a review and discussion of current and proposed State regulations that impact the US drug and device industry. Compliance categories include manufacturer and employee licenses, compliance program registrations, approval notifications, price reporting and disclosures, take-back programs, privacy, sample programs, transfers of value, and more.
Don’t miss this comprehensive overview of the current and ever-changing State requirements to ensure your company is currently in compliance with the State requirements. Discussion will also include how to be confident your organization is properly prepared to comply with the pending requirements.
The Challenges of Today’s Logistical Landscape
Tuesday, May 21 • 1:30pm-2:30pm
Both before and after the covid shutdown, many elements of our supply chain (especially those related to transportation services) experienced changes large and small. Among these are potential strikes and other work stoppages, large carriers closing their doors, a reduction in resources (including talent), and even new procedures and services that may surprise you.
Our two presenters, both experts in logistics, know first-hand what it’s like to deal with an evolving logistical landscape. Steve Conn and Mike Murphy are ready to share their knowledge with real life examples of these and other obstacles pharma companies are facing in the current world of logistics and supply chain. They will address different types of challenges, discuss best practices and dive into what the future may have in store in the realm of logistics.
Attend this workshop and bring your own logistical challenges to talk about with the group. Lively discussion is guaranteed!
Roadmap to Fleet Operational Excellence
Tuesday, May 21 • 1:30pm-2:30pm
Sharing Alliance Board Members and Industry Experts Gina Israel and Debbie Tay will be bringing a wealth of information and personal experience to this constantly evolving topic. They are well-prepared to present a comprehensive workshop on mastering the fundamentals of fleet management.
Whether you’re suddenly faced with the responsibility of managing a fleet, or you are seeking to refine your existing program, this learning session will provide attendees with the essential knowledge and skills to optimize their fleet’s performance.
Discussion will include how to develop effective policies and procedures, and strategies for selecting the right vehicle, including introducing electric vehicles to your fleet. There will also be conversation on deploying safety strategies for improved fleet management, so come with all your questions and be ready for a lively look at fleet management.
Who’s Minding the Shop? How to Monitor and Provide Oversight Over Your Vendors
Tuesday, May 21 • 3:00pm-4:00pm
When you’re auditing and monitoring your sample transactions, how can you be sure your vendors are conducting their tasks properly? Trust but verify.
Yvette Gaines and Marc Lavin, Sharing Alliance board members and leading pharmaceutical industry experts are ready to walk you through the process of knowing what to look for, from findings through follow-up. They will discuss best practices for auditing and monitoring vendor processes and documents, and offer examples and case studies to support their presentation.
This will be an interactive session so bring your questions and considerations, and be prepared for a fun and lively discussion!
More Than a State of Mind: How State Licensing Impacts Product Distribution
Tuesday, May 21 • 3:00pm-4:00pm
The importance of being properly licensed with each state to sell and/or distribute your products should not be overlooked. How you are licensed with a state depends on your operational activities for that specific location. When it comes to what licenses are needed and who must obtain them, no two state requirements are the same.
In this workshop, Lisa Butler and Liz Updike, two powerhouse experts in the state licensing space, are well-prepared to share their extensive knowledge on this topic with you. Attendees will get an overview of both Commercial and “Sample” distribution licensing and learn about the intricacies of both.
This collaborative learning session will allow time for attendees to share their own challenges and learn how other companies manage the expectations of the individual states. So come join your industry peers in an interactive workshop that will surely be as educational as it will be engaging.
PDMA Readiness: Are You Prepared for an Inspection?
Tuesday, May 21 • 4:00pm-5:00pm
Are you familiar with the FDA’s Inspection Guidance for the Enforcement of the Drug Sample Distribution requirements of the Prescription Drug Marketing Act (PDMA) compliance manual?
Join us at the Sharing Conference this May, where proficient PDMA Specialist Rick Hughes will be leading a workshop review of the inspection guidance update/replacement (March 2013) for the FDA Compliance Program Guidance Manual 7356.022 Investigations Performed under the Prescription Drug Marketing Act (PDMA).
This learning session will outline how the FDA conducts investigations of individuals, drug manufacturers, distributors, and other parties that may be involved in prescription drug sample theft, loss, falsification, or diversion. Discussion will also include the FDA’s general guidance concerning inspection of firms for compliance with recordkeeping and monitoring systems required under the PDMA.
Recommendations will be presented on how to prepare for an inspection/audit. Mark your calendars and plan to attend to hear this valuable analysis of vital information.
DSCSA! Drug Supply Chain Security ACT, or AGGRAVATION?
Tuesday, May 21 • 4:00pm-5:00pm
A compliant and secure pharmaceutical supply chain is not only essential to operate, but most importantly required to ensure patient safety. The Drug Supply Chain Security Act (DSCSA) enacted by congress on November 27, 2013, created a road map for the supply chain to follow. While industry is still in the final stabilization phase, closely approaching are the final phases to completion and full FDA enforcement. All stakeholders in the supply chain have been impacted by this rigorous and costly process and must comply to continue operations and provide lifesaving medications to patients and combat drug shortages.
