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Overview

DIA is pleased to announce a New! Clinical & Regulatory Operational Excellence Forum


WHY IS THIS FORUM ESSENTIAL?

The increasing complexities in today’s drug development require a close link between Clinical Operations and Regulatory Operations to embrace working solutions and partnerships. This highly interactive forum will enable you to perform complex tasks to the highest operational standards to shorten turnaround times and reduce queries and re-creation in your development programmes.

We are bringing together experts across the fields of Clinical Operations, Records and Document Management, Pharmacovigilance and Regulatory Affairs. Moderated workshops will look at different ways to implement working solutions.

The meeting will be based on selected abstracts that showcase working solutions and will allow attendees to learn from implemented best practices.

 

Featured topics

  • Clinical Operations, eTMF
  • Regulatory Operations
  • Pharmacovigilance
  • Electronic Data Management
  • Quality, CMC, Serialization, Compliance
    • Who should attend?

      • Health Care- and R&D Professionals in the areas of Electronic Document Management, IT and Process Innovation
      • Clinical Operations and Regulatory Affairs that want to excel in their day-to-day work
      • R&D Quality Leads, as well as Trial Managers and Drug Programme Leads & Clinical and Regulatory Project Managers that need to get an overview of the latest gold standards in R&D Operational Excellence to set the standards for high-performing cross functional drug development teams
      • New Technical Solution Vendors (data capture or data handling, software companies for data management) that want to showcase implementatoins utilising their solutions or want to understand and adopt to changing customer needs

       

      Program Committee

      • Marta   Arias-Salgado
        Marta Arias-Salgado Executive Director; Global Clinical Trial Operation
        Merck Sharp & Dohme, Netherlands
      • Hans  van Bruggen, MSc
        Hans van Bruggen, MSc Regulatory Affairs Scientist
        eCTDconsultancy B.V., Netherlands
      • Michael  Horn, PharmD
        Michael Horn, PharmD Head of Division Licensing 1
        Bundesinstitut Für Arzneimittel Und Medizinprodukte, Germany
      • Karen Jane Roy, MPharm
        Karen Jane Roy, MPharm Senior Vice President, Client Solutions
        Phlexglobal, United Kingdom
      • Peter  Schueler, MD
        Peter Schueler, MD Senior Vice President, Drug Development Services
        ICON , Germany
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