CEMDC, Semmelweis University

Module 5: Regulatory Affairs; Drug Safety & Pharmacovigilance

Practical Information

Commencing Date:
Budapest Hungary

Teaching Methodology:
Blended Learning
Credits :
Short courses (CPD): 15 ECTS

European Fees:
800 EUR
Scholarship Possibilities:

Course Contact

CEMDC, Semmelweis University

University Accreditation: Yes

Centre of Excellence


Module Leaders of the regulatory section: J. Klimas, Slovakia and A. Irs, Estonia - under discussion In the module regulatory aspects of medicines development and application through the entire life cycle of medicines will be highlighted Module Leaders of the Pharmacovigilance section: Z. Guney, Turkey and L. Stankovics, Hungary In the pharmacovigilance section of this module the process of side effect reporting will be described. In addition to the clinical pharmacologic evaluation of adverse events, the industrial and international regulatory management of reported events will be described in the frame of the pharmacovigilance organisation. Finally the concept risk management will be reviewed.


General principles of medicines regulation (both pre- and post-approval) at EU and global level Impact of medicines legislative requirements on regulatory activities within a pharmaceutical company Role of national agencies and international bodies in medicines regulation National provisions for management of (1) off-label / unlicensed use of medicines (2) controlled drugs Place of International Conference on Harmonisation (ICH) in medicines regulation (including Common Technical Document [CTD]) Regulatory processes in the EU / EEA areas Regulation and legal considerations of Product Information Principles and practical application of medical devices regulation Roles of the various stakeholders (including pharmaceutical and other healthcare professionals, investigators, regulatory authorities) in drug safety and pharmacovigilance Classification of adverse events / adverse drug reactions Safety reporting requirements (according to the type of adverse event / reaction) pre- and post-approval Ongoing management of drug safety issues pre- and post-approval (including Risk Management Plans [RMPs], Periodic Safety Update Reports [PSURs]); ongoing benefit / risk assessment throughout the life-cycle of a medicine Role of pharmacoepidemiology in the life-cycle management of a medicine Factors influencing medication safety from the perspective of each stakeholder

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