Global Regulatory and Submissions Management in the Pharmaceutical Industry

9 - 10 February 2017

Understanding of ever increasing regulatory requirements, ambitious roadmaps for harmonization lying ahead and drastic changes in the regulatory landscape is essential to overcome challenges and create solutions.

Key Topics

  • Regulatory intelligence and its practical impact
  • eCTD and MAA special cases
  • EU Telematic strategy towards 2020
  • CESP, communication and expectations of different stakeholders
  • Global regulatory strategy: Keeping up with the expectations and complexity
  • Harmonization: uniform architecture and centralized master data resource
  • Dengue vaccine registration worldwide case study
  • Operational efficiency: effective data exchange and simplified processes

The Next Generation of RIM

Keynote Presentation
Day 2 - February 10, 9:10 AM

  •    Recognize the value and business potential of the Next Generation of integral RIM
  •    Follow the standardized migration approach from legacy DMS to the Next Generation
  •    IDMP Impact assessment and Business preparation

Speaker: Romuald Braun, VP Strategy, Life Sciences

Since 1992 Romuald has been working in roles related to Compliance, Document Management, Content Management in the Life Sciences industry. Romuald has been playing roles on the client side and in consulting, in delivery and in sales, in project roles and in line responsibility. He worked in client server and in cloud environments, in Europe and in US. Romuald is holding the academic degree of Master of Drug Regulatory Affairs in addition to his Engineer diploma in Data Technology. Romuald has been also a frequent speaker on topics relating to content management adoption in life sciences.

Key Takeaways

  • Merck’s strategy for integrating regulatory intelligence in development teams and regional submission strategies
  • Sanofi's strategy for the worldwide registration of the Dengue vaccine
  • IDMP readiness – a case study of a long-established medium-sized company
  • ISO IDMP updates & clarifications
  • Tips on optimal use of the CESP
  • A basis for improving communication leading to time-efficient submissions and approvals
  • Current Status and next steps of IDMP

Venue

Renaissance Wien Hotel
Linke Wienzeile/Ullmannstrasse 71
1150 Vienna
Austria