Compliance Key INC - Regulatory Compliance Training
Joel Finkle is Director, Regulatory Innovation and IDMP Strategy for ACUTA. In this role he brings new technologies and regulatory data standards to ACUTA's bio/pharmaceutical customers to ensure compliance and process improvements.
Overview
This session will review the basic requirements of the initial planned European implementation of the ISO IDMP standard, then explore how the data for a product could be gathered for entry into a RIM system or what is expected in the agency web portal. Benefits of integration in a RIM environment, and downstream use of the data, will be covered.
Why should you attend this webinar?
Compliance with IDMP is not expected for a couple years, but the amount of preparation for existing products is extensive. Getting ahead of the deadlines will make compliance possible, while adding value by codifying the data found in company documentation. The downstream use of IDMP data for regulatory intelligence, marketing and supply chain will also add value to your company.
Areas Covered in the Session:
- ISO IDMP Standard Overview
- European Medicines Agency (EMA) Implementation Plans and Progress
- Mapping data from XEVMPD to IDMP
- Gathering details from the Summary of Product Characteristics (SMPC)
- Completing the European Requirements from submissions and other documentation
Who can Benefit:
Regulatory Operations Staff and Management
Regulatory Affairs Staff and Management
Regulatory Affairs Staff and Management
Compliance Key INC
717-208-8666
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