Sponsored Webinar: IDMP Roadmap To Success

Sponsored Webinar: IDMP Roadmap To Success
FREE SPONSORED WEBINAR - On 22 February 2021, the European Medicines Agency published the EU IDMP Implementation Guide version 2. This long-anticipated event is critical for the life sciences industry as it starts the clock for the implementation of the product and substance data submission iteration 1 timelines in the EU. But what does it mean to companies and what must be considered? Are we IDMP-ready?

Date:
13 April
Time: 15:00 BST (GMT+1) / 16:00 CEST

This webinar is sponsored by Amplexor.



Disclaimer
Whilst TOPRA is running this webinar for Amplexor, this is not an endorsement of Amplexor, Amplexor's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

In this webinar,  Amplexor will discuss the roadmap to IDMP success, and elaborate on key aspects, in particular:

  • Major changes IDMP is introducing to the industry
  • Shifting from a document to a data-centric world
  • Opportunities and challenges of bringing IDMP to fruition
  • IDMP influence on the ecosystem of people, data, process and technology
  • Success factors of IDMP implementation

The webinar will conclude with a demonstration of practical examples of how the AMPLEXOR Life Sciences Suite is supporting companies on the IDMP implementation journey. 

Learning objectives

  • How to address the challenges of implementing IDMP
  • How to change your approach to data-centric content from a document-centric world
  • How to benefit from the success factors of an IDMP implementation

Suitable for

  • Director Regulatory Affairs
  • Director Regulatory Operations
  • Director Data Standards / Master Data Management
  • Manager / Senior Manager / Associate Director / Director / Head of Regulatory Information Management / Regulatory Informatics
  • Associate Director / Director / Head of Submission Management
  • Associate Director / Director / Head of Registration Management
  • Director / Head of Regulator Compliance
  • (Global) Regulatory Lead
  • Head of Labeling (& Promotional Material)
  • Regulatory Affairs Manager / Specialist / Senior Manager
  • Dosser Specialist, Publisher
  • IT/R&D Regulatory Project / Program Managers
  • Regulatory Business Process Managers / Business Analysts / Business Leads
  • Validation Manager
  • Training Manager
  • IT Vendor Manager Solution Architect, Software/Solution Engineer, R&D Solution Expert
  • R&D QA Specialist 

Speakers

Agnes Cwienczek - Head of Product Management and Consulting, Amplexor Life Sciences. 

Agnes’ main responsibilities are the provision of business and compliance requirements for the Amplexor Life Sciences Suite. She also manages the Life Sciences Consultants in the delivery of process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, Submission Management and Labeling Management.

David Gwyn - Vice President, Amplexor Life Sciences

With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience. As a Vice President for Amplexor Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite to ensure that the solution meets the needs of the customer.

 

When
13/04/2021 15:00 - 16:00
Where
ONLINE
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