TUTORIAL 2 - REGULATORY INFORMATION MANAGEMENT AND IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP)

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REGULATORY INFORMATION MANAGEMENT AND IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP)

Co-Instructors:

Frits Stulp, IDMP Program Manager, Astellas Pharma, Netherlands

JasperRiksen, XEVMPD / IDMP Consultant, Astellas Pharma, Netherlands

Michiel Stam, Regulatory Operations Scientist, eCTDconsultancy, Netherlands

The implementation of IDMP in the EU is now gathering pace with agreements on the scope of Iteration 1 for Authorised Medicinal Products, on Organisation information and how Controlled Vocabularies will be managed. The scope of Iteration 1 is greater than that of XEVMPD and will bring some challenges in obtaining and maintaining data. Companies will need to address how they manage these challenges, in the shorter-term for Iteration 1 and in the longer-term for subsequent iterations which will have much wider scope and be significantly more complex to address. The tutorial will address the shorter-term requirements for Iteration 1 and the longer-term strategic needs of managing IDMP data for regulatory compliance, use in healthcare scenarios and for internal business benefit and efficiency.

Discussion topics will include:

Status of implementation of IDMP implementation in EU (and other regions)

Medicinal Product data for Iteration 1 (e.g. differences from XEVMPD, challenges)

Impacts of requirements for Substances, Organisations and managing Controlled Vocabularies

Implementing IDMP – case examples including building the business case

Strategic approaches to IDMP data management (RIM, MDM, EDM, RDM, Structured Content Authoring)

Target Audience

Professionals involved in the following areas:

Regulatory Information Management

Regulatory Information Technology

Reference- and Master Data Management

Supply Chain

XEVMPD

Pharmacovigilance

Quality Assurance

Standardisation and Harmonisation

TUTORIAL 2 - REGULATORY INFORMATION MANAGEMENT AND IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP)

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