In this workshop presentation, industry expert Brad King, who has been on a DSCSA Serialization Project Team since 2014 to date, is well prepared to share his extensive knowledge on this topic with you. Attendees will get an overview of the phase in periods for Manufacturers, Repackagers, Wholesalers, 3PLs and Dispensers along with current challenges faced by industry during the stabilization period in meeting the enforcement requirement deadline which was originally scheduled for November 27, 2023, the implementation of core requirements has now been postponed to November 27, 2024. Areas such as audits and enforcement by FDA and State Board of Pharmacies will also be covered.
Join your industry peers in this new workshop that will get you up to date on DSCSA and provide you with some valuable information to bring back to your organization.
The Reconciliation Cycle
Wednesday, May 22 • 8:30am-9:30am
Performing a PDMA Reconciliation should not start with distributing reports to the field sales force. Agree or disagree?
Let’s talk about it when you attend this workshop led by two long-time pharma industry professionals with extensive knowledge on PDMA. We will be discussing PDMA guidelines and industry Best Practices, and the necessary tools to assist you with preparing for the all-too-important reconciliation cycle.
Also in this learning session, you will gain an enhanced understanding of reviewing sample transaction(s) that impact FDA Reportables and anomalies in your data. We will look at validating and documenting an objective process for escalation. And, once the reconciliation cycle has been completed, we will talk about how you can ensure you are closing the loop with follow-up activities such as field training. Then, last but certainly not least, we will discuss how to create and track metrics related to the cycle.
How much can companies assist the rep with the reconciliation process? Attend this workshop and get the answer to this, and so much more!
Storage Unit Management: Securing your Company’s Assets, a Behind the Scenes View
Wednesday, May 22 • 8:30am-9:30am
Let’s be honest. If it’s your responsibility to oversee storage unit management for your organization, it can be a real headache.
The intricacies of storage unit leasing and management are monumental and key to ensuring that your company’s assets are highly secure and easily accessible.
In this new workshop, Ruby Ramirez and Derek Scarsella, two industry leaders with extensive logistics experience, will present a behind the scenes look at solutions through evolution that use real examples to delve into essential guidelines for self storage management.
This learning session will be an open discussion and sharing of best practices, so bring your questions and come ready for good conversation.
Connecticut! Adding to our Transparency Reporting Woes
Wednesday, May 22 • 11:00am-12:00pm
Feeling distressed about the new Reporting Template for Connecticut?
Then don’t hesitate to join notable industry leaders, Judy Fox and Allyson Knott, for a rousing discussion on this very timely topic.
Manufacturers were required to register for the first time with Connecticut by October 1, 2023 and registrations must be renewed before July 1, 2024.
During the renewal process, manufacturers are required to file a report that includes:
– The aggregate number of contacts such pharmaceutical sales representative had with prescribing practitioners and pharmacists;
– The specialty of each prescribing practitioner and pharmacist with whom such pharmaceutical sales representative made contact;
– Whether product samples, materials or gifts of any value were provided to a prescribing practitioner, practitioner’s staff, or to a pharmacist; and
– An aggregate report of all free samples, by drug name and strength
Make plans to attend this new to the Sharing Conference workshop. Conversation will focus on a deep dive into the reporting template issued by the state of Connecticut, with discussion on some of the challenges facing manufacturers in complying with the reporting requirements by July 1.
State Loss Reporting and Aligning with FDA, DEA and State Requirements
Wednesday, May 22 • 11:00am-12:00pm
Think you have the world of reporting all locked down?
Come join this material-rich, enlightening workshop and you will definitely walk away with some very useful information.
Our skilled presenters have an extensive history in the industry and they are well-prepared to share their background and knowledge by providing attendees with what’s needed to stay compliant related to reporting.
This learning session also offers an historical perspective on the why of where we’ve landed by placing accountability and reporting requirements directly on the drug manufacturer. Distinctions will be drawn regarding separate types of reporting at the federal and state levels, specific timelines for each, the investigative process, and, which states have more stringent requirements than the FDA.
Don’t miss this informative workshop filled with facts, insights and the kind of discussion you can’t find anywhere else.
Harmonizing Communication: The Rhythm of Audience Engagement
Wednesday, May 22 • 1:30pm-2:30pm
It’s time to experience the Art of Engagement!
You’ll enjoy spending time with our two highly accomplished presenters who also happen to have a fun and upbeat way of approaching everything. You’ll elevate your communication skills with this new and exciting Harmonizing Communication workshop. Discover how to blend music and message for unforgettable presentations. Learn, interact, and be entertained as we explore innovative engagement techniques through live music, quizzes, and interactive exercises.
This session promises not only valuable insights but also an opportunity to network and have a good time. Ready to transform how you connect with your audience? Don’t miss this workshop where learning meets rhythm, and every moment is a chance to engage.
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