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, specialist MaryLou Schoonover will dive into 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.
Chuck Gallagher is an expert in the field, offering invaluable insight into the boundless potential of AI. Here’s what to expect from his session:

• Explore the core principles of AI and its impact on your sector
• Learn how to integrate AI into your day-to-day responsibilities
• Navigate 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. During this workshop, Alan Minsk will discuss FDA compliance considerations surrounding product promotion and advertising on social media platforms. He’ll explore key topics, including:

• 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.

Dive into drug sampling alongside industry leaders Bill Samuelson and Jennifer Kretsch! Their 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 with renowned attorney and industry veteran John A. Gilbert, Jr.! With his profound expertise in DEA compliance, Mr. Gilbert will provide invaluable insight from a unique legal perspective. He’ll cover 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 learn from one of the industry’s foremost experts and enhance their understanding of DEA compliance.

During this workshop, industry leader Alan Minsk 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.