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Seminar 1: European pharmaceutical regulatory environment

Course Description


The subject area regulatory affairs ensures that the quality, safety and efficacy of the medicinal product is in line with legal requirements for the purpose of marketing safe and efficacious medicinal products solely in the interests of public health. Regulatory affairs is primarily a specialty of the pharmaceutical industry. The function encompasses all strategic, operational and administrative activities required to obtain official authorisation for Clinical Trials, marketing and distributing of medicinal products, post-marketing changes and obligations and manufacture and the activities related to pharmacovigilance. Seminar 1 provides the basis for all activities of a regulatory affairs professional since it imparts detailed knowledge on the pharmaceutical legislation, the regulatory institutions and stakeholders and their interaction and on the Modules 1 and 2 of the marketing authorisation dossier. Modules 3, 4 and 5 of the marketing authorisation dossier are dealt with in Seminar 4 of this course, specifically describing what is relevant for biopharmaceuticals. This seminar furthermore deals with the particulars of small and medium size enterprises and all regulations related to biopharmaceuticals. It also provides the legal details on orphan drug regulations and on the role and activities of the ICH process


- The European Pharmaceutical Legislation
- The regulatory institutions and other stakeholders
- Interaction of international regulatory agencies
- General requirements for the Common Technical Document (CTD), the Marketing Authorisation Dossier - Modules 1 and SmPC, Module 2, Risk Management Plan
- Special legal provisions for biopharmaceuticals
- Orphan Drug Designation - provisions and procedures
- SME - provisions and procedures
- Principles of registration and certification of medical devices and device/drug combinations


- Understand the legal basis of authorisation of medicinal products and registration of medical devices and drug/device combinations
- Provides you with a clear understanding of the EU regulatory system and its stake holders
- Understand the structure of the EMA and its role
- Understand the special legal requirements for biopharmaceuticals
- Understand the principle of the orphan drug designation
- Understand the incentives dedicated to SMEs and the process to obtain a SME status
- Provides you with hands-on knowledge on the Common Technical Document, Modules 1and 2


Day 1: Tuesday, 09 September 2014

09.15 - 10.15 Welcome and introduction to the whole MSc EUCRAF course on biotech-related regulatory affairs (Gabriele Dallmann, EUCRAF)

10.15 - 11.00 Introduction into the European regulatory system (Geneviève Michaux, Hunton & Williams)

How are medicines and devices regulated and why?
What is regulatory affairs?

11.00 -11.30 Coffee break

11.30 - 13.00 The European Pharmaceutical Legislation (Geneviève Michaux, Hunton & Williams)

Essential terms and provisions of the framework defining the marketing of pharmaceutical medicinal products in the EU/EEA

The Common Market in the EU/EEA
Approval and distribution of medicinal products in the EU
Regulations and directives determining the pharmaceutical legislation applicable to the EU/EEA and national pharmaceutical law of the EU member states
Notice to applicants
Obligations of the marketing authorisation holder
Global Marketing Authorisation
Data protection and patents
Types and procedures of referrals

13.00 - 14.00 Lunch

14.00 - 16.00 Regulatory institutions and other stakeholders of the European system of pharmaceuticals, their functions and role (Judith Creba/ Genevieve Le Visage /Silvia Pfaff, Novartis)

Role of the Parliament, Council, EU Commission, DG SANCO
Working effectively with the EMA

EMA Scientific Committees, their interaction and their working parties

Involvement of patient organisations
The national agencies of the EU/EEA member states
The HoA network
The Industry trade associations

16.00 - 16.30 Coffee break

16.30 - 18.30 continued

19.00 Get-together with food and wine

Day 2: Wednesday, 10 September 2014

09.15 - 10.45 Why are biopharmaceuticals special? What legal particulars for biopharmaceuticals do we have? (Gabriele Dallmann, EUCRAF)

Advanced therapies
Emerging therapies and technologies
Plasma and Vaccine Antigen Master Files
Genetically Modified Organism (GMO)
Batch release
Small and Medium Size Enterprises (SME)

10.45 - 11.15 Coffee break

11.15 - 12.45 continued

12.45 - 13.45 Lunch

13.45 - 15.15 The regulatory framework for drug/device combination products (Marielle Fournier, Voisin Consulting)

The EU regulatory framework for drug/device combination products
The specific case of combined ATMP
The US regulatory framework for drug/device combination products
The key challenges raised by drug/device combination products

15.15 - 15.45 Coffee break

15.45 - 17.30 continued

Day 3: Thursday, 11 September 2014

The Common Technical Dossier (CTD)

09.15 - 10.30 Format and content of the marketing authorisation application: The Common Technical Dossier (CTD) (Lidia Cánovas and Michael Schaub, Asphalion, S.L.)

General aspects of the harmonised CTD

Module 1 of the CTD: General information

Application form
Application numbering
Multiple applications: co-marketing and co-promotio
Fees and reduced fees
Proposals (Mock-ups) for packaging, labelling and package inserts
ATC codes
Environmental Risk Assessment (ERA)

Labelling, Package Leaflet and Summary of Product Characteristics (SmPC)

Readability test, Braille, Blue Box

10.30 - 11.00 Coffee break

11.00 - 13.00 continued

13.00 - 14.00 Lunch

14.00 - 16.00 Module 2 of the CTD (Lidia Cánovas and Michael Schaub, Asphalion, S.L.)

Table of Contents (Module 2 – 5)

Module 2.3 Quality Overall Summary
Module 2.4 Nonclinical Overview
Module 2.5 Clinical Overview
Module 2.6 Nonclinical Summary
Module 2.7 Clinical Summary

Risk Management Plan (RMP)

16.00 - 16.30 Coffee break

16.30 - 18.00 continued

Day 4: Friday, 12 September 2014

09.15 - 10.30 International collaboration of agencies (Gabriele Dallmann, EUCRAF)

ICH process: collaboration of the three regions EU, US and Japan
Collaboration with FDA
Collaboration with other agencies: China, India, Brazil

10.30 - 11.00 Coffee break

11.00 - 12.00 continued

12.00 - 13.00 Lunch

13.00 - 14.30 Small and Medium Size Enterprises (SME) (Gabriele Dallmann, EUCRAF)

The particular conditions applicable to Small and Medium Size Enterprises (SME) and the SME office of the EMA
SME Regulation and Incentives
Type of companies assigned SME status
What does the SME Office deliver
Scientific advice

14.30 - 15.00 Coffee break

15.00 - 17.00 Orphan Medicinal Products in the EU/EEA (Rembert Elbers, formerly BfArM)

Legal basis and provisions
Orphan designation
Orphan status
Market exclusivity and further incentives
Annual report
Marketing authorisation procedure

Entry Requirements

English language knowledge

Course Fees

2.800 EUR regular fee, 1.720 EUR for academic institutions/government (+19% German VAT)

Email Enquiry

Recipient: European Centre of Regulatory Affairs, EUCRAF
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