Innovator Rx Drug Product Labeling 101: From Creation to Change Management

Life Sciences, Pharmaceutical, Medical Device,
  • Thursday, October 20, 2022 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
  • 60 min

This webinar will help companies understand the nuances of global health authority drug product labeling requirements. The featured speakers will explore what research is needed to meet these requirements, how to conduct this research in the most efficient manner and how to create and submit labels. The speakers will further discuss how companies can quickly and accurately verify labels and manage future version changes of labels, documents and submissions. Next, they will examine ways to centralize label change management to better plan, track, curate and support ongoing regulatory label compliance. Finally, the webinar will explain how to intelligently reuse label content data across regions.

Register now to join a panel of regulatory experts and learn about pharma labeling from the basics and beyond! Topics covered will range from global health authority label requirements through the practical process of completing, submitting and continuing to manage drug product labeling.

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://Peter%20Muller,%20Schlafender%20Hase

Peter Muller, Managing Director, Schlafender Hase

For the last 25 years, Peter Muller has worked on software and process improvement projects related to proofreading with Fortune 500 companies from various industries: pharmaceutical, medical device & consumer goods. He has a wealth of experience working with international clients, defining their organization’s goals and helping them leverage new technologies to achieve productivity gains, process improvements and cost savings.

Message Presenter
http://Cham%20Williams,%20IQVIA

Cham Williams, Associate Director, Business Systems, IQVIA

Cham Williams has more than 20 years’ experience in the life science industry working globally for pharmaceutical, consulting and technology solution companies.

His expertise includes managing regulatory technology, business process optimization and systems planning and implementation. As a principal consultant, he has advised clients on regulatory strategy and process development. He started his career at GSK where he was part of a pioneering submissions team recognized for submitting electronic CRFs, which later led to the development of electronic NDAs.

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

Attendees will gain insights into:

  • Global health authority label requirements
  • Label research and creation
  • Label comparison and verification
  • Change management and global labeling orchestration

Xtalks Partner

Reed Tech

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.

Media Partner

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