Join us for an insightful workshop at the Sharing Conference as we explore how to leverage data for enhanced compliance monitoring and actionable business insights. In this session, we’ll dive deep into:

Sampling Data Insights
What does your data really tell you about compliance risks and business outcomes? Learn how to interpret sampling data to uncover hidden issues and drive decision-making.

Compliance Data and Analysis
Is your organization at risk? Discover how data can reveal departmental red flags and guide proactive risk management.

Effective Data Monitoring
Understand the techniques and tools to monitor data for risk identification and ensure robust compliance processes.

Actionable Insights
Gain the knowledge to turn raw data into strategic insights that support both compliance and business success.

Don’t miss this opportunity to empower your team with actionable data-driven strategies!

As companies continue to embrace digital methods to enhance and streamline internal operations, they are simultaneously exposed to significant risks on a daily basis. Sensitive data keeps piling up, going from person to person, department to department, while constantly increasing security risks of exposure.

In this workshop, topics will include establishing and maintaining privacy policies that protect an organization’s sensitive information and ensure compliance with relevant regulations.

Whether privacy is considered part of your primary role within your company or not, protecting sensitive data for your company, your colleagues and yourself is everyone’s responsibility.

Attend this workshop for an interesting discussion, and bring your questions for a lively Q&A on this important topic!

The FDA Compliance Program Guidance Manual on the enforcement of drug sample distribution requirements of the PDMA (Program 7356.022) directs the FDA Inspector to inquire about all of the programs the manufacturer utilizes to distribute prescription drug products at no cost.

Are you aware of the company’s free drug programs that may exist in addition to the Free Drug Samples? For many companies, this may include Patient Assistance Programs, “Free Trial or Insurance Delay” programs, and “Product Replacement Programs.”

This workshop will cover various types of Free Goods Programs and how they are different from a regulatory and risk perspective.

By understanding the differences among the various programs, you’ll learn how to assess and manage compliance risks more effectively, ultimately improving your organization’s existing compliance program.

Ensure you’re equipped to handle the complexities of Free Goods Programs and their regulatory requirements.

Brand and Sample Strategy changes can affect how field representatives are required to execute your organization’s sample policies and procedures. This workshop offers expert insights and reliable strategies to help you manage changes to your company’s sample procedures.

We will discuss proactive measures, including:

• Evaluating the representatives’ learning curve
• Assessing additional training needs for the field sales force
• Recommendations to assist the field during the transition

Successful process execution requires alignment with both internal and external stakeholders, including the sample department and third-party vendors, to ensure effective communication and collaboration throughout the transition. The workshop will also recommend tools to implement post-change, such as focused retraining, monitoring outliers, and using metrics to improve execution in the future.

Finally, we will emphasize the importance of completing the cycle by promoting the steps taken and aligning with key stakeholders.

This engaging workshop will delve into the intricacies of managing pharmaceutical sample programs, focusing on data-driven strategies to optimize distribution and ensure compliance. Attendees will discover how to:

• Overcome common challenges in sample program management
• Effectively leverage multi-channel approaches
• Utilize key data points for informed decision-making

The session will conclude with a comprehensive overview of an optimized, multi-channel sampling approach, ensuring you leave equipped with the essential tools and insights to enhance your sample programs.

Attendees will also have the opportunity to ask questions directly to these pharmaceutical experts. Participation is encouraged so please come prepared with any related scenarios you’d like to explore.

The Prescription Drug Marketing Act (PDMA) plays a critical role in ensuring the integrity of the pharmaceutical supply chain.

On a practical level, complying with the PDMA helps prevent counterfeit drugs, promotes transparency, and ensures that drug products are sourced ethically and legally. Adhering to its regulations can significantly reduce risks and improve trust with both patients and healthcare providers.

This workshop will explore practical strategies for navigating PDMA compliance in your everyday operations.

Join us for an insightful workshop as we explore how to leverage data for enhanced compliance monitoring and actionable business insights. In this session, we’ll dive deep into:

• Sampling Data Insights
  What does your data really tell you about compliance risks and business outcomes? Learn how to interpret sampling data to uncover hidden issues and drive decision-making.
• Spend Data Analysis
  Is your organization at risk? Discover how spend data can reveal departmental red flags and guide proactive risk management.
• Effective Data Monitoring
  Understand the techniques and tools to monitor data for risk identification and ensure robust compliance processes.
• Actionable Insights
  Gain the knowledge to turn raw data into strategic insights that support both compliance and business success.

They say, “Teamwork makes the dream work,” and that certainly is a goal for us. Effective communication and collaboration with partners in diverse roles are essential for success in our industry. This session will explore how various field-based employees—such as sales representatives, market access professionals, medical science liaisons (MSLs), nurse educators, and reimbursement specialists—interact and collaborate compliantly.

