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Seminar 7: The roles of the supervising authorities and the essential characteristics of quality systems

Course Description


Companies manufacturing, testing or distributing active ingredients or medicinal products, clinical centres conducting clinical trials and research organisations performing studies need to follow common standards of quality system requirements. The quality system is supervised by national inspectorates who increasingly co-operate globally. If the establishment inspected is found to be compliant with the relevant requirements a license is issued as an authorisation to manufacture, test or distribute the medicinal product or active ingredient.
With the introduction of ICH Q 8, 9 and 10 principles, and with the increasing global trade of active ingredients and products, quality systems become more and more important in ensuring their quality.
The primary purpose of a quality system is to ensure that adequate quality standards are used and maintained. The Good Manufacturing Practice (GMP) applies to the manufacture and control of active ingredients and final dose forms of pharmaceuticals and their clinical supply, the Good Laboratory Practice (GLP) to non-clinical investigations of new compounds, the Good Clinical Practice (GCP) to the conduct of clinical studies, the Good Distribution Practice (GDP) to the storage and distribution of medicinal products.


- Principles and underlying legislation for the establishment of GMP, GLP, GCP
- GMP authorization - procedures in the EU and requirements for third countries
- The supervising authorities - Role of national inspectorates and EMA
- Experience with GMP - inspections by inspectorates from USA, EU, Japan
- Compliance and steady optimisation of production and processes
- Role of EDQM and OMCLs
- Certificates of suitability
- The PIC-S and WHO
- The Rapid Alert System
- Counterfeits


- Understand the characteristics of a quality system and the particulars of the different types of GxP
- Understand how regulatory affairs is connected to the Quality System
- Become familiar with the legislation and guidelines defining the rules for GxP
- Learn how national inspectorates including those from different regions collaborate on facility inspections and which role play the individual stake holders
- Understand how supervision is executed and inspections are conducted
- Understand the function and responsibilities of the Qualified Person
- Recognise what is special with GMP and GDP for biopharmaceuticals
- Understand ICH guidelines 8, 9 and 10
- Understand compliance versus process optimisation


Day 1, Wednesday, 22 July 2015

09.00 - 09.15 Welcome and introduction (Ralf Hess, Parexel)

09.15 - 10.45 European Directorate for the Quality of Medicines and Healthcare (EDQM) (Susanne Keitel, Director EDQM)

Certificate of suitability

10.45 – 11.15 Coffee break

11.15 – 12.45 Characteristics of quality management systems – an introduction (Ralf Hess, Parexel)

Which quality management systems apply in the EU and how they are regulated and executed
Who supervises the companies in the EU and in third countries and how this supervision is authorized and documented

12.45 - 13.45 Lunch

13.45 - 15.00 Structure and role of the supervising authorities (Ralf Hess, Parexel)

Inspections and supervision and the role of national inspectorates
Upon importation into the EU/EEA
Role of the EMA

15.00 – 15.30 Coffee break

15.30 - 16.30 The principles of GMP (Ralf Hess, Parexel)

Legal requirements for obtaining a manufacturing authorisation or an authorisation for importation
Obligations of a holder of a manufacturing authorisation or an authorisation for importation

Company’s responsibility in batch release and The Qualified Person

The Qualified Person for marketed products or Investigational Medicinal Products (IMPs)

The principles of GDP

Maintenance of the level of quality throughout the distribution chain

The Rapid Alert System

Product defects


16.30 - 17.30 Special GMP considerations for biopharmaceuticals including advanced therapies (Gabriele Dallmann, EUCRAF)

What is special for biopharmaceuticals
GMP for starting materials
GMP of blood products and blood components
Are biopharmaceuticals subject to counterfeits

17.30 – 18.30 The Regulatory Affairs department at the interphase (Gabriele Dallmann, EUCRAF and Ralf Hess, Parexel)

Which role the Regulatory Affairs department has at the interface of GMP authorization of manufacture and testing, GLP compliance of pre-clinical testing and GCP compliance of clinical trials
How supervision works – when an inspection is required – who performs the inspections – which authorization documents are required and how they are maintained – when and how the documents are submitted to agencies for CTA and marketing authorization

18.30 End of Day 1

19.00 Get-together with food and wine

Day 2, Thursday, 23 July 2015

09.00 - 10.30 Experience with inspections conducted by the different inspectorates from Europe, U.S. and Japan (Bernd Raffelsberger, formerly Pfizer)

How an inspection is performed

10.30 – 11.00 Coffee break

11.00 – 12.30 continued

12.30 – 13.30 Lunch

13.30 – 15.00 Surveillance of medicines through testing in the EU/Europe (Karl-Heinz Buchheit and Catherine Milne, EDQM)

OMCL Network
CAP testing program and Market Surveillance
Official Control Authority Batch Release (OCABR)

15.00 – 15.30 Coffee break

15.30 – 17.00 The principles of GLP (Ralf Hess, Parexel)

Recording, archiving, reporting investigations
Global Implementation and mutual recognition
The competent authorities

17.00 End of Day 2

For Full Course students:

Introduction of Homework Seminar 7
Day 3, Friday, 24 July 2015

09.00 – 10.30 The principles of GCP (Dagmar Chase, Clinrex GmbH)


o Why we have GCP

o Declaration of Helsinki

o The ICH GCP process

o Ethical and scientific principles in clinical trials to ensure protection of trial subjects and integrity of trial results

The responsibilities of sponsors, e.g.

o Quality Control and Quality Assurance
(Monitoring and Auditing)

o The interface to service providers

o GCP information flow and reporting requirements

The responsibilities of investigators, e.g.

o How to delegate trial tasks within a team

o Protocol adherence

o Informed Consent Procedure

o Source Data and Case Report Forms (CRFs)

o GCP information flow and reporting requirements

Typical GCP Inspection Findings

10.30 – 11.00 Coffee break

11.00 – 12.30 continued

12.30 – 13.30 Lunch

13.30 – 14.30 continued

14.30 End of Seminar 7

Entry Requirements

English language knowledge

Course Fees

2.100 EUR regular fee, 1.320 EUR for academic institutions/government (+19% German VAT)

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Recipient: European Centre of Regulatory Affairs, EUCRAF

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