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Regulatory Submissions, Information, and Document Management Forum

Session 10 Track 2: Along the Path of Drug Approval; A Hodgepodge of IDMP, EMA Support for SMEs, and ICH M11 CeSHarP

Session Chair(s)

Michiel Stam

Michiel Stam

  • Director Regulatory Information Management
  • Qdossier - A Celegence Company, Netherlands
During this session, presenters will cover a variety of different topics. From a discussion on importance of semantics for IDMP to the benefits of getting EMA’s SME support, and an overview of the ICH M11 Clinical electronic Structured Harmonized Protocol (CeSHarP) initiative. These seemingly unrelated topics share one common goal; efficient, consistent, and reliable exchange of information sponsors and regulators to promote innovation and development of new medicines.
Learning Objective :
  • Assess the impact of semantics on IDMP useability
  • Describe the latest developments on ICH M11 guideline, protocol template and technical specification
  • Describe the Standards Development Organization (SDO) engagement process to enable electronic information exchange
  • Understand how US SMEs can benefit from the EMA SME status and what the advantages are

Speaker(s)

Matthias Sijtstra

EMA's Approach to Support Innovations Coming from Small- and Medium Sized Enterprises

Matthias Sijtstra

  • Senior Regulatory Data Specialist
  • Qdossier, A Celegence Company, Canada
Hans van Bruggen, MSc

IDMP is about semantics

Hans van Bruggen, MSc

  • CSO
  • Qdossier, a Celegence Company, Netherlands
Vivian Combs, MS

ICH M11 Clinical electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange

Vivian Combs, MS

  • Director of Scientific Communications
  • Eli Lilly and Company, United States