Workshop highlights will include:

• Understanding Roles: Discover how various field-based positions communicate and contribute to organizational goals
• Best Practices: Learn the “dos” and “don’ts” of interactions for each role
• Managing Preferences: Dive into strategies for engaging healthcare professionals (HCP) who want fewer points of contact
• Balancing Compliance Considerations: Discuss strategies for balancing business needs with compliance considerations

You will gain valuable insights into the compliance and regulatory environment and foster better communication strategies for field interactions.

True vendor partnerships are essential for organizations because they can drive value, efficiency, and innovation. In our case, vendors must provide compliance expertise in overseeing drug sample transactions related to PDMA drug sample accountability.

A trustworthy vendor partnership can differentiate a thriving, successful compliance program from one that fails due to ineffective resource utilization.

Effectively managing metrics is crucial for measuring success and enhancing performance.

Understanding what success looks like and what practices are most effective is vital to building and managing effective vendor relationships.

When issues arise, having a Corrective and Preventive Action Process (CAPA) is critical to improving processes, ensuring that problems are addressed, and preventing them from reoccurring.

Join us for “Power Up Your Partnerships,” where you’ll gain valuable insights and effective strategies for optimizing vendor relationships.

We all have questions from time to time, especially when collaborating with third-party vendors. Knowing the best practices for addressing these questions ensures you receive clear, effective responses. We encourage you to bring your questions to this session, and we’ll do our best to address them.

If you are a drug manufacturer or distributor, you MUST comply with the US state government licensing regulations!

During this workshop, you’ll learn about the complicated—and sometimes frustrating—process of complying with the various state licensing obligations, which is crucial for anyone involved in the manufacturing, distribution, and sale of prescription drugs.

This session will provide a comprehensive overview of the drug manufacturer and distributor licensing requirements across the United States and equip attendees with the tools and knowledge needed to ensure their company complies with state regulations.

Artificial Intelligence (AI) is transforming businesses around the world. As more industries adopt AI tools, staying informed about the latest advancements is essential for driving innovation and growth and ensuring organizational compliance.

This session will offer valuable insights into the potential of AI, covering topics like:

• The core principles of AI and its impact on your sector
• How to integrate AI into your day-to-day responsibilities
• Navigating the ethical and legal considerations surrounding AI

Participants will deepen their understanding of this complex technology and discover how to apply it effectively in their daily tasks.

As companies increasingly leverage social media for product visibility and patient engagement, understanding the FDA’s expectations and potential compliance pitfalls is crucial. This workshop will cover the FDA compliance considerations surrounding product promotion and advertising on social media platforms. Key topics include:

• FDA’s guidance on correcting third-party misinformation on social media
• Navigating character-space limitations while presenting risk and benefit information
• Defining “control” of messaging and its regulatory implications
• Best practices for ensuring compliance when using platforms like Twitter, Facebook, YouTube, and sponsored search engine ads
• Developing internal policies and procedures to monitor and manage social media communications effectively

Attendees will gain practical strategies for aligning social media activities with FDA requirements, mitigating regulatory risks, and safeguarding their company’s reputation in the digital age.

This workshop will cover essential topics to strengthen attendees’ understanding and execution of sampling operations, including:

• Sampling Overview – Introduction to sampling, key benefits, and various sampling program types.
• Project Overview – Identification of stakeholders, process framework, key workstreams, and timeline expectations.
• Project Resources – Best practices, reference documents, document management, sample management accountability, and logistics planning.
• Project Considerations – Cold chain requirements and risk evaluation & mitigation strategies.

Participants will explore innovative strategies and best practices to ensure the success and integrity of their sampling operations.

Discover practical strategies for DEA compliance in this informative session, which promises invaluable insight into topics such as:

• Controlled substance cases filed by the DEA
• The DEA’s position on prescribing controlled substances via telehealth
• Lessons learned from recent cases
• Suspicious order monitoring
• Other DEA-related hot topics

This workshop is an excellent opportunity for attendees to enhance their understanding of DEA compliance.

This workshop will provide a thorough overview of the Prescription Drug Marketing Act (PDMA) and the use of electronic records and signatures under Title 21 of the Code of Federal Regulations (CFR), Part 11.

Participants will explore the critical aspects of compliance with PDMA, focusing on the requirements for maintaining accurate records, ensuring secure electronic signatures, and validating electronic systems. The session will cover best practices for integrating electronic records into existing workflows while adhering to regulatory standards.

Attendees will gain insights into the FDA’s current guidance on enforcement discretion regarding Part 11 requirements, particularly in relation to legacy systems and validation processes. By the end of the workshop, participants will be equipped with practical tools and knowledge to enhance their compliance strategies in managing prescription drug marketing activities.