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 new forum will focus on excellence in operational implementation of key actual deliverables in the areas of Sponsors & CRO’s and Vendors, Clinical Operations, Records and Document Management and Regulatory Affairs. The workshop style will allow in-depth discussions with the expert instructors.

Workshop 6: SUBMISSION PLANNING AND CONTROL THROUGH A PRODUCT LIFECYCLE TODAY AND TOMORROW

Wednesday, 13 September | 15:30

Workshop Co-Presenters:

Tomaž Kobe, Head of Delivery Management, Amplexor, Slovenia
Mark Cottingham, F. Hoffmann-La Roche, Switzerland
Romuald Braun, VP Strategy Life Sciences, Amplexor, Switzerland

  • Trigger audience’s minds into rethinking the automatization of submission execution process
  • Understand how the submission process can be optimized further while increasing oversight and regulatory compliance

Featured Topics

  • Clinical Operations, eTMF
  • Regulatory Operations
  • Pharmacovigilance
  • Electronic Data Management
  • Quality, CMC, Serialization, Compliance

Venue

Mercure Hotel MOA Berlin
Stephanstrasse 41
10559 Berlin, Germany