The courses in this module will give you an overview on medicines regulation including the different marketing authorisation procedures, benefit-risk assessment, pharmacovigilance, pharmacoepidemiology and other relevant aspects, and the role which patients can take in these processes.

Important note: term ‘regulations’ can be used in different contexts while an EU regulation is a legal act of the European Union that becomes immediately enforceable as law in all member states simultaneously. EU regulations can be distinguished from EU directives which, at least in principle, need to be transposed into national law.

Available courses

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Introduction to Regulatory Affairs
Regulatory Affairs

Number of topics: 6

 
After completing the course, you will be able to:
 

  • Outline the principles of medicines regulation 

  • Describe the legislative framework for medicines regulation

  • Describe the purpose and function of the International Council of Harmonisation and outcomes of its work

  • Explain the reasoning behind the implementation of the Common Technical Document

  • Understand the current EU regulatory requirements (pre and post-authorisation) for a medicinal product

  • Explain the concept of benefit and cost-effectiveness

  • Describe the various roles patients can play in approval and benefit-risk evaluation pre- and post-approval of medicines

  • Explain the role of modern pharmacopoeias

  • Describe the roles of the European Directorate for the Quality of Medicines (EDQM)

  • Understand and describe the key principles of GoodxPractice

  • Describe the key elements of GxPs most relevant in pharmaceutical medicine
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Epidemiology and Pharmacoepidemiology
Regulatory Affairs

Number of topics: 4

 
After completing the course, you will be able to:
 

  • Illustrate the basic concepts of epidemiology

  • Describe the application of epidemiological research

  • Explain the concepts of prevalence and incidence in epidemiology

  • Describe the principles of pharmacoepidemiology, its study types and data sources and their application in research

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Pharmacovigilance - Risk management
Regulatory Affairs

Number of topics: 5

 
After completing the course, you will be able to:
 

  • Outline the principles of pharmacovigilance

  • Explain the major steps in pharmacovigilance signal management

  • List the key stakeholders in pharmacovigilance and their roles

  • Compare Post Authorisation Safety Studies (PASS) and Post Authorisation Efficacy Studies (PAES)

  • Outline the organisation of public hearings

  • Explain the concept and structure of EudraVigilance

  • Outline the principles of risk management for medicinal products in the European Union (EU) including the risk management plan

  • Explain the EU specific measures for additional monitoring
  • Outline the concept of safety communication
  • Relate the ‘Direct to health care professionals communication’ to the overall principles of safety communication
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Product information and information to the public

Regulatory Affairs

Number of topics: 4

 
After completing the course, you will be able to:
 

  • Describe the components of product information and access to information they contain

  • Outline the legal mandate and review process of product information
  • Explain the difference between advertising and promotion of medicines to the general public and healthcare professionals with reference to the legal framework

  • Explain the relation between different levels of Codes of Conduct and their differentiation to Codes of Ethics

  • Relate the EFPIA Code of Practice to the underlying EU Directive 2001/83
 
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Regulatory procedures- Marketing-Authorisations and their lifecycle management
Regulatory Affairs

Number of topics: 5

 
After completing the course, you will be able to:
 
  • Understand the basics of regulatory affairs functions in pharmaceutical companies
  • Understand and explain the principal EU regulatory legal framework and procedures for authorising a medicine
  • Understand and describe the main special cases in marketing authorisations and their particular conditions
  • Explain the non-standard procedures for marketing authorisations and their differences
  • Describe the main variation types of a marketing authorisation
  • Describe and discuss the regulatory steps in a marketing authorisation application (MAA) for a medicine, including the different types of MAAs and their legal basis
  • Describe the EU provisions for early access and use of medicines outside of or without a marketing authorisation
 
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