Autumn Introductory Course 2017 - Day 4

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

13:30

Arrival and Registration

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

14:00

Opening and introduction of day

14:05

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

14:30

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

15:20

16:15

Hans van Bruggen eCTDconsultancy

16.45

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

17:45

Marion Kreitz Bencard Allergie GmbH

18:45 19:30 20:00

Case Study 1 – Ice Breaker

Welcome drinks

Dinner

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