Wednesday, May 7 • 3:00pm-4:00pm

We’re excited to announce “Enhancing Compliance: A Workshop on the Prescription Drug Marketing Act and 21 CFR Part 11 Validation,” presented by Alan Minsk, General Counsel of the Sharing Alliance and Partner at Arnall Golden Gregory LLP. This workshop aims to provide an understanding 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 workows 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. You don’t want to miss this!

Thursday, May 8 • 3:00pm-4:00pm

Discover practical strategies for DEA compliance in this informative session with renowned attorney and industry expert John A. Gilbert, Jr.!

Mr. Gilbert is a recognized authority specializing in regulatory and legal matters involving controlled substances, prescription drugs, and precursor chemicals. He has a comprehensive understanding of the regulations governing the drug supply chain, with extensive knowledge of international, federal, and state laws.

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 to learn from one of the industry’s foremost experts and enhance your understanding of DEA compliance. We hope to see you there!

Friday, May 9 • 9:30am-10:30am

Get ready to dive into drug sampling alongside industry leaders Bill Samuelson and Jennifer Kretsch! Their workshop will cover essential topics to strengthen your 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.

Bill and Jennifer will explore innovative strategies and share best practices to ensure success and integrity in your sampling operations. You won’t want to miss this!