Autumn Introductory Course 2017 - Day 4

Monday 13 November (Day 1) Chair: Marion Kreitz, Bencard Allergie GmbH


Arrival and Registration

Marion Kreitz Bencard Allergie GmbH Ronald de Meijer Astellas Pharma Europe B.V.


Opening and introduction of day


Welcome and Opening Address

How does Regulatory Affairs fit into the Picture? • The importance of Regulatory Affairs • Where does Regulatory Affairs fit into the ‘normal’ structure of a pharmaceutical company • The role of a Regulatory Affairs Professional • A future in Regulatory Affairs • Current hot topic – transparency • Future of the Pharmaceutical Industry Development of Pharmaceutical Legislation • The development of regulations, directives and guidelines • Working parties • Opportunities to influence legislation • New legislation Common Technical Document Module 1: Administrative Information & Prescribing Information • Introduction to CTD • Overview of Module 1 • Type of application (including abridged applications) • Summary of Product Characteristics (SmPC) • Application form including appendices • PIL user testing • EU regional requirements Break

Andrew Thornley TOPRA


Birka Lehmann Formerly working for Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)



Hans van Bruggen eCTDconsultancy


e-Submissions • Regulatory guidance leading to eCTD • Prerequisites for proper eCTD usage • Other e-submission initiatives including PIM • EVMPD and IDMP • E-submission readiness

Hans van Bruggen eCTDconsultancy


Marion Kreitz Bencard Allergie GmbH

18:45 19:30 20:00

Case Study 1 – Ice Breaker

Welcome drinks


Made with FlippingBook Online document