FORUM Institut für Management GmbH

Arzneimittelzulassung fuer Einsteiger/EU-Zulassung fuer Einsteiger

Practical Information

Commencing Date:
Contact course provider
varies Germany

Teaching Methodology:

Scholarship Possibilities:

Course Contact

Henriette Wolf-Klein

00496221 500 680


Office Link

FORUM Institut für Management GmbH

University Accreditation: No

PharmaTrain Centre


This introductory course will prepare you for all operational tasks in Regulatory Affairs. You will learn the details of the admission procedures in Europe and become familiar with the necessary admission documents as well as with the challenges of the compilation. Your tasks in lifecycle management will be trained in practical exercises. Dieser Einsteigerlehrgang macht Sie fit für alle operativen Aufgaben in Regulatory Affairs. Sie lernen die Details der Zulassungsverfahren in Europa. Sie kennen anschließend die notwendigen Zulassungsunterlagen sowie die Herausforderungen bei der Kompilierung. Ihre Aufgaben im Lifecycle-Management können Sie dabei in einigen praktischen Übungen trainieren.


- You know the admission procedures in Europe. - You are familiar with the process requirements in the admission procedures and the associated deadlines. - You are able to choose the appropriate approval procedure for your own product. - You can accompany the submission procedure and related process. - You know the characteristics of generic submissions. - You can compile the necessary approval documents (Q, E, S). - You know the structure of SmPC and package insert. - You understand the principles of electronic submission. - You know the requirements of Lifecyle management and you have trained change management by means of many practical examples. Was Sie nach Lehrgangsende wissen: - Sie kennen die Zulassungsverfahren in Europa. - Sie kennen die Prozessanforderungen in den Zulassungsverfahren und die zugehörigen Fristen. - Sie sind in der Lage, das passende Zulassungsverfahren zum eigenen Produkt zu wählen. - Sie können den Einreichungs- und Verfahrensprozess begleiten. - Sie kennen die Besonderheiten generischer Einreichungen. - Sie können die notwendigen Zulassungsunterlagen zusammenstellen (Q, E, S). - Sie wissen den Aufbau von SmPC und Packungsbeilage. - Sie verstehen die Prinzipien der elektronischen Einreichung. - Sie kennen die Erfordernisse des Lifecyle-Managements und haben das Änderungsmanagement an vielen praktischen Beispielen geübt.

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered