Achieving Compliance: Pharma Annual Deadlines

Life Sciences, Pharmaceutical Regulation, Pharmaceutical, Pharma Manufacturing & Supply Chain,
  • Wednesday, October 06, 2021

Register for this webinar to join Reed Tech for a complete look at the annual deadlines that pharmaceutical companies are required to meet to become, and remain, compliant with the FDA.

Join us for the live event featuring Reed Tech subject matter experts Gary Saner and David Wilson. This webinar is designed to help regulatory teams understand the best way to navigate these annual requirements and ensure they are complying with all year-end deadlines. Each company responsible for submitting drug product listings will have its own unique schedule for submission to the FDA based on application approval dates and updates to labeling and listing information.

However, the FDA has established several specific reporting periods throughout the year for various electronic drug product submissions. These include Drug Sample Distribution Reports, GDUFA Self-Identification submissionsEstablishment Registrations and No Change Notifications for Drug Product Listings. This webinar will unpack and explain each of these deadlines and how to submit.

Key Takeaways:

  • Overview of Annual Deadlines
  • Year-End Requirements
  • Structured Product Labeling Requirements
  • Data Storage and Management
  • Frequently Asked Questions

To learn more and have your questions answered by the expert speakers, join this webinar on Wednesday, October 6th at 2 PM EDT.

Speakers

Gary Saner, Sr. Manager, Information Solutions - Life Sciences, Reed Tech

Gary Saner is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.

Message Presenter
http://David%20Wilson,%20Reed%20Tech

David Wilson, Sr. Account Executive, Reed Tech

David Wilson assists pharmaceutical companies to achieve compliance through innovative technologies. Reed Tech serves customers with the expertise required in the Life Sciences industry. The services and software tools we provide as part of our Pharmaceutical Services have assisted over 1,000 pharma companies in complying with complex FDA Electronic Drug Listing/Labeling and Registration requirements.

Message Presenter

Who Should Attend?

  • Regulatory Affairs and Operation Leaders
  • Manufacturing
  • Operations and Supply Chain Leaders
  • Global Strategy Business Managers
  • Compliance Officers
  • Regulatory Affairs/Operation Leaders
  • Product Managers
  • Business Analysts

What You Will Learn

In this webinar, participants will learn about:

  • Overview of Annual Deadlines
  • Year-End Requirements
  • Structured Product Labeling Requirements
  • Data Storage and Management

Xtalks Partner

Reed Tech

Reed Tech is the provider of best-in-class information-based solutions and services to meet the needs of the life sciences industry, government agencies, and the intellectual property market. Our customers are located throughout the world and include a wide range of medical device manufacturers and pharmaceutical companies, the U.S. government, numerous Patent Authorities, and IP-driven companies and law firms. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis company.

Life Sciences Solutions Driven by Accuracy and Insight

Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.

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