Sponsored Webcast: Practical Advice and Next Steps to Ensure PLM Portal Readiness (On demand)

Member: $0 | Nonmember: $50
Explore EMA's PLM portal in our webinar, spotlighting recent activities and data insights. Learn about eAF, PMS, IDMP, and practical data load considerations.

Presenters will summarize recent and upcoming EMA Product Lifecycle Management (PLM) activities, which will be supported by the PLM portal. Participants will gain insights into the current state of implementation and dependencies between the new electronic application form (eAF), the electronic Product Information (ePI) initiative, the Product Management System (PMS), and the Identification of Medicinal Products (IDMP).

Moreover, our presenters will dive deeper into the data related aspects of the initial data load into the PMS system, considering the IDMP implementation guidelines. Practical insights will be shared when it comes to preparing your current data and analyzing the plans around the generation of pharmaceutical products, packaged-and manufactured items.

Don't miss this opportunity to stay informed and equipped with practical knowledge to navigate EMA's PLM landscape

Registration Fees & Deadlines

Member$0 | Non-Member $50

Learning Objectives

  • Understand the current state of eAF, PMS, and IDMP integration within EMA's PLM portal
  • Gain insights into the recent PLM implementation activities and next steps
  •  Acquire practical knowledge for preparing and analyzing data in scope of PMS

Who Should Attend?

Professionals involved in Regulatory Affairs, Pharmacovigilance, CMC, Quality Assurance, and information technology within the pharmaceutical and regulatory domain. This event is tailored for individuals seeking to enhance their understanding of EMA PMS activities and contribute to global collaboration in medicinal product lifecycle management.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Speakers

Leslie Cort

Sowmya Raju
Senior Regulatory SME, Celegence

Stephanie Seidel

Michiel Stam
Director Regulatory Information Management, Celegence

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