Risk Evaluation and Mitigation Strategies in Structured Product Labeling Format and Additional Pharma Annual Deadlines

Life Sciences, Pharmaceutical Regulation, Pharma Manufacturing & Supply Chain, Medical Device, Medical Device Safety and Regulation, Medical Device Manufacturing & Supply Chain,
  • Wednesday, September 21, 2022

This webinar will take a complete look at the annual deadlines that pharmaceutical companies are required to fulfill to become and remain compliant with the US Food and Drug Administration (FDA).

The 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.

Attendees will gain insights into the following takeaways:

  • Overview of annual deadlines
  • Year-end requirements
  • Structured Product Labeling (SPL) requirements
  • New REMS (Risk Evaluation and Mitigation Strategy) in SPL deadline
  • Data storage and management
  • Frequently asked questions

Join the featured speakers, Reed Tech subject-matter experts David Wilson and Julia Frasch, as they explore how pharmaceutical companies can navigate through structured product labeling requirements and other new guidelines.

Speakers

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

David Wilson, Pharma Team Lead, Reed Tech

David Wilson is a subject-matter expert in the pharmaceutical industry, global health authorities and structured product labeling. For the past decade, he has been assisting pharmaceutical companies to achieve compliance through innovative technologies. David is an expert on upcoming deadlines and expanded regulations. He has been a featured speaker for a variety of industry organizations including IRISS and DIA.

Message Presenter
http://Julia%20Frasch,%20Reed%20Tech

Julia Frasch, Pharma Account Executive, Reed Tech

Julia Frasch is an Account Executive at Reed Tech. She helps pharmaceutical companies save time and effort complying with the US Food and Drug Administration (FDA) and Health Canada drug registration requirements. In her nearly three years at Reed Tech, Julia has developed subject-matter expertise in the life sciences industry and assisting her customers in the nuanced compliance processes.

Message Presenter

Who Should Attend?

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

What You Will Learn

  • Overview of annual deadlines
  • Year-end requirements
  • Structured Product Labeling (SPL) 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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